Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy.

NCT07642791 — Not applicable, Active not recruiting, 300 participants, University of Zurich

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Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Registry	NCT07642791
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	300 (Actual)
Sponsor	University of Zurich (Other)
Conditions	Ovarian Cancer, Cholecystolithiasis
Interventions	Opportunistic salpingectomy, Cholecystectomy (Procedure)
Dates	start 2026-04-15, primary completion 2028-05-31 (estimated), completion 2029-05-31 (estimated), first posted 2026-06-11, last updated 2026-06-11
Locations	1 site in Switzerland

-Summary

The knowledge, coupled with epidemiological studies demonstrating lower ovarian cancer rates in women with a history of tubal sterilization has led to recommendations for opportunistic salpingectomy at the time of benign gynecological surgery. However, this recommendation was not explored in the setting of non-gynecological surgeries, of most if the surgery performed not in pelvis.

This study aims to evaluate the safety of performing opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy in women aged 45 years or older. Of note, the only available prospective study from Austria evaluated feasibility of combined operation. By assessing complication rates and other perioperative outcomes, the study seeks to determine if this combined approach is a safe for opportunistic ovarian cancer prevention. Ultimately, this research may inform surgical practice and potentially reduce the incidence of ovarian cancer in this population.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental group	Experimental	Procedure: Opportunistic salpingectomy; Procedure: Cholecystectomy	Opportunistic salpingectomy during surgery.
Control group	Active comparator	Procedure: Cholecystectomy	Elective cholecystectomy

Opportunistic salpingectomy (Procedure): Opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy will be performed in study group, while the control group undergo cholecystectomy without salpingectomy.
Cholecystectomy (Procedure): Cholezystectomy as controll group

+Outcome measures

Primary outcomes

Postoperative complications assesed with Comprehensive complication index. [within 6 weeks after surgery]: This will be the primary outcome measure, encompassing any complications assessed with Comprehensive Complication Index. The range between 0 and 100. The higher score means more complications.

Secondary outcomes

Operating time [Operating time in minutes during surgical procedure]: Operating time measured in minutes from incision until skin stich
Length of hospital stay [Length of hospital stay: The number of days patients remain hospitalized after surgery untill discharge assedd at discharge (assessed at around 5 days).]: Length of hospital stay calculated in days

+Eligibility

Sex: Female, ages: 45 Years to any

Inclusion Criteria:

* Women aged 45 years or older.
* No known history of ovarian or fallopian tube cancer.
* Completed family planning.
* Scheduled to undergo elective laparoscopic cholecystectomy for benign gallbladder disease.
* Able to provide informed consent.
* Willing to comply with study procedures and follow-up assessments.

Exclusion Criteria:

* Previous abdominal Surgery or any inflammatory bowel disease.
* Current pregnancy or breastfeeding (verbally asked).
* Contraindications to laparoscopic surgery (e.g., severe cardiopulmonary disease, extensive prior abdominal surgery).
* Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or interfere with follow-up.
* Participation in another clinical trial that may confound the results of this study.

+Locations (1)

Facility	City	Country	Status
Division of Visceral Surgery and Transplantation , University Hospital Zurich	Zurich	Switzerland

+Investigators

Dilmurodjon MDE Eshmuminov, MD, Principal investigator, Univercity hospital zurich