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Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03171467
Acronym
SaLCHE
Enrollment
100
Registered
2017-05-31
Start date
2016-08-01
Completion date
2018-04-01
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy, Opportunistic Salpingectomy, Prophylactic Salpingectomy

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.

Interventions

PROCEDURESalpingectomy

Sponsors

Krankenhaus der Barmherzigen Brüder Graz
CollaboratorUNKNOWN
Krankenhaus der Elisabethinen Graz
CollaboratorUNKNOWN
Landeskrankenhaus Feldbach
CollaboratorOTHER
LKH Hartberg
CollaboratorUNKNOWN
Krankenhaus der Barmherzigen Brüder St. Veit/Glan
CollaboratorUNKNOWN
Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomyAt time of laparoscopic cholecystectomy surgeryEvaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy

Secondary

MeasureTime frameDescription
Patient-recorded outcomePreop. and 1 yearBliem Questionnaire
Port repositioningAt surgeryRate of port repositioning
Complications30 daysNumber of complications due to salpingectomy
TimeAt the time of surgeryTime (in minutes) from completion of cholecystectomy to completion of bilateral salpingectomy

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026