Skip to main content
OpenTrials
Completed

NCT Number: NCT03253588

Laparoscopic Tubal Preservation Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Far Eastern Memorial Hospital

Taipei, New Taipei City, 220, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laparoscopic salpingotomy or salpingostomy

Procedure

A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).

Primary outcomes

  1. peri- and post-operative parameters

    Time frame: 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 outcomes

  1. factors affecting the surgical success rate

    Time frame: between January 2009 and November 2016

    relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis)

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.