Laparoscopic Tubal Preservation Surgery

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03253588
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 12.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Procedure: laparoscopic salpingotomy or salpingostomy

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 Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy
• Actual Study Start Date: Feb 21, 2017
• Actual Primary Completion Date: Sep 15, 2017
• Actual Study Completion Date: Oct 15, 2017

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Far Eastern Memorial Hospital	Taipei	New Taipei City	Taiwan	220

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stella Ting Wan Hua, Principal Investigator, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03253588
• Other Study ID Numbers: 106002-E
• First Posted: Aug 18, 2017
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature

Study Results

No Results Posted as of Jul 30, 2019