- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530874
Ultrasonography vs Intraoperative Laparoscopic Cholecystectomy for Gall Stone Disease
April 8, 2026 updated by: Bineet Thapa, Nepal Medical College and Teaching Hospital
Comparison of Ultrasonography Findings With Intraoperative Findings in Patients Undergoing Laparoscopic Cholecystectomy for Gall Stone Disease
This research is designed to correlate between intraoperative status of gallstone disease patients with their USG findings.
The key question it aims to answer is:
Does the ultrasonography predict laparoscopic cholecystectomy will be difficult?Further analysis will aim to reveal:
- Are there any specific parameters of ultrasonography that immediately concern the operating surgeon?
- Should surgeons depend on the ultrasonography reports to counsel the patients differently?
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Laparoscopic Cholecystectomy is the most common minimally invasive procedure and cholelithiasis is the major indication.
It is associated with early recovery and better outcome yet not all patients have smooth recovery.
USG is commonly used to diagnose gallstone disease.
Not all cholecystectomies are straight forward and some will always face problems.
So it is an added benefit if certain factors can predict such unexpected events and make surgeons alert for the same.
From this study the investigators attempt to identify such factors in USG by comparing it with intraoperative findings and draw conclusions.
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bagmati
-
Kathmandu, Bagmati, Nepal, 977
- Nepal Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
all patients presenting to the out patient department of general surgery at the hospital.
No preference ot any race, sex or age.
Description
Inclusion Criteria:
- All patients with gallstone disease in USG who underwent laparoscopic cholecystectomy
Exclusion Criteria:
- patient refusal
- suspected or histological confirmation of gallbladder carcinoma
- patients with dilated CBD and stones in CBD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time taken for surgery
Time Frame: immediately noticed during surgeyr
|
time taken for surgery is divided into 3 stages and filled accordingly
|
immediately noticed during surgeyr
|
|
length of hospital stay
Time Frame: up to 7 days
|
patient admission being day 0 and counted till patient's discharge day (usually on 2nd day and upto 7 days)
|
up to 7 days
|
|
complications
Time Frame: during surgery
|
conversion, bleeding and bile leak
|
during surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bineet Thapa, MS, Nepal Medical College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hu ASY, Menon R, Gunnarsson R, de Costa A. Risk factors for conversion of laparoscopic cholecystectomy to open surgery - A systematic literature review of 30 studies. Am J Surg. 2017 Nov;214(5):920-930. doi: 10.1016/j.amjsurg.2017.07.029. Epub 2017 Jul 21.
- Cao Z, Wei J, Zhang N, Liu W, Hong T, He X, Qu Q. Risk factors of systematic biliary complications in patients with gallbladder stones. Ir J Med Sci. 2020 Aug;189(3):943-947. doi: 10.1007/s11845-019-02161-x. Epub 2019 Dec 19.
- Sutcliffe RP, Hollyman M, Hodson J, Bonney G, Vohra RS, Griffiths EA; CholeS study group, West Midlands Research Collaborative. Preoperative risk factors for conversion from laparoscopic to open cholecystectomy: a validated risk score derived from a prospective U.K. database of 8820 patients. HPB (Oxford). 2016 Nov;18(11):922-928. doi: 10.1016/j.hpb.2016.07.015. Epub 2016 Aug 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
August 15, 2024
First Submitted That Met QC Criteria
April 8, 2026
First Posted (Actual)
April 15, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35-078/079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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