Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study

Conditions
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Prophylactic Salpingectomy, Opportunistic Salpingectomy, Laparoscopic Cholecystectomy

Intervention / Treatment
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* Procedure: Salpingectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salpingectomy<br>Opportunistic salpingectomy at the time of laparoscopic cholecystectomy | Procedure: Salpingectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy | Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy | At time of laparoscopic cholecystectomy surgery | 

Secondary Outcome Measures

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