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
Highlights
For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice
There are no randomised controlled trials, which have examined the potential benefits of performing salpingostomy in women with no evidence of contra lateral tubal damage as compared to salpingectomy
Despite this lack of evidence, clinicians prefer a salpingectomy over a salpingostomy in the presence of a healthy contra lateral tube [16]
Summary
In the treatment of tubal ectopic pregnancy (EP), laparoscopic surgery remains the cornerstone of treatment [1]. History of tubal pathology this benefit was less clear and in these women there was an increased risk for repeat EP [8] In view of these data, we feel that the most effective type of surgery for women with a tubal EP in the presence of contra lateral tubal pathology with desire for future pregnancy is salpingostomy. Pooled data showed no beneficial effect of salpingostomy on intra uterine pregnancy (IUP) whereas there is an increased risk of repeat EP [3,4] Based on these findings, the Royal College of Obstetricians and Gynaecologists guideline advises salpingectomy as the preferred standard surgical approach for tubal EP [5].
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