Laparoscopic Tubal Preservation Surgery

NCT03253588 | Completed

• 1 other identifier: 106002-E
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• peri- and post-operative parameters

  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)

  between January 2009 and November 2016

Secondary Outcomes (1)

• factors affecting the surgical success rate

  between January 2009 and November 2016

Interventions

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).

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Salpingostomy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: February 21, 2017
• Primary Completion: September 15, 2017
• Study Completion: October 15, 2017
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)