Laparoscopic CholecystectomyNCT07530874
Ultrasonography vs Intraoperative Laparoscopic Cholecystectomy for Gall Stone Disease
An observational study of Laparoscopic Cholecystectomy and Ultrasonography, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Cholecystectomy, Ultrasonography, Difficult Surgery
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2021to 1 Mar 2023
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients presenting to the out patient department of general surgery at the hospital. No preference ot any race, sex or age.
Who may be able to join
- All patients with gallstone disease in USG who underwent laparoscopic cholecystectomy
Who cannot join
- patient refusal
- suspected or histological confirmation of gallbladder carcinoma
- patients with dilated CBD and stones in CBD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
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.
- Being tested
- laparoscopic cholecystectomy
- Keywords
- cholelithiasis, cholecystectomy, intraoperative findings
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
observing the intraoperative findings during laparoscopic cholecystectomy and comparing it with the variable used in patient's USG report.
What is being measured
The primary outcome is the main question the study is designed to answer.
time taken for surgery
time taken for surgery is divided into 3 stages and filled accordingly
Measured: 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)
Measured: up to 7 days
complications
conversion, bleeding and bile leak
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Sep 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Nepal Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bineet Thapa, Nepal Medical College and Teaching Hospital
- Investigators
- Bineet Thapa, MS, Principal investigator, Nepal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530874
- Sponsor's protocol ID
- 35-078/079
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31858450Sutcliffe 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 27591176Hu 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 at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasonography Findings With Intraoperative Findings in Patients Undergoing Laparoscopic Cholecystectomy for Gall Stone Disease
- ClinicalTrials.gov ID
- NCT07530874
- Acronym / sponsor ID
- 35-078/079
- Keywords
- cholelithiasis, cholecystectomy, intraoperative findings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Nepal Medical College and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients presenting to the out patient department of general surgery at the hospital. No preference ot any race, sex or age.
Key inclusion criteria (1 listed)
- All patients with gallstone disease in USG who underwent laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- patient refusal
- suspected or histological confirmation of gallbladder carcinoma
- patients with dilated CBD and stones in CBD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic cholecystectomyobserving the intraoperative findings during laparoscopic cholecystectomy and comparing it with the variable used in patient's USG report. | Procedure or surgery | – |
Primary outcome
time taken for surgery
Time frame: immediately noticed during surgeyr
time taken for surgery is divided into 3 stages and filled accordingly
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)
complications
Time frame: during surgery
conversion, bleeding and bile leak
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 31858450Cao 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.
- Background: PubMed 27591176Sutcliffe 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.
- Background: PubMed 28739121Hu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bineet Thapa, MS principal investigator
Nepal Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Ultrasonography, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time taken for surgery (time frame: immediately noticed during surgeyr). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530874, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.