Skip to main content
OpenTrials
Completed

NCT Number: NCT03171467

Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prophylactic Salpingectomy Laparoscopic Cholecystectomy Opportunistic Salpingectomy

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Landeskrankenhaus Feldbach, Feldbach, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salpingectomy

Procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. Time

    Time frame: At the time of surgery

    Time (in minutes) from completion of cholecystectomy to completion of bilateral salpingectomy

  2. Port repositioning

    Time frame: At surgery

    Rate of port repositioning

  3. Complications

    Time frame: 30 days

    Number of complications due to salpingectomy

  4. Patient-recorded outcome

    Time frame: Preop. and 1 year

    Bliem Questionnaire

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SaLCHE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 31, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.