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CompletedNCT07530874Updated Apr 15, 2026

Ultrasonography vs Intraoperative Laparoscopic Cholecystectomy for Gall Stone Disease

An observational study in Laparoscopic Cholecystectomy, Ultrasonography and Difficult Surgery, sponsored by Nepal Medical College and Teaching Hospital. Completed at 1 site in Nepal. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Nepal Medical College and Teaching Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
130
Sex
All
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Study 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. Are there any specific parameters of ultrasonography that immediately concern the operating surgeon?
  2. Should surgeons depend on the ultrasonography reports to counsel the patients differently?
Read the 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.

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Conditions studied

  • Laparoscopic Cholecystectomy
  • Ultrasonography
  • Difficult Surgery

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Keywords

  • cholelithiasis
  • cholecystectomy
  • intraoperative findings
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In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 130 is below the median of 200 across 83 observational studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Nepal Medical College and Teaching Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
130 participants (actual)
Target follow-up
14 Days
Patient registry
Yes

Interventions

  • Procedurelaparoscopic cholecystectomy

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

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What researchers measure

Primary outcomes

  1. time taken for surgery

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

    Time frame: immediately noticed during surgeyr

  2. length of hospital stay

    patient admission being day 0 and counted till patient's discharge day (usually on 2nd day and upto 7 days)

    Time frame: up to 7 days

  3. complications

    conversion, bleeding and bile leak

    Time frame: during surgery

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Study locations

1 site
  • Nepal Medical College
    Kathmandu, Bagmati 977, Nepal
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References and documents

Publications

  • 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. PubMed 31858450 ↗
  • 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. PubMed 27591176 ↗
  • 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. PubMed 28739121 ↗

Study documents

  • Protocol, analysis plan and consent form · Aug 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07530874
Lead sponsor
Nepal Medical College and Teaching Hospital
Responsible party
Bineet Thapa (Principal Investigator, Nepal Medical College and Teaching Hospital) — Principal investigator
First posted
Apr 15, 2026
Start date
Sep 1, 2021
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023
Last update
Apr 15, 2026

Study contacts

Bineet Thapa, MS
principal investigator · Nepal Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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