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

Abstract

BackgroundFor 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/DesignInternational 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.DiscussionThis 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 registrationCurrent Controlled Trials ISRCTN37002267

Ovarian response to gonadotropins after laparoscopic salpingectomy for ectopic pregnancy

“…Surgery is the common treatment of choice for EP. Clinicians often prefer salpingectomy over salpingostomy because of both the low risk of needing further treatment for persistent trophoblast and the possibility of a repeat EP after a more radical procedure [3]. In addition, studies have shown that the presence of hydrosalpinx may have a deleterious effect on the chances of successful pregnancy after IVF treatment [4], and that prophylactic salpingectomy may enhance the success of IVF [5][6][7].…”

Severe maternal morbidity in ectopic pregnancy is not associated with maternal factors but may be associated with quality of care

“…Control subjects were collected from women who had been operated for tubal EP in The Netherlands as part of the ESEP (European Surgery in Ectopic Pregnancy) study (ISRCTN37002267), an ongoing international multicenter randomized controlled trial that started in October 2005, comparing salpingotomy and salpingectomy in hemodynamic stable women with a tubal EP and a healthy contralateral tube (14). Approval for that study was obtained from the Medical Ethics Committee of the Academic Medical Center (MEC 03/262).…”

Diagnosis and treatment of ectopic pregnancy

“…Wycięcie jajowodu (salpingektomia) jest możliwe w przypadku zakończenia okresu rozrodczego, ponownej ciąży pozamacicznej w tym samym jajowodzie, niedającego się opanować krwawienia oraz rozległego uszkodzenia jajowodu. Porównanie wskaźników ciąż wewnątrzma-cicznych po operacjach nacięcia i wycięcia jajowodów w zdecydowanej większości badań wykazało, że są one wyższe dla leczenia oszczędzającego [22][23][24]. W przypadku nieprawidłowego lub braku drugiego jajowodu u kobiet w wieku reprodukcyjnym istnieje konieczność pozostawienia drugiego jajowodu.…”