Endometrial ablation, supracervicals, and laparoscopic ... · bleeding in future, she will need to...

Endometrial ablation, supracervicals, and laparoscopic trachelectomy Matthew Siedhoff, MD MSCR Associate Professor Minimally Invasive Gynecologic Surgery Cedars-Sinai ® UCLA David Geffen School of Medicine

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Objectives

• Review randomized data about endometrial ablation and supracervical hysterectomy compared with total hysterectomy.

• Review putative risks of ablation and retained cervix. • Using video and slides, show each surgical step in resection of cervix after a

supracervical hysterectomy was done.

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Disclosures

• Consultant ¡ Applied Medical ¡ Olympus ¡ Medtronic ¡ Caldera Medical ¡ Cooper Surgical

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Disclosures

•  I am not a GYN oncologist

•  I am a benign gynecologic surgeon who eagerly looks for oncoreductive opportunities for my patients

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Endometrial ablation

True or False?

10% of women who undergo endometrial ablation will ultimately fail and require a hysterectomy

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Case 1

• 32yo g0 with premature ovarian failure • Treated with OCsà Endometrial ablation

“Discussed that we do not need to check estrogen levels but rather can treat her symptoms. We may want to decrease dose in future; however, at this time given her age it is reasonable to use increased dose. Also, we discussed estrogen only is acceptable since she has had endometrial ablation. If she develops spotting or bleeding in future, she will need to let us know since there may be small areas of endometrium which were not burned during procedure which can place her at small risk for hyperplasia.”

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Case 2

• 50yo 18 wk fibroid uterus ¡ Endometrial ablation two years prior, improved bleeding, but remains “extremely

symptomatic” with pelvic pain and dysmenorrhea ¡ Pre-ablation bx negative; “I have not been able to biopsy her since the ablation as I

might expect.” ¡ Tubal ligation 10 years ago ¡ Medhx: diabetes, hyperlipidemia, 3-agent HTN with kidney disease ¡ BMI 36 kg/m2

Endometrial ablation history

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10

Dührssen Berliner Klinische Wochenschrift 1898

1898


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Bardenheuer Zentralblatt fur Gynakologie 1937; Wortman JMIG 2015

1936

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1937

1967

1971

Schultze Cal West Med 1937; Cahan AJOG 1967; Droegemueller Obstet Gynecol 1971


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Resectoscopic endometrial ablation (REA) § Laser, rollerball, loop electrode

Non-resectoscopic endometrial ablation (NREA) § AKA global or 2nd gen endometrial ablation devices § Bipolar radiofrequency (Novasure®) § Hot liquid filled balloon (ThermaChoice®) § Cryotherapy (Her Option®) § Circulating hot water (Hydro ThermAblator®) § Microwave (Microwave Endometrial Ablation)

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Types of Endometrial ablation

ACOG Practice Bulletin Obstet and Gynecol 2007/2018

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Endometrial ablation complications

• Pregnancy after endometrial ablation • Pain related obstructed menses • Hematometra, post-ablation tubal sterilization

syndrome (PATSS) • Treatment failure • Repeat ablation, hysterectomy • Risk from pre-existing conditions • Endometrial hyper-/neoplasia • Cesarean delivery •  Infection

Sharp AJOG 2012

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• Pregnancy-related complications ¡ Endometrial ablation is not contraception ¡  Increased risks:

§ Premature delivery § Morbidly adherent placenta § Uterine rupture § Cesarean delivery § Cesarean hysterectomy § Perinatal mortality

¡ Pregnancy can occur even in women with amenorrhea

Kohn BJOG 2018

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• Pain-related complications ¡ Amenorrhea 13-55%; 95% of pts have functional endometrium on MRI, even if

amenorrheic

¡ Post-ablation tubal sterilization syndrome (PATSS)

§ Difficult to target cornua with ablation § Visceral distension from menses obstruction

§ Treatment: salpingectomy < hysterectomy § Hysteroscopic sterilization

o Ablation scarring prevents adequate post-sterilization HSG, so recommendation is to wait until after 3 mo period before ablation

Sharp AJOG 2012; Turnbull BJOG 1997

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•  437 women followed median 2 yrs after ablation

•  21% developed pelvic pain ¡  46% went on to have hysterectomy

•  15% of total cohort: hysterectomy

¡  1/3 pain, 1/3 bleeding, 1/3 both

•  Risk factors for post-ablation pain ¡  Dysmenorrhea ¡  Age < 40 ¡  Tubal ligation ¡  Smokers


Original Article

Predicting Pelvic Pain After Endometrial Ablation: WhichPreoperative Patient Characteristics Are Associated?

May S. Thomassee, MD*, Howard Curlin, MD, Amanda Yunker, DO, MSCR, andTed L. Anderson, MD, PhDFrom the Division of Minimally Invasive Gynecologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee (all authors).

ABSTRACT Study Objective: To determine which patient characteristics are associated with an increased risk of postablation pelvic pain.Design: Canadian Task Force classification II-2.Methods: Data were collected from a retrospective cohort of patients who underwent endometrial ablation between January2006 and September 2010 at a large academic medical center. Patients were identified via Current Procedural Terminologycodes (58563, 58353, and 58356) for any type of endometrial ablation (rollerball or global); the sample size was 437 women.Multiple conditions and comorbidities were recorded for each patient. Bivariate analysis of patient demographics and the in-cidence of pain after endometrial ablation were evaluated using the chi square, Fisher exact, and independent t tests whereappropriate. A final multivariate analysis with logistic regression was conducted to determine the exact patient characteristicsthat are associated with pelvic pain after endometrial ablation.Results:Of 437 women who underwent endometrial ablation, 20.8% reported pain after their ablation. Patients were followedfor up to 6.5 years postablation with a median follow-up of 794 days. The median number of days for the development of painafter ablation was 301 days, with 75% of patients who developed pain reporting it within approximately 2 years of their pro-cedure. The median time to hysterectomy for those with pain was 570 days. Other postablation treatments included hormonaltherapies in 9.4% of the total population. A total of 20.8% of patients reported postablation pelvic pain, but only 6.3% un-derwent subsequent hysterectomy for that indication. Preablation patient characteristics significantly associated with the de-velopment of postablation pain include dysmenorrhea (aOR 5 1.73), smoking status (aOR 5 2.31), prior tubal ligation(aOR 5 1.68), and age less than 40 (aOR 1.90). Although not statistically significant, a diagnosis of endometriosis appearsto be related to postablation pain (aOR 5 2.24). Adenomyosis (suggested on ultrasound) and body mass index associationswere not statistically significant. A patient with all 4 risk factors for postablation pain (i.e., dysmenorrhea, smoking, prior tuballigation, and ,40 years old) has a 53% (95% confidence interval, 0.40–0.66) chance of experiencing postablation pain.Conclusion: The observed incidence of pelvic pain is 20.8% after endometrial ablation and is more frequently observed inwomen with preablation dysmenorrhea, tobacco use, prior tubal ligation, age less than 40, and possibly endometriosis. Oneshould consider these preexisting conditions when counseling patients regarding outcome expectations after an endometrialablation procedure. Journal of Minimally Invasive Gynecology (2013) -, -–- ! 2013 AAGL. All rights reserved.

Keywords: Endometrial ablation; Pelvic pain

DISCUSS You can discuss this article with its authors and with other AAGL members athttp://www.AAGL.org/jmig-20-6-JMIG-D-13-00026

Use your Smartphoneto scan this QR codeand connect to thediscussion forum forthis article now*

* Download a free QR Code scanner by searching for ‘‘QRscanner’’ in your smartphone’s app store or app marketplace.

Endometrial ablation is a commonly performed mini-mally invasive gynecologic procedure for the treatment ofabnormal uterine bleeding in the premenopausal patient.Its efficacy has been well established since the early1980s; however, a significant number of patients will failthis therapy and require a further procedure, most commonlyhysterectomy [1]. Analysis of large databases have reporteda subsequent failure rate of 16% at 5 years postablation,with failure defined as the need for repeat ablation or

The authors declare that they have no conflict of interest.Corresponding author: May S. Thomassee, MD, Department of Obstetricsand Gynecology, Vanderbilt University Medical Center, B-1100 MCN,Nashville, TN 37232-2519.E-mail: [email protected]

Submitted January 10, 2013. Accepted for publication April 12, 2013.Available at www.sciencedirect.com and www.jmig.org

1553-4650/$ - see front matter ! 2013 AAGL. All rights reserved.http://dx.doi.org/10.1016/j.jmig.2013.04.006

Thomassee JMIG 2012

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• 270 women after various NREAs • 23% developed new or worsening pelvic pain • 73% of those with new or worsening pain had preop fibroids or adenomyosis • 19% of total cohort: hysterectomy

¡ 30% pain, 26% bleeding, 20% both ¡ 3 hyperplaisa, 1 STUMP, 1 CA ¡ 2 hyperplasias missed on EMBx, one not done

• Risk factors for post-ablation pain ¡ Dysmenorrhea ¡ Tubal ligation ¡ Non-white race (?leiomyomas)

Differences between the populations were seen inBMI (P5.01), history of tubal sterilization (P5.01),and uterine mean size on imaging (P5.01).

Thermal balloon and bipolar radiofrequencywere used most often (Table 1). Of those ablationsdone in the office, most were bipolar radiofrequency(n527 [73%]) with the rest being thermal balloon(n510 [27%]). Conversely, for procedures in the oper-ating room, most were done by thermal balloon(n5117 [49.4%]) with bipolar radiofrequency for 99cases (39.8%). This difference was statistically signifi-cant (P5.004). For all patients, the most commonimaging finding was leiomyoma (n5104 [34.7%]) fol-lowed by no specific findings (n591 [30.3%]), sus-pected adenomyosis (n523 [7.7%]), both leiomyomaand adenomyosis (n517 [5.7%]), thickened endome-trial stripe (n510 [3.3%]), polyp (n58 [2.7%]), andleiomyoma and polyps (n52 [0.7%]). For 45 patients(15%), either no imaging was performed preopera-tively or a report was not available.

Overall, 62 (23.0%) patients developed worseningor new pain after ablation (Fig. 1). For six (9.7%) ofthese patients, either no imaging was performed aspart of the preoperative workup or the report wasnot available. Of those patients who had imaging,the most common findings were leiomyomas in 31(50.0%), no significant pathology in 14 (22.6%), ad-enomyosis in 13 (21.0%), and both leiomyomas andadenomyosis in six (9.7%). There were no significantdifferences in patient characteristics between patientswho developed pain and those who did not (Table 2).The relationship between developing pain and severalvariables is shown in Table 3. A history of dysmenor-rhea gave 74% higher risk of developing postablationpain (adjusted OR 1.74, 95% CI 1.06–2.87; P5.03) as

Table 1. Baseline Demographics of the StudyPopulation (N5300)

Demographic

PatientsWith NoFollow-up(n530)

Patients WithFollow-up(n5270) P

Age (y) 42.666.5 43.765.7 .29BMI (kg/m2) 36.067.4 31.068.2 .01Race

White 14 (47.0) 157 (58.1) .25Nonwhite 16 (53.0) 113 (41.9) .25

Parity 2.361.0 2.261.3 .68Dysmenorrhea 17 (57.0) 136 (50.4) .57Chronic pelvic pain 2 (6.7) 22 (8.1) 1.00Endometriosis 2 (6.7) 7 (2.6) .22Tubal sterilization 19 (63.0) 93 (34.4) .01Cesarean delivery 9 (30.0) 88 (32.6) .84Findings on imaging

Leiomyoma 9 (30.0) 107 (39.6) .33Adenomyosis 2 (6.7) 37 (13.7) .39

Uterine size (cm) 7.164.9 9.763.5 .01Ablation method

Thermal balloon 10 (33.0) 117 (43.3) .33Bipolar

radiofrequency17 (57.0) 109 (40.3) .12

Microwave 0 (0) 16 (5.9) .38Hydrothermal 1 (3.3) 11 (4.1) 1.00First generation 1 (3.3) 4 (1.5) .41

Ablation locationHospital 27 (90.0) 217 (80.4) .32Office* 3 (10.0) 35 (14.4) .78

BMI, body mass index.Data are as mean6standard deviation or n (%) unless otherwise

specified.* Done by either the thermal balloon or bipolar radiofrequency.

Fig. 1. Venn diagram showing selection of study population.Wishall. Postablation Pain and Hysterectomy. Obstet Gynecol 2014.

Table 2. Comparison of Patients With and WithoutPostablation Pain

Patient CharacteristicPain

(n562)No Pain(n5208) P

Age (y) 46.966.3 48.365.6 .05BMI (kg/m2) 31.769.1 30.567.9 .26Race

White 29 (46.8) 126 (60.6) .06Nonwhite 33 (53.2) 82 (39.4)

History of tubalsterilization

29 (46.8) 69 (33.2) .06

Parity 2.361.2 2.261.3 .66No. of cesarean deliveries 0.661 0.660.9 .60Endometrial stripe (mm) 9.865.7 8.765.6 .17

BMI, body mass index.Data are mean6standard deviation or n (%) unless otherwise specified.Independent t test was used.

906 Wishall et al Postablation Pain and Hysterectomy OBSTETRICS & GYNECOLOGY

Wishall Green J 2014

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• Pain is an Independent Risk Factor for Failed Global Endometrial Ablation • Cramer M et al, JMIG 2018 • 5800 women underwent ablation 2003-15 at Christiana • Overall 14% failure (some patients undoubtedly had care at other hospitals)

¡ 20% among patients with pelvic pain prior to ablation • Young age and pain independent risk factors for tx failure • Need to add reference to reference list

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True or False?

10% of women who undergo endometrial ablation will ultimately fail and require a hysterectomy

~20% ACOG Practice Bulletin Obstet Gynecol 2007/2018

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•  Treatment failure ¡  Risk factors

§  Age §  Parity ≥ 5 §  Prior sterilization §  Preop dysmenorrhea §  Ultrasound suggestive of adenomyosis §  Large uterine cavity

¡  Reasons for post-ablation hysterectomy §  Bleeding (51%), pain (28%), both(21%) §  Fibroids found in 44% of those with bleeding §  Hematometra found in 26% of those with pain

¡  Repeat ablation §  Uterine perforation, hemorrhage, excess fluid absorption, and genital tract burns (HTA)

higher risk in repeat ablation

Sharp AJOG 2012, Shazly JMIG 2016

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• Treatment failure • 500 patients • Avg followup 45 mos • 19% treatment failure • Risk factors

¡ Sterilization ¡ Dysmenorrhea ¡ Fibroids

• 5000 patients • 14% hysterectomy • Risk factors

¡ Age ¡ Pain

§ 19% hysterectomy among those with pain

Lybol JMIG 2018, Cramer JMIG 2018

a statistically significant difference in age between the 2groups of patients. The population with failed endome-trial ablation was statistically a younger cohort than theprevious subject group identified as satisfied. No otherdemographic parameters were statistically different.

