Laparoscopic Tubal Preservation Surgery

Completed

• Conditions: Ectopic Pregnancy

• Registration Number: NCT03253588
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.

Detailed Description

All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009 and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or laparoscopic salpingotomy were extracted from the database, patient characteristics and surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and subsequent management, subsequent pregnancy) were reviewed from their medical records. Univariate and multivariate logistic regression analysis were employed to predict the presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Primary Completion: 2017-09-15
• Study Completion: 2017-10-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016

Exclusion Criteria

• women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
peri- and post-operative parameters	between January 2009 and November 2016	success rate of tubal preservation surgery (defined by postoperative serum bcg \<5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention)

Secondary Outcome Measures

Name	Time	Method
factors affecting the surgical success rate	between January 2009 and November 2016	relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis)

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Taipei, New Taipei City, Taiwan