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Salpingo(s)tomy vs salpingectomyimpact on future fertility
European Surgery in Ectopic Pregnancy(ESEP) study
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ESEP: Tan Lines from Typical Summer Activities ……
ESEP
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BackgroundRCT systemic MTX vs salpingo(s)tomy
1993-1996, the Netherlands
5 centers, n = 100Primary 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
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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
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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
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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%
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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!
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Salpingo(s)tomy vs salpingectomyimpact on future fertility
European Surgery in Ectopic Pregnancy(ESEP) study
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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?
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Inclusion and randomisation
Website
http://www.esepstudy.nl
Inlog: ghz
Wachtwoord: Hart• Download patient
information• Online CRF• Online Randomisation
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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
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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
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New….. Participating centers
Wake Forest University, Winston-Salem, NC, USA
Tamer Yalcinkaya
Ineke Janssen
Groene Hart ziekenhuisGouda
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InclusionTotal 115 SE 45
NL 45UK 25
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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
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New……newsletter
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Online randomisation https://lin1.holding.gu.se/esep/
Select center
Password Dessel
Login
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1. PIN
2. Initials
3. Date of Birth
yyyy-mm-dd
4. History tubal
pathology
5. Submit
Online randomisation
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Emergency procedurerandomisation by envelopes
After randomisation, please inform by • Fax: +46 31 419 756• E-mail: [email protected]