Most patients included in this study had a thermal balloonablation technique for their endometrial ablation. Therewere 46 patients who had a thermal balloon ablation. Onepatient had a Novasure endometrial ablation. There were4 patients from outside institutions for whom we did nothave records of the types of their endometrial ablation.

The chief concern of patients who desired hysterectomyafter endometrial ablation was also noted (Figure 1). Of51 patients, menorrhagia was cited as the chief concern in22 patients (43%). Eleven patients (22%) noted pelvic painas their chief concern. Another group, 18 patients (27%),expressed concern about both pain and menorrhagia.

Of the 51 patients in the cohort studied, 92% (47 patients)underwent a hysterectomy by a laparoscopic approach:total laparoscopic hysterectomy, laparoscopic supracervi-cal hysterectomy, or laparoscopic assisted vaginal hyster-ectomy (Figure 2). A vaginal hysterectomy was per-formed in 4 of these patients. No patients underwent anabdominal hysterectomy. Therefore, most of our patientshad a laparoscopic pelvic evaluation.

We obtained both surgical and pathological diagnoses atthe time of hysterectomy. All patients had benign diagno-ses. Many patients had multiple benign diagnoses. Themost common diagnosis was endometriosis, which wasidentified in 35 patients or 69% of the cohort (Figure 3).These patients had either endometriosis alone or endo-metriosis in association with another benign diagnosis(Figure 4). Leiomyomata were present in 63% of patients

Figure 2. Type of hysterectomy: All hysterectomies were per-formed through a minimally invasive approach. Over 90% ofpatients had a laparoscopic evaluation of the pelvis. LAVH,laparoscopic assisted vaginal hysterectomy; LSH, laparoscopicsupracervical hysterectomy; TLH, total laparoscopic hysterec-tomy; TVH, total vaginal hysterectomy.

Figure 3. Pathology: Breakdown of benign gynecologic find-ings.

Figure 4. Pathology: Over two-thirds of patients in this studywere diagnosed with endometriosis. A ! F, adenomyosis andleiomyomata.

Figure 1. Presenting symptoms: Patient complaint at the time ofhysterectomy.

JSLS (2013)17:503–507 505

a statistically significant difference in age between the 2groups of patients. The population with failed endome-trial ablation was statistically a younger cohort than theprevious subject group identified as satisfied. No otherdemographic parameters were statistically different.

Most patients included in this study had a thermal balloonablation technique for their endometrial ablation. Therewere 46 patients who had a thermal balloon ablation. Onepatient had a Novasure endometrial ablation. There were4 patients from outside institutions for whom we did nothave records of the types of their endometrial ablation.

The chief concern of patients who desired hysterectomyafter endometrial ablation was also noted (Figure 1). Of51 patients, menorrhagia was cited as the chief concern in22 patients (43%). Eleven patients (22%) noted pelvic painas their chief concern. Another group, 18 patients (27%),expressed concern about both pain and menorrhagia.

Of the 51 patients in the cohort studied, 92% (47 patients)underwent a hysterectomy by a laparoscopic approach:total laparoscopic hysterectomy, laparoscopic supracervi-cal hysterectomy, or laparoscopic assisted vaginal hyster-ectomy (Figure 2). A vaginal hysterectomy was per-formed in 4 of these patients. No patients underwent anabdominal hysterectomy. Therefore, most of our patientshad a laparoscopic pelvic evaluation.

We obtained both surgical and pathological diagnoses atthe time of hysterectomy. All patients had benign diagno-ses. Many patients had multiple benign diagnoses. Themost common diagnosis was endometriosis, which wasidentified in 35 patients or 69% of the cohort (Figure 3).These patients had either endometriosis alone or endo-metriosis in association with another benign diagnosis(Figure 4). Leiomyomata were present in 63% of patients

Figure 2. Type of hysterectomy: All hysterectomies were per-formed through a minimally invasive approach. Over 90% ofpatients had a laparoscopic evaluation of the pelvis. LAVH,laparoscopic assisted vaginal hysterectomy; LSH, laparoscopicsupracervical hysterectomy; TLH, total laparoscopic hysterec-tomy; TVH, total vaginal hysterectomy.

Figure 3. Pathology: Breakdown of benign gynecologic find-ings.

Figure 4. Pathology: Over two-thirds of patients in this studywere diagnosed with endometriosis. A ! F, adenomyosis andleiomyomata.

Figure 1. Presenting symptoms: Patient complaint at the time ofhysterectomy.

JSLS (2013)17:503–507 505

Presenting sxs for hysterectomy Pathology from hysterectomy

• Compared 51 hysterectomy patients to 178 satisfied controls ¡ Age (39 vs 44, p<0.01) ¡ BTL (69% v 44%, p=0.06)


Characteristics of Patients Undergoing Hysterectomyfor Failed Endometrial Ablation

Kristin A. Riley, MD, Matthew F. Davies, MD, Gerald J. Harkins, MD

ABSTRACT

Background and Objectives: Endometrial ablation is aminimally invasive procedure for menorrhagia. High suc-cess rates are documented with !90% of patients experi-encing satisfaction. However, adequate relief after endo-metrial ablation is not obtained in a cohort of patients. Thepurpose of this study is to identify the characteristics ofpatients for whom endometrial ablation fails due to per-sistent symptoms, causing them to choose hysterectomyfor definitive treatment.

Methods: We conducted a retrospective chart review ofpatients who underwent hysterectomy for persistent men-orrhagia, pain, or both, who previously had endometrialablation. We reviewed medical records including pathol-ogy reports from hysterectomy. We compared demo-graphics to a group previously studied at our institutionthat were identified as satisfied 5 years after ablation.

Results: The number of patients in our study group was51 (n " 51). Median age of patients was 39 (range 29–50)years. Average body mass index was 31 (range 19–47)kg/m2. Average parity was 1.9. Sixty-nine percent under-went tubal ligation. The majority were nonsmokers (75%).Ninety-six percent were Caucasian. Compared with thepreviously studied satisfied group, the only statisticallysignificant difference was age.

Of 51 patients, 11 (22%) noted pelvic pain as their chiefconcern. Menorrhagia was the chief concern in 22 (43%).Eighteen patients (35%) complained of both. The mostcommon diagnosis was endometriosis, which was identi-fied in 35 patients (68%). Leiomyomata were present in 33patients (64%). Adenomyosis was identified in 22 patients(43%).

Conclusions: Patients who present for hysterectomy af-ter endometrial ablation have a high rate of endometriosis,adenomyosis, and leiomyomata, with endometriosis be-ing the most common finding.

Key Words: Endometrial ablation techniques, Endo-metriosis, Leiomyoma Hysterectomy.

