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
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
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: [email protected]