Study protocol

The ESEP study: Salpingostomy versus salpingectomy for tubal ectopic pregnancy; The impact on future fertility: A randomised controlled trial

Femke Mol¹ , Annika Strandell² , Davor Jurkovic³ , Tamer Yalcinkaya⁴ , Harold R Verhoeve⁵ , Carolien AM Koks⁶ , Paul JQ van der Linden⁷ , Giuseppe CM Graziosi⁸ , Andreas L Thurkow⁹ , Annemieke Hoek¹⁰ , Lars Hogström¹¹ , Ingemar Klinte¹² , Kerstin Nilsson¹³ , Norah M van Mello¹ , Willem M Ankum¹ , Fulco van der Veen¹⁴ , Ben WM Mol^1,6 and Petra J Hajenius¹ for the European Surgery in Ectopic Pregnancy (ESEP) study group

¹Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands

²Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Göteborg, Sweden

³King's Early Pregnancy Unit, King's College Hospital, London, UK

⁴Department of Obstetrics and Gynaecology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA

⁵Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

⁶Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, The Netherlands

⁷Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands

⁸Department of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, The Netherlands

⁹Department of Obstetrics and Gynaecology, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands

¹⁰Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, The Netherlands

¹¹Department of Obstetrics and Gynaecology Kärnssjukhuset Skövde, Sweden

¹²Department of Obstetrics and Gynaecology Norra Älvsborgs Läns Sjukhus (NÄL) Trollhättan, Sweden

¹³Department of Obstetrics and Gynaecology Kvinnokliniken, Universitetssjukhuset Örebro, Sweden

¹⁴Centre for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands

author email corresponding author email

BMC Women's Health 2008, 8:11doi:10.1186/1472-6874-8-11

Published:	26 June 2008

Abstract

Background

For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP.

Methods/Design

International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation.

The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on costs per live birth, including IVF treatment whenever a spontaneous pregnancy does not occur. Patients' preferences will be assessed using a discrete choice experiment.

Discussion

This trial will provide evidence on the trade off between salpingostomy and salpingectomy for tubal EP in view of the pros and cons of both interventions and will offer guidance to clinicians in making the right treatment choice.

Trial registration

Current Controlled Trials ISRCTN37002267