Salpingo(s)tomy vs salpingectomyimpact on future fertility

European Surgery in Ectopic Pregnancy(ESEP) study

ESEP: Tan Lines from Typical Summer Activities ……

ESEP

BackgroundRCT systemic MTX vs salpingo(s)tomy

1993-1996, the Netherlands 5 centers, n = 100

Primary outcome: elimination of tubal pregnancy (hCG < 2 IU/L) and preservation of the tube by primary treatment

Secondary outcomes:• Spontaneous IUP• Repeat EP• Quality of Life• Patients preference• Costs

Multiple doseMTX im Salpingo(s)tomy

randomisation

MTX - systemic methotrexate (four 1.0 mg/kg doses of intramuscular methotrexate alternated with 0.1 mg/kg oral folinic acid)

Inclusion: laparoscopically

confirmed unruptured

tubal pregnancy

ConclusionsMTX vs salpingo(s)tomy

• Both treatments were equally effective• Fertility after MTX was not improved• MTX had more negative impact on Quality of Life• MTX is only cost-effective in patients with serum

hCG < 3,000 IU/l in a non invasive strategy

Surgery: primary intervention

Reference Hajenius et al Lancet 1997, Nieuwkerk et al Fertil Steril 1998, Mol et al Am J Obstet Gynecol 1999

Surgery for tubal pregnancysalpingo(s)tomy or salpingectomy?

Review 1996• No difference for IUP• Salpingostomy: more repeat EP, more persistent trophoblast

No advantage for salpingostomy

However? ….. did not take into account:• Wish to conceive• Time to IUP• Spontaneous conception vs IVF-ET

Reference: Clausen et al, Acta Obstet Gynecol. Scand 1996

Salpingo(s)tomy or salpingectomy?retrospective cohort study

1988 AZG en AMC• salpingo(s)tomy n = 56• salpingectomy n = 79

Reference: BW Mol et al Hum Reprod 1998

FRR IUP: 1.9 (0.91-3.8)• no tubal pathology 1.4 (0.68-2.7)• bilateral tubal pathology 3.1 (0.76-12)

FRR repeat EP 2.4 (0.57-11)

Persistent trophoblast 7%

ESEP study salpingo(s)tomy vs salpingectomy

in tubal EP with a normal contra lateral tube

Pros:• Shorter time to IUP• More spontaneous IUP

Cons:• Risk repeat EP• Persistent trophoblast

?ESEP!

Salpingo(s)tomy vs salpingectomyimpact on future fertility

European Surgery in Ectopic Pregnancy(ESEP) study

salpingo(s)tomy salpingectomy

randomisation

laparoscopy

Informed consent

All patients suspected for tubal EPsceduled for surgery

Exclusion criteria• shock• pregnant after IVF-ET• known bilateral tubal pathology• history of tubectomy

Tubal EP?Normal

contra lateral tube?

Inclusion and randomisation

Websitehttp://www.esepstudy.nlInlog: ghzWachtwoord: Hart• Download patient

information• Online CRF• Online Randomisation

Salpingo(s)tomy or salpingectomy

Primary outcome • Spontanous IUP (follow-up 3 yrs post surgery)

Secondary outcomes • Repeat EP• Persistent trophoblast• Costs• Patients preference

ESEP coördinators

serum hCG check in both strategies

ESEP 33 centers

The Netherlands 19 centersAMC OLVGUMCG Máxima MCUMCN BovenIJLUMC Twee Steden AZM Reinier de GraafUMCU Antonius Vie curi Lucas AndreasEde DeventerGelre Waterland Bronovo Groene Hart

UK 3 centers

Kings College Hospital, LondenBirmingham (mec) Leeds (mec)

Sweden 8 centersSahlgrenska University SkövdeNälVarbergHalmstadÖrebro KKKarlstadSödersjukhuset KK

Norway 1 centerAkershus, Oslo

USA 1 center Wakeforest, NC

New….. Participating centers

Wake Forest University, Winston-Salem, NC, USA

Tamer Yalcinkaya

Ineke Janssen

Groene Hart ziekenhuisGouda

InclusionTotal 115 SE 45

NL 45UK 25

Demonstratie website

European Surgery in Ectopic Pregnancy(ESEP) study

ESEP

Hartelijk dank namens de studiegroepFemke Mol, Petra Hajenius, Ben Willem Mol, Pim Ankum, Fulco van der Veen

en Nancy Klein Annika Strandell, Emma Sawyer en Davor Jurkovic

esep@amc.uva.nl

New……newsletter

Online randomisation https://lin1.holding.gu.se/esep/

Select center

Password Dessel

Login

1. PIN

2. Initials

3. Date of Birth yyyy-mm-dd

4. History tubal

pathology

5. Submit

Online randomisation

Emergency procedurerandomisation by envelopes

After randomisation, please inform by • Fax: +46 31 419 756• E-mail: esep@amc.uva.nl