INTRODUCTION

Menorrhagia is a common complaint that brings patientsto the gynecology office. Abnormal uterine bleeding cangreatly affect a patient’s life, causing discomfort and losttime from activities of daily living, including absence fromthe workplace. Previously, medical management and hys-terectomy were the only options for treatment of menor-rhagia. Since the 1980s, endometrial ablation has emergedas a minimally invasive treatment option. Many methodshave been used to accomplish endometrial ablation. En-dometrial resection, rollerball cautery, radiofrequency ab-lation, and thermal ablation have shown excellent suc-cess.1 The different techniques have limitations based onthe size and shape of the patient’s uterine cavity. How-ever, they have been shown to have similar efficacy with!90% satisfaction among treated patients. Compared withhysterectomy, endometrial ablation has a number of ad-vantages, including decreased operative time, decreasedrecovery time, and overall decreased cost.2

Success rates for endometrial ablation are high, with manystudies confirming up to 90% satisfaction.3 Many groupshave focused investigations on the successes and failuresof endometrial ablation to identify the appropriate patientpopulation for this intervention. Several possible risk fac-tors for failure of endometrial ablation have been identi-fied, including age, history of tubal ligation, and uterinesize.4–7

The purpose of this study is to identify common charac-teristics of patients who previously had undergone anendometrial ablation procedure as treatment for menor-rhagia and subsequently chose to undergo a hysterec-tomy. This retrospective chart review was undertaken toidentify patients in our population at risk for failure of

Department of Obstetrics and Gynecology, The Milton S. Hershey Medical Center,The Pennsylvania State College of Medicine, Hershey, PA, USA (all authors).

Financial disclosures: Dr. Harkins is a speaker/proctor for Intuitive and Ethicon. Dr.Davies is a speaker for Boston Scientific.

Address correspondence to: Kristin Riley, MD, 500 University Drive, P.O. Box 850,MC H103, Hershey, PA 17033. Telephone: 703-347-4405, Fax: 717-531-0066, E-mail:[email protected]

DOI: 10.4293/108680813X13693422520602

© 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published bythe Society of Laparoendoscopic Surgeons, Inc.

JSLS (2013)17:503–507 503

SCIENTIFIC PAPER

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Riley JSLS 2013

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Rates of treatment failure • 14,078 women • 20% subsequent hysterectomy

• 1169 women • 13% subsequent hysterectomy

Shavell JMIG 2012, Cooper BJOG 2011

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• Post-cesarean delivery ¡ GU injuries (bladder and ureteral fistulae)

reported ¡ Quantitative risk unknown

•  Infection ¡ Endometritis (1.4–2.0%) ¡ Myometritis (0–0.9%) ¡ PID (1.1%) ¡ TOA (0–1.1%) ¡ Endometrial destruction / necrosis thought to

be a risk factor different than simple hysteroscopy

Sharp AJOG 2012


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Soini Obstet Gynecol 2017; Dood JMIG 2014

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•  Patients at risk for hyperplasia / neoplasia ¡  Nulliparity, chronic anovulation, obesity, diabetes ¡  Tamoxifen tx, HNPCC, existing hyperplasia (contraindications)

•  Ablation might mask the symptom that makes EMCA early diagnosis •  Endometrial sampling post-ablation

¡  What is abnormal bleeding after an ablation? ¡  Don’t know the utility of office biopsy after ablation ¡  Office biopsy only samples 4% of the endometrium ¡  U/S EM thickness not reliable after ablation ¡  Probably obligated to do hysteroscopic bx / D&C ¡  Post-ablation hysteroscopy can be challenging ¡  May require hysterectomy

§  (at a time when they were likely less healthy than ablation) ¡  If cancer present, then additional procedures indicated

Rodriguez AJOG 1993

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• 16 patients s/p ablation undergoing hysterectomy

•  -EMB insufficient 50% of the time •  -D&C insufficient 73% of the time

•  -EMB agreed with hysterectomy only 27% of the time •  -D&C agreed with hysterectomy only 20% of the time


Pierce JMIG 2015

Comparisons among treatments

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¡ Hysterectomy associated with highest satisfaction and most cost-effective

(despite low numbers of TLH)

Bhattacharya Health Technol Assess 2011

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•  9 RCTs reviewed ¡  Some studies: better SF-36 for pain, vitality, general health, social function w/hysterectomy ¡  Most studies: no statistical difference in satisfaction (one favored hysterectomy) ¡  One study: 73% (hyst) vs 48% (ablation) “health much better” compared w 1year ago ¡  Hysterectomy superior for dysmenorrhea ¡  Pelvic pain: 18-64% ablation vs. 5-19% hysterectomy ¡  2-19% of ablation patients underwent repeat ablation; 10-29% underwent hysterectomy ¡  Similar results comparing hysterectomy to LNG-IUS ¡  Very small numbers of laparoscopic hysterectomy

Review Article

A Systematic Review Comparing Hysterectomy with Less-InvasiveTreatments for Abnormal Uterine Bleeding

Kristen A. Matteson, MD, MPH*, Husam Abed, MD, Thomas L. Wheeler, II, MD, MSPH,Vivian W. Sung, MD, MPH, David D. Rahn, MD, Joseph I. Schaffer, MD, andEthan M. Balk, MD, MPH, for the Society of Gynecologic Surgeons Systematic Review GroupFrom the Women and Infants Hospital, The Warren Alpert Medical School of Brown University, Providence, Rhode Island (Drs. Matteson and Sung), HenryFord Health System, Detroit, Michigan (Dr. Abed), University Medical Group, Greenville Hospital Systems, Greenville, South Carolina (Dr. Wheeler),University of Texas Southwestern Medical Center, Dallas, Texas (Drs. Rahn and Schaffer), and Tufts University School of Medicine, Tufts Medical Center,Boston, Massachusetts (Dr. Balk).

ABSTRACT Study Objective: To compare hysterectomy with less-invasive alternatives for abnormal uterine bleeding (AUB) in 7 clini-cally important domains.Design: Systematic review.Setting: Randomized clinical trials comparing bleeding, quality of life, pain, sexual health, satisfaction, need for subsequentsurgery, and adverse events between hysterectomy and less-invasive treatment options.Patients: Women with AUB, predominantly from ovulatory disorders and endometrial causes.Interventions: Systematic review of the literature (from inception to January 2011) comparing hysterectomy with alterna-tives for AUB treatment. Eligible trials were extracted into standardized forms. Trials were graded with a predefined3-level rating, and the strengths of evidence for each outcome were evaluated with the Grades for Recommendation, Assess-ment, Development and Evaluation system.Measurements andMain Results:Nine randomized clinical trials (18 articles) were eligible. Endometrial ablation, levonor-gestrel intrauterine system, and medications were associated with lower risk of adverse events but higher risk of additionaltreatments than hysterectomy. Compared to ablation, hysterectomy had superior long-term pain and bleeding control.Compared with the levonorgestrel intrauterine system, hysterectomy had superior control of bleeding. No otherdifferences between treatments were found.Conclusion: Less-invasive treatment options for AUB result in improvement in quality of life but carry significant risk of re-treatment caused by unsatisfactory results. Although hysterectomy is the most effective treatment for AUB, it carries the high-est risk for adverse events. Journal of Minimally Invasive Gynecology (2012) 19, 13–28 ! 2012 AAGL. All rights reserved.

Keywords: Abnormal uterine bleeding; Dysfunctional uterine bleeding; Hysterectomy; Systematic review

DISCUSS You can discuss this article with its authors and with other AAGL members athttp://www.AAGL.org/jmig-19-1-11-00283

Use your Smartphoneto scan this QR codeand connect to thediscussion forum forthis article now*

* Download a free QR Code scanner by searching for ‘‘QRscanner’’ in your smartphone’s app store or app marketplace.

Abnormal uterine bleeding (AUB) affects up to 30% ofwomen during their reproductive years [1–4]. AUB hasa substantial impact on women’s quality of life, associated

loss of productivity, and major health care costs [5–8]. AUBis a symptom of several different underlying conditions,which have been newly classified by the International

All authors have no conflicts of interest to report.Supported by the Society of Gynecologic Surgeons, who provided ad-ministrative and financial support for the Systematic Review Group’s meet-ings and consultants (www.sgsonline.org). Other support: Dr. Mattesonis supported by K23HD057957, and Dr. Vivian Sung is supported byK23HD060665 (both grants from the National Institutes of Health, NationalInstitute of Child Health and Human Development).

Corresponding author: Kristen A. Matteson, MD, MPH, Department of Ob-stetrics and Gynecology, Women & Infants Hospital, 101 Dudley Street,Providence, RI 02905.E-mail: [email protected]

Submitted June 15, 2011. Accepted for publication August 12, 2011.Available at www.sciencedirect.com and www.jmig.org

1553-4650/$ - see front matter ! 2012 AAGL. All rights reserved.doi:10.1016/j.jmig.2011.08.005

Matteson JMIG 2012

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• RCT of LSH vs Hysteroscopic endometrial ablation for abnl uterine bleeding ¡  Initial trial: 1995-1997, 203 randomized patients

§ Two-year outcomes favored LSH § No difference in hospitalization, complications, resumption of activities

¡ Higher reoperation rate with HEA (13% vs 1%), greater satisfaction LSH ¡ Contacted patients 15 years later ¡ Results

§ 153 subjects § Reoperation rate: 28% vs 0% § All HEA patients initially received repeat ablation, 75% of those went on to have hysterectomy § Hysterectomy: higher mental and physical scores on SF-12

Zupi JMIG 2015

Reviews

Levonorgestrel-Releasing Intrauterine Systemand Endometrial Ablation in Heavy MenstrualBleedingA Systematic Review and Meta-Analysis

Andrew M. Kaunitz, MD, Susanna Meredith, MD, Pirjo Inki, MD, PhD, Ali Kubba, MD,and Luis Sanchez-Ramos, MD

OBJECTIVE: To compare the effects of the levonorg-estrel intrauterine system and endometrial ablation inreducing heavy menstrual bleeding.

DATA SOURCES: Medline and EMBASE were searchedonline using Ovid up to January 2009, as well as thereference lists of published articles, to identify random-ized controlled trials comparing the levonorgestrel intra-uterine system with endometrial ablation in the treat-ment of heavy menstrual bleeding.

METHODS OF STUDY SELECTION: This systematic re-view and meta-analysis was restricted to randomizedcontrolled trials in which menstrual blood loss was re-ported using pictorial blood loss assessment chart scores.

TABULATION, INTEGRATION, AND RESULTS: Six ran-domized controlled trials that included 390 women(levonorgestrel intrauterine system, n!196; endometrialablation, n!194) were retrieved. Three studies pertained

to first-generation endometrial ablation (manual hyster-oscopy) and three to second-generation endometrialablation (thermal balloon). Study characteristics andquality were recorded for each study. Data on the effectof treatment on pictorial blood loss assessment chartscores were abstracted, integrated with meta-analysistechniques, and presented as weighted mean differences.Both treatment modalities were associated with similarreductions in menstrual blood loss after 6 months(weighted mean difference, –31.96 pictorial blood lossassessment chart score [95% confidence interval (CI),–65.96 to 2.04]), 12 months (weighted mean difference,7.45 pictorial blood loss assessment chart score [95% CI,–12.37 to 27.26]), and 24 months (weighted mean differ-ence, –26.70 pictorial blood loss assessment chart score[95% CI, –78.54 to 25.15]). In addition, both treatmentswere generally associated with similar improvements inquality of life in five studies that reported this as anoutcome. No major complications occurred with eithertreatment modality in these small trials.

CONCLUSION: Based on the meta-analysis of six ran-domized clinical trials, the efficacy of the levonorgestrelintrauterine system in the management of heavy men-strual bleeding appears to have similar therapeutic effectsto that of endometrial ablation up to 2 years aftertreatment.(Obstet Gynecol 2009;113:1104–16)

Menorrhagia or heavy menstrual bleeding is acommon gynecologic problem that constitutes

a frequent indication for surgical intervention. Tradi-tionally, the most common surgical treatment forheavy menstrual bleeding has been hysterectomy.Hysterectomy results in complete cessation of men-strual bleeding and is associated with high levels ofsatisfaction. However, it may not be the most appro-priate method for some women, especially those who

From the Department of Obstetrics and Gynecology, University of FloridaCollege of Medicine-Jacksonville, Florida; Bayer Schering Pharma AG, Berlin,Germany; and Department of Obstetrics and Gynaecology, Guys, Kings & StThomas’ School of Medicine, London, United Kingdom.

Corresponding author: Andrew M. Kaunitz, MD, Department of Obstetrics andGynecology, University of Florida College of Medicine-Jacksonville, Jacksonville,FL 32209; e-mail: [email protected].

Editorial assistance for the development of this manuscript was provided byRichard Glover, with the financial support of Bayer Schering Pharma AG.

Financial DisclosureDr. Kaunitz has been a consultant to Bayer Schering Pharma AG (Berlin,Germany), the manufacturer of the levonorgestrel-releasing intrauterine system.Dr. Inki is an employee of Bayer Schering Pharma AG. Dr. Kubba hasperformed ad hoc lecturing or consulting work for Bayer Schering Pharma AG.Drs. Kaunitz and Kubba have been on scientific advisory boards for BayerSchering Pharma AG. The Department of Obstetrics and Gynecology of theUniversity of Florida College of Medicine-Jacksonville receives financial supportfrom Bayer Schering Pharma AG for conducting clinical trials. The other authorsdid not report any potential conflicts of interest.

© 2009 by The American College of Obstetricians and Gynecologists. Publishedby Lippincott Williams & Wilkins.ISSN: 0029-7844/09

1104 VOL. 113, NO. 5, MAY 2009 OBSTETRICS & GYNECOLOGY

dalities in the studies included in our meta-analysis:11% (21/196) and 10% (19/194) for the LNG-IUS andendometrial ablation, respectively. Because there are,

to the best knowledge of the authors, no 5-yearfollow-up results available from randomized trialsdirectly comparing the two treatment modalities, it is

–30.00 (–72.58 to 12.58) 63.8

–35.40 (–91.89 to 21.09) 36.2

–31.96 (–65.96 to 2.04)

Barrington et al. 2003

Busfield et al. 2006

Overall (95% CI)

–50 –30 –10 0 10 30 50A

–1.60 (–17.04 to 13.84) 21.8

7.45 (–12.37 to 27.26)

Malak and Shawki 2006

–53.60 (–98.76 to –8.44) 10.9Busfield et al. 2006

15.30 (–1.20 to 31.80) 21.4Crosignani et al. 1997

33.20 (27.07 to 39.33) 24.5Soysal et al. 2002

10.40 (–5.75 to 26.55) 21.5Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50B

Weighted mean difference

Favors the levonorgestrel-releasing system

Favors endometrial ablation

–26.70 (–78.54 to 25.15)

–54.80 (–88.18 to –21.42) 47.0Busfield et al. 2006

–1.80 (–23.30 to 19.70) 53.0Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50

C

Weighted mean difference(95% CI)

Weight (%)

Fig. 2. Comparison of the levonorgestrel-releasing intrauterine system with endometrial ablation on menstrual blood loss:6 months (A), 12 months (B), and 24 months (C). Each study is represented by a black square and a horizontal line whichcorresponds to the point estimate and the 95% confidence intervals (CIs). The solid vertical line corresponds to no differencebetween treatments. If the CI includes 0, then the difference in the effect of levonorgestrel-releasing intrauterine system andendometrial ablation is not statistically significant at the conventional level (P!.05). The area of black squares reflects theweight of the study in the meta-analysis. If the black square and accompanying 95% CIs are to the left of the solid verticalline, then the levonorgestrel-releasing intrauterine system significantly lowered pictorial blood loss assessment chart scorescompared with endometrial ablation; however, if the black square and 95% CIs are to the right of the solid vertical line, thenendometrial ablation significantly lowered pictorial bleeding assessment chart scores compared with the levonorgestrel-releasing intrauterine system. The overall estimate and CI are marked by a trapezoid (diamond). If the trapezoid overlaps thevertical solid line, this indicates that there is no statistically significant difference in the amount of bleeding betweenlevonorgestrel-releasing intrauterine system and endometrial ablation.Kaunitz. Levonorgestrel System or Endometrial Ablation. Obstet Gynecol 2009.

