NCT07530874

Brief Summary

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:

  1. 1.Are there any specific parameters of ultrasonography that immediately concern the operating surgeon?
  2. 2.Should surgeons depend on the ultrasonography reports to counsel the patients differently?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

August 15, 2024

Last Update Submit

April 8, 2026

Conditions

Laparoscopic CholecystectomyUltrasonographyDifficult Surgery

Keywords

cholelithiasischolecystectomyintraoperative findings

Outcome Measures

Primary Outcomes (3)

  • time taken for surgery

    time taken for surgery is divided into 3 stages and filled accordingly

    immediately noticed during surgeyr

  • length of hospital stay

    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

    conversion, bleeding and bile leak

    during surgery

Interventions

laparoscopic cholecystectomyPROCEDURE

observing the intraoperative findings during laparoscopic cholecystectomy and comparing it with the variable used in patient's USG report.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients with gallstone disease in USG who underwent laparoscopic cholecystectomy

You may not qualify if:

  • patient refusal
  • suspected or histological confirmation of gallbladder carcinoma
  • patients with dilated CBD and stones in CBD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nepal Medical College

Kathmandu, Bagmati, 977, Nepal

Location

Related Publications (3)

  • 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.

    PMID: 31858450BACKGROUND

  • 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.

    PMID: 27591176BACKGROUND

  • 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.

    PMID: 28739121BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Bineet Thapa, MS

    Nepal Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2024

First Posted

April 15, 2026

Study Start

September 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)