Salpingo(s)tomy vs salpingectomy impact on future fertility

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Presentation transcript:

Salpingo(s)tomy vs salpingectomy impact on future fertility European Surgery in Ectopic Pregnancy (ESEP) study Salpingo(s)tomy vs salpingectomy impact on future fertility

ESEP: Tan Lines from Typical Summer Activities ……

Background RCT 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 Inclusion: laparoscopically confirmed unruptured tubal pregnancy randomisation Multiple dose MTX im Salpingo(s)tomy MTX - systemic methotrexate (four 1.0 mg/kg doses of intramuscular methotrexate alternated with 0.1 mg/kg oral folinic acid)

Conclusions MTX 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 pregnancy salpingo(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 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% Reference: BW Mol et al Hum Reprod 1998

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 salpingectomy impact on future fertility European Surgery in Ectopic Pregnancy (ESEP) study Salpingo(s)tomy vs salpingectomy impact on future fertility

All patients suspected for tubal EP Normal contra lateral tube? sceduled for surgery Exclusion criteria shock pregnant after IVF-ET known bilateral tubal pathology history of tubectomy Informed consent laparoscopy Tubal EP? Normal contra lateral tube? randomisation salpingo(s)tomy salpingectomy

Inclusion and randomisation Website http://www.esepstudy.nl Inlog: ghz Wachtwoord: Hart Download patient information Online CRF Online Randomisation

Salpingo(s)tomy or salpingectomy ESEP coördinators serum hCG check in both strategies Primary outcome Spontanous IUP (follow-up 3 yrs post surgery) Secondary outcomes Repeat EP Persistent trophoblast Costs Patients preference

ESEP 33 centers The Netherlands 19 centers AMC OLVG UMCG Máxima MC UMCN BovenIJ LUMC Twee Steden AZM Reinier de Graaf UMCU Antonius Vie curi Lucas Andreas Ede Deventer Gelre Waterland Bronovo Groene Hart Sweden 8 centers Sahlgrenska University Skövde Näl Varberg Halmstad Örebro KK Karlstad Södersjukhuset KK Norway 1 center Akershus, Oslo UK 3 centers Kings College Hospital, Londen Birmingham (mec) Leeds (mec) USA 1 center Wakeforest, NC

New….. Participating centers Groene Hart ziekenhuis Gouda Ineke Janssen Wake Forest University, Winston-Salem, NC, USA Tamer Yalcinkaya

Inclusion Total 115 SE 45 NL 45 UK 25

European Surgery in Ectopic Pregnancy (ESEP) study Demonstratie website

ESEP Hartelijk dank namens de studiegroep Femke 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/ Password Dessel Select center Login

Online randomisation 3. Date of Birth yyyy-mm-dd 1. PIN 4. History tubal pathology 2. Initials 5. Submit

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