VOL. 113, NO. 5, MAY 2009 Kaunitz et al Levonorgestrel System or Endometrial Ablation 1113



–30.00 (–72.58 to 12.58) 63.8

–35.40 (–91.89 to 21.09) 36.2

–31.96 (–65.96 to 2.04)



Overall (95% CI)

–50 –30 –10 0 10 30 50A

–1.60 (–17.04 to 13.84) 21.8

7.45 (–12.37 to 27.26)


–53.60 (–98.76 to –8.44) 10.9Busfield et al. 2006


33.20 (27.07 to 39.33) 24.5Soysal et al. 2002

10.40 (–5.75 to 26.55) 21.5Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50B




–26.70 (–78.54 to 25.15)

–54.80 (–88.18 to –21.42) 47.0Busfield et al. 2006

–1.80 (–23.30 to 19.70) 53.0Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50

C


Weight (%)





–30.00 (–72.58 to 12.58) 63.8

–35.40 (–91.89 to 21.09) 36.2

–31.96 (–65.96 to 2.04)



Overall (95% CI)

–50 –30 –10 0 10 30 50A

–1.60 (–17.04 to 13.84) 21.8

7.45 (–12.37 to 27.26)


–53.60 (–98.76 to –8.44) 10.9Busfield et al. 2006


33.20 (27.07 to 39.33) 24.5Soysal et al. 2002

10.40 (–5.75 to 26.55) 21.5Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50B




–26.70 (–78.54 to 25.15)

–54.80 (–88.18 to –21.42) 47.0Busfield et al. 2006

–1.80 (–23.30 to 19.70) 53.0Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50

C


Weight (%)





–30.00 (–72.58 to 12.58) 63.8

–35.40 (–91.89 to 21.09) 36.2

–31.96 (–65.96 to 2.04)



Overall (95% CI)

–50 –30 –10 0 10 30 50A

–1.60 (–17.04 to 13.84) 21.8

7.45 (–12.37 to 27.26)


–53.60 (–98.76 to –8.44) 10.9Busfield et al. 2006


33.20 (27.07 to 39.33) 24.5Soysal et al. 2002

10.40 (–5.75 to 26.55) 21.5Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50B




–26.70 (–78.54 to 25.15)

–54.80 (–88.18 to –21.42) 47.0Busfield et al. 2006

–1.80 (–23.30 to 19.70) 53.0Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50

C


Weight (%)





–30.00 (–72.58 to 12.58) 63.8

–35.40 (–91.89 to 21.09) 36.2

–31.96 (–65.96 to 2.04)



Overall (95% CI)

–50 –30 –10 0 10 30 50A

–1.60 (–17.04 to 13.84) 21.8

7.45 (–12.37 to 27.26)


–53.60 (–98.76 to –8.44) 10.9Busfield et al. 2006


33.20 (27.07 to 39.33) 24.5Soysal et al. 2002

10.40 (–5.75 to 26.55) 21.5Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50B




–26.70 (–78.54 to 25.15)

–54.80 (–88.18 to –21.42) 47.0Busfield et al. 2006

–1.80 (–23.30 to 19.70) 53.0Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50

C


Weight (%)





–30.00 (–72.58 to 12.58) 63.8

–35.40 (–91.89 to 21.09) 36.2

–31.96 (–65.96 to 2.04)



Overall (95% CI)

–50 –30 –10 0 10 30 50A

–1.60 (–17.04 to 13.84) 21.8

7.45 (–12.37 to 27.26)


–53.60 (–98.76 to –8.44) 10.9Busfield et al. 2006


33.20 (27.07 to 39.33) 24.5Soysal et al. 2002

10.40 (–5.75 to 26.55) 21.5Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50B




–26.70 (–78.54 to 25.15)

–54.80 (–88.18 to –21.42) 47.0Busfield et al. 2006

–1.80 (–23.30 to 19.70) 53.0Rauramo et al. 2004

Overall (95% CI)

–50 –30 –10 0 10 30 50

C


Weight (%)



•  6 RCTs •  No difference in HMB or quality of life improvements •  Ablation assoc w higher risk of perioperative and long-term complications

37

Kaunitz Obstet and Gynecol 2009

6 mos 12 mos 24 mos

• Hysterectomy more common w ablation ¡  (24% vs 4%, p=0.04)

• Hgb higher in LNG-IUS grp ¡  (14.1 vs 12.7, p=0.01)

• Bleeding profile favors LNG-IUS • Patient ratings higher LNG-IUS

¡ Acceptability ¡ Perceived clinical improvement ¡ Overall satisfaction

Original research article

Five-year follow-up of levonorgestrel-releasing intrauterine system versusthermal balloon ablation for the treatment of heavy menstrual bleeding:

a randomized controlled trial☆,☆☆

Agnaldo L. Silva-Filho⁎, Francisco de A.N. Pereira, Sérgio S. de Souza,Luciano F. Loures, Ana Paula C. Rocha, Carolina N. Valadares,Márcia M. Carneiro, Rubens L.C. Tavares, Aroldo F. Camargos

Department of Gynecology and Obstetrics, School of Medicine, Federal University of Minas Gerais, Minas Gerais 31.030-100, BrazilReceived 14 May 2012; revised 2 November 2012; accepted 3 November 2012

Abstract

Background: The study was conducted to compare 5-year follow-up of levonorgestrel-releasing intrauterine system (LNG-IUS) or thermalballoon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB).Study Design: A prospective, randomized controlled trial comparing LNG-IUS (n=30) and TBA (n=28) was performed. Hysterectomy rates,hemoglobin level, bleeding pattern, well-being status and satisfaction rates were assessed. Comparisons between groups were performed by!2 test and by unpaired and paired t tests.Results: After 5 years of follow-up, women treated with a TBA had higher rates of hysterectomy (24%) compared to the LNG-IUS group(3.7%) due to treatment failure (p=.039). Use of LNG-IUS resulted in higher mean hemoglobin (±SD) levels in comparison to the TBAgroup (14.1±0.3 vs 12.7±0.4 g/dL, p=.009). Menstrual blood loss was significantly higher in the TBA when compared to the LNG-IUS group(45.5% vs 0.0% pb.001). The psychological general well-being index scores were similar. Patient acceptability, perceived clinicalimprovement and overall satisfaction rates were significantly higher in women using LNG-IUS.Conclusion: Five-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratingscompared to TBA.© 2013 Elsevier Inc. All rights reserved.

Keywords: Heavy menstrual bleeding; Thermal balloon ablation; Thermal balloon; Levonorgestrel intrauterine system; Endometrium

1. Introduction

Heavy menstrual bleeding (HMB) is defined as excessivemenstrual blood loss which interferes with the woman'sphysical, emotional, social and material quality of life, andwhich can occur alone or in combination with othersymptoms [1]. HMB causes 1 in 20 women of reproductiveage to seek medical care, accounts for 20% of all referrals togynecology outpatients departments [2] and is the most

common cause of iron deficiency anemia in healthy fertilewomen [3].

