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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 ……. ESEP. 1993-1996, the Netherlands 5 centers, n = 100. Primary outcome:

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Salpingo(s)tomy vs salpingectomy impact on future fertility

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  1. European Surgery in Ectopic Pregnancy(ESEP) study Salpingo(s)tomy vs salpingectomyimpact on future fertility

  2. ESEP: Tan Lines from Typical Summer Activities …… ESEP

  3. 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 BackgroundRCT systemic MTX vs salpingo(s)tomy 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)

  4. 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 < 3,000IU/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

  5. 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

  6. 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

  7. Pros: Shorter time to IUP More spontaneous IUP Cons: Risk repeat EP Persistent trophoblast ESEP study salpingo(s)tomy vs salpingectomy in tubal EP with a normal contra lateral tube ? ESEP!

  8. European Surgery in Ectopic Pregnancy(ESEP) study Salpingo(s)tomy vs salpingectomyimpact on future fertility

  9. All patients suspected for tubal EP 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 salpingectomy salpingo(s)tomy

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

  11. 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

  12. ESEP33 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 Sweden8 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

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

  14. Total 115SE 45NL 45UK 25 Inclusion

  15. European Surgery in Ectopic Pregnancy(ESEP) study Demonstratie website

  16. 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

  17. New……newsletter

  18. Online randomisation https://lin1.holding.gu.se/esep/ Password Dessel Select center Login

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

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

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