ESEP

European Surgery Ectopic Pregnancy

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Randomised controlled trial of salpingo(s)tomy versus salpingectomy for tubal pregnancy; the impact on future fertility

Background
The incidence of tubal pregnancy is approximately 1-2 % of all pregnancies. An early diagnosis ispossible by transvaginal sonography in combination with serum human chorionic gonadotrophin (hCG)measurements. The effectiveness of medical treatment with methotrexate has been compared with laparoscopic surgery in several randomized clinical trials. Interpretation of these data indicate that the area of use of methotrexate in the treatment of ectopic pregnancy is limited to a small proportion of all patients with tubal pregnancy leaving surgical management to be the most important treatment.Whether surgical treatment should be performed conservatively or radically in patients who want topreserve their reproductive capacity is subject to debate.

Objective
The conservative approach, salpingo(s)tomy, preserves the tube, but bears the risk of persistent trophoblast and of repeat tubal pregnancy. The radical approach, salpingectomy, bears no risk of persistent trophoblast and limits the risk of repeat tubal pregnancy, but leaves only one tube for reproductive capacity. Our objective is whether the potential advantage of salpingo(s)tomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages of this treatment, i.e. persistent trophoblast and an increased risk for ectopic pregnancy.

Study-design
International multi centre randomised controlled trial in a Dutch-Swedish-British collaboration.

Population
All hemodynamically stable patients with a presumptive diagnosis of tubal pregnancy, who are scheduled for surgical treatment, will be eligible for the trial. Excluded are patients pregnant after IVFETor ICSI and/or with known tubal pathology. At surgery, that can either be performed laparoscopically or by laparotomy, the presence of a tubal pregnancy must be confirmed. Only patients with a tubal pregnancy that allows both interventions, and a contralateral tube that would allow spontaneous conception in case of salpingectomy, are being included. Randomisation will be performed during surgery with an internet randomisation program.

Intervention and follow-up
Salpingo(s)tomy and salpingectomy are performed following standard procedures used in the residential hospitals. For a period of 36 months, every six months, starting from the date of the operation, the patient will be contacted to assess her fertility status by means of a questionnaire.

Outcome measures and analysis
The primary outcome measure is the occurrence of spontaneous vital intra uterine pregnancy. Secondary outcome measures are persistent trophoblast and repeat ectopic pregnancy.
The analysis will be performed according to the intention to treat principle. Short term outcome measuresare expressed in relative risks and their 95% confidence intervals. Future fertility is assessed by means of life table analysis. Kaplan-Meier curves are constructed, estimating the cumulative probability of spontaneous intra-uterine pregnancy and repeat tubal pregnancy over time. The differences between both treatment modalities are expressed as a Fecundity Rate Ratio with 95% confidence interval, calculated through Cox proportional hazard analysis. A cost-effectiveness analysis will be performed, using data on costs and used resources in a subset of the participating centers.

Trial registration

Current Controlled Trials ISRCTN37002267
Nederlands trial register: NTR115

Funding
This trial is supported by a grant of The Netherlands Organization for Health Research and Development (Agiko stipendium grant 920-03-328, Clinical fellow grant 40-00703-97-05-154).

Protocol
Study protocol in BMC Women's Health