NCT07642791

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable ovarian-cancer

Timeline
36mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026May 2029

Study Start

First participant enrolled

April 15, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

April 17, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications assesed with Comprehensive complication index.

    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.

    within 6 weeks after surgery

Secondary Outcomes (2)

  • Operating time

    Operating time in minutes during surgical procedure

  • 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).

Study Arms (2)

Experimental group

EXPERIMENTAL

Opportunistic salpingectomy during surgery.

Procedure: Opportunistic salpingectomyProcedure: Cholecystectomy

Control group

ACTIVE COMPARATOR

Elective cholecystectomy

Procedure: Cholecystectomy

Interventions

Cholezystectomy as controll group

Control groupExperimental group

Opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy will be performed in study group, while the control group undergo cholecystectomy without salpingectomy.

Experimental group

Eligibility Criteria

Age45 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Details. "sex and gender" dimensions are not relevant in this study including only female gender.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Visceral Surgery and Transplantation , University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCholecystolithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Dilmurodjon MDE Eshmuminov, MD

    Univercity hospital zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

June 11, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations