Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE) (SaLCHE)

April 16, 2018 updated by: Medical University of Graz

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldbach, Austria, 8330
        • Landeskrankenhaus Feldbach
      • Graz, Austria, 8036
        • Medical University of Graz
      • Graz, Austria, 8020
        • Krankenhaus der Barmherzigen Brüder Graz
      • Graz, Austria, 8020
        • Krankenhaus der Elisabethinen Graz
      • Hartberg, Austria, 8230
        • Landeskrankenhaus Hartberg
      • St. Veit/Glan, Austria, 9300
        • Krankenhaus der Barmherzigen Brüder St. Veit/Glan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salpingectomy
Opportunistic salpingectomy at the time of laparoscopic cholecystectomy
Procedure: Salpingectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Krankenhaus der Barmherzigen Bruder Graz
Krankenhaus der Elisabethinen Graz
Landeskrankenhaus Feldbach
LKH Hartberg
Krankenhaus der Barmherzigen Brüder St. Veit/Glan

Investigators

  • Study Chair: Karl F Tamussino, MD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

May 28, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SaLCHE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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