Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy.

N/AActive Not RecruitingNCT07642791

University of Zurich300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Ovarian Cancer Cholecystolithiasis

Interventions

Opportunistic salpingectomyPROCEDURE

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

CholecystectomyPROCEDURE

Cholezystectomy as controll group

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: within 6 weeks after surgery

Secondary Outcomes

Operating time

Operating time measured in minutes from incision until skin stich

Time frame: Operating time in minutes during surgical procedure

Length of hospital stay

Length of hospital stay calculated in days

Time frame: Length of hospital stay: The number of days patients remain hospitalized after surgery untill discharge assedd at discharge (assessed at around 5 days).