HMB is an important health issue for women as it cancause considerable distress by adversely affecting theirperformance at work as well as social activities and leads to aconsiderable reduction in the health-related quality of life(HRQOL) measures [4–6]. A community-based cross-sectional study conducted in southern Brazil of 18–45-year-old women showed a prevalence of HMB in 35.3% ofthis population [7].

First-line treatments for HMB include oral drug regimenssuch as tranexamic acid, mefenamic acid and the combinedoral contraceptive. More recently, an alternative medicaloption is the levonorgestrel intrauterine system (LNG-IUS,Mirena™), a contraceptive device that can reduce menstrualloss through local release of progestogen.

Contraception 87 (2013) 409–415

☆ Disclosure: None of the authors have conflicts of interest.☆☆ Financial support: The materials (Gynecare Thermachoice

Uterine Balloon Therapy System and Mirena®) used in this study weresupplied by Bayer.

⁎ Corresponding author. Tel.: +55 31 3409 9764; fax: +55 31 3409 9765.E-mail address: [email protected] (A.L. Silva-Filho).

0010-7824/$ – see front matter © 2013 Elsevier Inc. All rights reserved.http://dx.doi.org/10.1016/j.contraception.2012.11.004

significantly higher rates of hysterectomy compared to thosein the LNG-IUS group (p=.039).

Of the 30 patients initially randomized for treatment withLNG-IUS, 3 were lost to follow-up, 1 had a hysterectomydue to treatment failure, and 9 became menopausal, so 17patients were evaluated for hemoglobin levels, PGWBIscores and bleeding pattern. In the same way, the TBA grouphad 28 patients initially, but 3 were lost to follow-up, 6 hadhysterectomy due to treatment failure, and 8 becamemenopausal, leaving a group of 11 patients for thehemoglobin, PGWBI and bleeding pattern analysis.

3.3. Hemoglobin levels

Treatment with LNG-IUS resulted in higher meanhemoglobin (±SD) levels at the 5-year analysis (Fig. 3)compared with those in the TBA group (14.1±0.3 vs. 12.7±0.4 g/dL, p=.009). In the LNG-IUS group, there was anincrease in the mean hemoglobin (±SD) levels compared tobaseline (12.5±0.3 vs. 14.41±0.3 g/dL, p=.0056). In the TBAgroup, the mean hemoglobin (±SD) levels after 5 years weresimilar to the baseline values (12.7±0.4 vs. 12.3±0.4 g/dL,p=.682).

3.4. Psychological general well-being index

There was no significant difference in the mean PGWBI(±SD) scores at the end of the 5th year of follow-up (LNG-IUS 100.4±5.8 vs. TBA 90.1±6.1, p=.247) (Fig. 4). ThePGWBI (±SD) scores were similar before and 5 years aftertreatment in both groups (LNG-IUS 88.5±3.8 vs. 100.4±5.8,p=.103, and TBA 85.9±6.9 vs. 90.1±6.1, p=.602).

3.5. Bleeding pattern

The LNG-IUS was associated with less MBL after 5 yearscompared to TBA (pb.001). In the TBA group, 45.5% of thepatients presented with increased MBL at 5 years, and nonepresented with amenorrhea 5 years after its insertion.Conversely, in the LNG-IUS group, none of the patientshad increased MBL, and 35.3% patients presented withamenorrhea. No significant differences were observed in theintermenstrual bleeding pattern between the two treatmentgroups (p=.458) (Fig. 5).

3.6. Satisfaction rates

Patient acceptability, perceived clinical improvement andoverall satisfaction rate were significantly higher in womenusing the LNG-IUS compared to those having a TBA after 5years of treatment (Fig. 6). To the statement “I feel much betterafter treatment,” the answers “Definitely agree” and “Some-what agree”were reported by 100% in the LNG-IUS group vs.72% in the TBA group (p=.009). To the statement “I am very

Fig. 3. Evaluation of mean hemoglobin levels in patients with heavy uterinebleeding before and 5 years after treatment with the LNG-IUS (n=17) orTBA (n=11). Comparison between the two groups was performed usingnonpaired Student's t test, and comparison before and after treatment wasperformed using paired Student's t test.

Fig. 4. Evaluation of mean PGWBI in patients with HMB before and 5 yearsafter treatmentwith theLNG-IUS (n=17) or TBA (n=11). Comparison betweenthe two groupswas performed using nonpaired Student's t test, and comparisonbefore and after treatment was performed using paired Student's t test.

Fig. 5. Evaluation of menstrual (A) and intermenstrual (B) bleeding patternsin the 5th year in women with HMB treated with the LNG-IUS (n=17) orTBA (n=11). Comparison between the two groups was performed using the!2 test.

412 A.L. Silva-Filho et al. / Contraception 87 (2013) 409–415

significantly higher rates of hysterectomy compared to thosein the LNG-IUS group (p=.039).

Of the 30 patients initially randomized for treatment withLNG-IUS, 3 were lost to follow-up, 1 had a hysterectomydue to treatment failure, and 9 became menopausal, so 17patients were evaluated for hemoglobin levels, PGWBIscores and bleeding pattern. In the same way, the TBA grouphad 28 patients initially, but 3 were lost to follow-up, 6 hadhysterectomy due to treatment failure, and 8 becamemenopausal, leaving a group of 11 patients for thehemoglobin, PGWBI and bleeding pattern analysis.

3.3. Hemoglobin levels

Treatment with LNG-IUS resulted in higher meanhemoglobin (±SD) levels at the 5-year analysis (Fig. 3)compared with those in the TBA group (14.1±0.3 vs. 12.7±0.4 g/dL, p=.009). In the LNG-IUS group, there was anincrease in the mean hemoglobin (±SD) levels compared tobaseline (12.5±0.3 vs. 14.41±0.3 g/dL, p=.0056). In the TBAgroup, the mean hemoglobin (±SD) levels after 5 years weresimilar to the baseline values (12.7±0.4 vs. 12.3±0.4 g/dL,p=.682).

3.4. Psychological general well-being index

There was no significant difference in the mean PGWBI(±SD) scores at the end of the 5th year of follow-up (LNG-IUS 100.4±5.8 vs. TBA 90.1±6.1, p=.247) (Fig. 4). ThePGWBI (±SD) scores were similar before and 5 years aftertreatment in both groups (LNG-IUS 88.5±3.8 vs. 100.4±5.8,p=.103, and TBA 85.9±6.9 vs. 90.1±6.1, p=.602).

3.5. Bleeding pattern

The LNG-IUS was associated with less MBL after 5 yearscompared to TBA (pb.001). In the TBA group, 45.5% of thepatients presented with increased MBL at 5 years, and nonepresented with amenorrhea 5 years after its insertion.Conversely, in the LNG-IUS group, none of the patientshad increased MBL, and 35.3% patients presented withamenorrhea. No significant differences were observed in theintermenstrual bleeding pattern between the two treatmentgroups (p=.458) (Fig. 5).

3.6. Satisfaction rates

Patient acceptability, perceived clinical improvement andoverall satisfaction rate were significantly higher in womenusing the LNG-IUS compared to those having a TBA after 5years of treatment (Fig. 6). To the statement “I feel much betterafter treatment,” the answers “Definitely agree” and “Some-what agree”were reported by 100% in the LNG-IUS group vs.72% in the TBA group (p=.009). To the statement “I am very

Fig. 3. Evaluation of mean hemoglobin levels in patients with heavy uterinebleeding before and 5 years after treatment with the LNG-IUS (n=17) orTBA (n=11). Comparison between the two groups was performed usingnonpaired Student's t test, and comparison before and after treatment wasperformed using paired Student's t test.

Fig. 4. Evaluation of mean PGWBI in patients with HMB before and 5 yearsafter treatmentwith theLNG-IUS (n=17) or TBA (n=11). Comparison betweenthe two groupswas performed using nonpaired Student's t test, and comparisonbefore and after treatment was performed using paired Student's t test.

Fig. 5. Evaluation of menstrual (A) and intermenstrual (B) bleeding patternsin the 5th year in women with HMB treated with the LNG-IUS (n=17) orTBA (n=11). Comparison between the two groups was performed using the!2 test.

412 A.L. Silva-Filho et al. / Contraception 87 (2013) 409–415

38

Silva-Filho Contraception 2013

40


• LNG-IUS resulted in the most QALYs over the model’s 5-year horizon • Ablation had more treatment failures and complications than hysterectomy • LNG-IUS most cost effective • Hysterectomy associated with greater quality of life than either type of ablation, but at a higher

cost Louie IJOG 2017; Spencer AJOG 2017

41

Endometrial Abla<on LNG-‐IUS Hysterectomy

Cancer No protec<on Temporary protec<on Permanent protec<on

Dysmenorrhea Risk for failure Improves Defini<ve treatment

Contracep<on No Yes Yes

Future pregnancy No Yes No

In-‐office Yes Yes No

Procedure cost Middle Least expensive Most expensive

Reimbursement Best Least Middle

Procedure risk Middle Least Most

Cost-‐effec<veness Least Most Middle

Endometrial sampling Problema<c Yes Not needed

Return to ac<vi<es Middle Fastest Slowest

Hormonal side effects No Yes No

42

Special populations

• Submucosal myomas ¡ HSC or LSC

myomectomy

• Pelvic pain ¡ Risk factor for treatment

failure ¡ Post-ablation post-tubal

ligation syndrome

• Differently abled ¡ Age most consistent significant risk

factor for ablation failure ¡ Ablation is not contraception &

pregnancy post-ablation assoc w/ risk ¡ Ablation can be difficult in small

nulligravid uteri

43

Supracervical hysterectomy

• History ¡ 1st hysterectomy: vaginal, 1813 (Conrad Langenbeck) ¡ 1st abdominal hysterectomy: supracervical, 1863 (Charles Clay) ¡ 1st total hysterectomy: 1929 (EH Richardson) ¡ Laparoscopyà increased numbers of supracervicals

§ Rates approach 50% in certain parts of Scandanavia § 7.5% in the US, 20% in California

44


• Postulated reasons to retain cervix: ¡ Avoid vaginal shortening ¡ Prevent prolapse ¡ Preserve urinary, bowel function ¡ Preserve sexual functioning ¡ Avoid poor cuff healing or fallopian tube prolapse ¡ Faster operation, less complications

45

Supracervical Hysterectomy

• 9 randomized trials, 1553 subjects • Updates from 2006 Cochrane review:

¡ Six new trials ¡ Twice as many subjects ¡  Included long-term (>5 years) followup ¡ Stratified by open or LSC approach for short-term

outcomes

Total versus subtotal hysterectomy for benign gynaecologicalconditions (Review)

Lethaby A, Mukhopadhyay A, Naik R

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2012, Issue 4

http://www.thecochranelibrary.com

Total versus subtotal hysterectomy for benign gynaecological conditions (Review)

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Lethaby Cochrane 2012

46

•  Primary outcomes ¡  Urinary function

§  Stress incontinence §  Urinary urgency §  Voiding dysfunction (incomplete emptying

¡  Bowel function §  Constipation §  Incontinence (stool)

¡  Sexual function §  Pain symptoms or dyspareunia §  Satisfaction, relationship and functioning

combined

•  Secondary outcomes

¡  Quality of life (validated scales) ¡  Operating time ¡  Recovery from surgery ¡  Length of hospital stay ¡  Return to normal activities ¡  Short term complications (pre-discharge)

§  Surgical injury §  EBL, blood transfusion §  Pelvic hematoma §  Vaginal bleeding §  UTI or other infection, fever §  Urinary retention or bowel obstruction



47


• Secondary outcomes (continued) ¡  Intermediate complications (up to two years post-surgery)

§ Ongoing cyclical bleeding § Persistent pain § Need for removal of cervical stump § Pelvic organ prolapse § Gynecologic cancer

• Long term complications (> two years post-surgery) ¡ Fistulae ¡ Pelvic organ prolapse ¡ Gynecologic cancer


48


• Urinary function ¡ No difference in incontinence,

incomplete emptying or urinary urgency

¡ Both short-term and long-term ¡ Both open and laparoscopic

• Bowel function ¡ No difference in constipation or

incontinence ¡ Both short-term and long-term

(incontinence) ¡ No LSC studies

• Sexual function ¡ No difference in sexual satisfaction ¡ No difference in dyspareunia ¡ Both short-term and long-term ¡ Both open and laparoscopic

• Quality of life ¡ Subjects reported improved quality of

life, regardless of type of hysterectomy (no differences)


49


•  Operation time ¡  TAH 11 min longer than open SCH ¡  No difference between TLH and LSH

•  Recovery ¡  No difference in hospital stay ¡  No difference in resumption of normal activities

•  Blood loss ¡  TAH 57mL greater than open SCH for EBL ¡  No difference between TLH and LSH ¡  No difference in transfusion rate, open or LSC

•  Fever and urinary retention ¡  More common TAH vs open SCH

•  Other complications ¡  No differences: surgical injury, hematoma, vaginal

bleeding, wound infection, or bowel obstruction, readmission rate

•  Intermediate outcomes

¡  Cyclic bleeding higher in SCH ¡  No differences: persistent pain, prolapse, trachelectomy

or GYN cancer (rare outcomes)

•  Long-term outcomes ¡  No difference: prolapse, alleviation of preop sxs ¡  Not enough data for GYN cancer


50


Risks of supracervical hysterectomy • Cyclic bleeding (up to 11%)

¡ Especially for those with h/o “fundectomy” • Cervix dysplasia or neoplasia • Endometrial cancer

¡ 23% of trachelectomy specimens with residual endometrium

¡ Combined HRT in menopause • Need for future surgery (up to 24%)

¡ Bleeding, cervical allodynia, residual endometriosis

• Morcellation

Risks of total hysterectomy • Delayed resumption of penetration intercourse

• Vaginal cuff dehiscence


51


• Contraindications/special populations ¡ Precancerous/cancerous conditions of the cervix, smoking ¡ Endometriosis ¡ Pelvic pain ¡ Obesity

§  Increases surgical risk § Higher risk for endometrial cancer

52


• Counseling (US east coast, 2003) ¡ 45% OBGYNs always perform total ¡ 18% counsel about advantages / disadvantages ¡ 63% rarely or never counseled about advantages / disadvantages ¡ 19% always offered a choice ¡ 61% rarely or never offered a choice ¡ Of those that offered SCH

§ 36% believed SCH offered benefits such as protection against prolapse § 28% would perform SCH despite abnormal pap history

• ACOG: ¡  “The supracervical approach should not be recommended by the surgeon as a

superior technique for hysterectomy for benign disease.”

Zekam Green J 2003; ACOG Green J 2007/2010 (withdrawn)

Laparoscopic trachelectomy

53

54

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