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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:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic cholecystectomy | Procedure | observing the intraoperative findings during laparoscopic cholecystectomy and comparing it with the variable used in patient's USG report. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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all patients presenting to the out patient department of general surgery at the hospital. No preference ot any race, sex or age.
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| Name | Affiliation | Role |
|---|---|---|
| Bineet Thapa, MS | Nepal Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepal Medical College | Kathmandu | Bagmati | 977 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31858450 | Background | 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. | |
| 27591176 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 16, 2021 | Aug 15, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 28739121 | Background | 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. |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |