- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07642791
Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy.
Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- Division of Visceral Surgery and Transplantation , University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Opportunistic salpingectomy during surgery.
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Opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy will be performed in study group, while the control group undergo cholecystectomy without salpingectomy.
Cholezystectomy as controll group
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Active Comparator: Control group
Elective cholecystectomy
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Cholezystectomy as controll group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications assesed with Comprehensive complication index.
Time Frame: within 6 weeks after surgery
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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.
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within 6 weeks after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operating time
Time Frame: Operating time in minutes during surgical procedure
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Operating time measured in minutes from incision until skin stich
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Operating time in minutes during surgical procedure
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Length of hospital stay
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).
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Length of hospital stay calculated in days
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Length of hospital stay: The number of days patients remain hospitalized after surgery untill discharge assedd at discharge (assessed at around 5 days).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilmurodjon MDE Eshmuminov, MD, Univercity hospital zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Digestive System Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Biliary Tract Diseases
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Gallbladder Diseases
- Cholelithiasis
- Ovarian Neoplasms
- Cholecystolithiasis
- Surgical Procedures, Operative
- Digestive System Surgical Procedures
- Biliary Tract Surgical Procedures
- Cholecystectomy
Other Study ID Numbers
- 2026-00157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Opportunistic salpingectomy
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Umeå UniversityKarolinska Institutet; Uppsala University; Göteborg University; Queen Mary University... and other collaboratorsNot yet recruitingMenopause | Opportunistic SalpingectomySweden
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Radboud University Medical CenterCatharina Ziekenhuis EindhovenActive, not recruitingSTOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands (STOPOVCA)Ovarian Cancer | Risk ReductionNetherlands
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CHA UniversityCompletedBenign Uterine DiseaseKorea, Republic of
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompleted
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Technical University of MunichCompletedOsteoporosis | Osteoporotic Fracture of Vertebra | Fracture Risk AssessmentGermany
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Gaziosmanpasa Research and Education HospitalRecruiting
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Jani JacquesRecruiting
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Ege UniversityUnknownEctopic PregnancyTurkey
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University Magna GraeciaUnknownPelvic Pain | Adenomyosis | Uterine Fibroids | Pelvic ProlapseItaly