1. 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

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

3. Background RCT systemic MTX vs salpingo(s)tomy
, 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)

4. 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

5. 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

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 ( )
no tubal pathology 1.4 ( )
bilateral tubal pathology 3.1 ( )
FRR repeat EP 2.4 ( )
Persistent trophoblast 7%
Reference: BW Mol et al Hum Reprod 1998

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!

8. 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

9. 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

10. Inclusion and randomisation
Website
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. 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

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

14. Inclusion
Total SE NL 45 UK 25

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

18. 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

19. New……newsletter

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

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

22. Emergency procedure randomisation by envelopes
After randomisation, please inform by
Fax: