Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial.
Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy.



In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267.



446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60·7% after salpingotomy and 56·2% after salpingectomy (fecundity rate ratio 1·06, 95% CI 0·81-1·38; log-rank p=0·678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15·0, 2·0-113·4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1·6, 0·8-3·3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial.



In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy.



Netherlands Organisation for Health Research and Development (ZonMW), Region Västra Götaland Health & Medical Care Committee.
Centre for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. Electronic address: f.mol@amc.nl.
Femke
F
Mol
Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Norah M
NM
van Mello
Sahlgrenska University Hospital, Göteborg, Sweden.
Annika
A
Strandell
Sahlgrenska University Hospital, Göteborg, Sweden.
Karin
K
Strandell
King's Early Pregnancy Unit, King's College Hospital, London, UK; Department of Obstetrics and Gynaecology, University College London Hospital, London, UK.
Davor
D
Jurkovic
King's Early Pregnancy Unit, King's College Hospital, London, UK.
Jackie
J
Ross
Penn Fertility Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Kurt T
KT
Barnhart
Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Tamer M
TM
Yalcinkaya
Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
Harold R
HR
Verhoeve
Antonius Hospital, Nieuwegein, Netherlands.
Giuseppe C M
GCM
Graziosi
Máxima Medical Centre, Veldhoven, Netherlands.
Carolien A M
CAM
Koks
NU Hospital Group, Trollhättan, Sweden.
Ingmar
I
Klinte
Skaraborg Hospital, Skövde, Sweden.
Lars
L
Hogström
Groene Hart Hospital, Gouda, Netherlands.
Ineke C A H
ICAH
Janssen
Reinier de Graaf Hospital, Delft, Netherlands.
Harry
H
Kragt
University Medical Centre Groningen, University of Groningen, Groningen, Netherlands.
Annemieke
A
Hoek
Leiden University Medical Centre, Leiden, Netherlands.
Trudy C M
TCM
Trimbos-Kemper
Utrecht University Medical Centre, Utrecht, Netherlands.
Frank J M
FJM
Broekmans
Radboud University Medical Centre, Nijmegen, Netherlands.
Wim N P
WNP
Willemsen
Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Willem M
WM
Ankum
Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands; School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
Ben W
BW
Mol
Centre for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Madelon
M
van Wely
Centre for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Fulco
F
van der Veen
Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Petra J
PJ
Hajenius
D000328:Adult; D005060:Europe; D005187:Fallopian Tubes / Q000601:surgery*; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D011247:Pregnancy; D011274:Pregnancy, Tubal / Q000601:surgery*; D058994:Salpingectomy; D016896:Treatment Outcome; D014481:United States