Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

Not Applicable

Completed

• Conditions: Laparoscopic Cholecystectomy; Opportunistic Salpingectomy; Prophylactic Salpingectomy
• Interventions: Procedure: Salpingectomy

• Registration Number: NCT03171467
• Lead Sponsor: Medical University of Graz

Brief Summary

Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).

Detailed Description

Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.

This study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-28
• Study First Posted: 2017-05-31
• Status Verified: 2018-04
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

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

Inclusion Criteria

• Scheduled (elective) laparoscopic cholecystectomy for a benign indication
• Age >45 years
• Consent

Exclusion Criteria

• Age <45 years
• Desire to preserve fertility
• Cholecystectomy for malignant disease
• Extensive previous abdominal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salpingectomy	Salpingectomy	Opportunistic salpingectomy at the time of laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy	At time of laparoscopic cholecystectomy surgery	Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy

Secondary Outcome Measures

Name	Time	Method
Time	At the time of surgery	Time (in minutes) from completion of cholecystectomy to completion of bilateral salpingectomy
Port repositioning	At surgery	Rate of port repositioning
Complications	30 days	Number of complications due to salpingectomy
Patient-recorded outcome	Preop. and 1 year	Bliem Questionnaire

Trial Locations

Locations (6)

Krankenhaus der Barmherzigen Brüder Graz; 🇦🇹 Graz, Austria

Medical University of Graz; 🇦🇹 Graz, Austria

Landeskrankenhaus Feldbach; 🇦🇹 Feldbach, Austria

Krankenhaus der Elisabethinen Graz; 🇦🇹 Graz, Austria

Landeskrankenhaus Hartberg; 🇦🇹 Hartberg, Austria

Krankenhaus der Barmherzigen Brüder St. Veit/Glan; 🇦🇹 St. Veit/Glan, Austria