Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

NCT05366907 | Completed DMC

• 1 other identifier: CMC-IRC/0770798-271
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 1

Brief Summary

In the current era, laparoscopic cholecystectomy is the treatment of choice for symptomatic gallstone disease. The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care center.

Conditions

Cholelithiasis; Laparoscopic Cholecystectomy; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Laparoscopic to Open cholecystectomy

  Demographic details, previous attack of biliary pathology, underlying condition, Huang classification of the biliary system are collected. And conversion rate among these patients were calculated with CR= number of converted surgeries/(number of converted surgeries + number of LC surgeries) × 100) Objectives- To identify the prevalence of conversion rate and, To compare the CR among independent variables- Age, Sex, history of previous attack with dependent variable Open cholecystectomy.

  1 year

Interventions

No intervention is done OTHER

It is a descriptive cross-sectional study so no groups like case/controls are present. All the cases are included in the study.

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the cases of elective LC admitted at the Department of Surgery at CMCTH were included.

You may qualify if:

• All the cases of Symptomatic Cholelithiasis elected for Laparoscopic Cholecystectomy

You may not qualify if:

• Age \<10 years,
• Gall Bladder Malignancy,
• Adults with preoperative choledocholithiasis, and
• Perforated gall bladder

Sponsors & Collaborators

• Chitwan Medical College: lead

Study Sites (1)

Chitwan Medical College Teaching Hospital

Bharatpur, Bagmati, 44207, Nepal

Location

Related Publications (9)

• Genc V, Sulaimanov M, Cipe G, Basceken SI, Erverdi N, Gurel M, Aras N, Hazinedaroglu SM. What necessitates the conversion to open cholecystectomy? A retrospective analysis of 5164 consecutive laparoscopic operations. Clinics (Sao Paulo). 2011;66(3):417-20. doi: 10.1590/s1807-59322011000300009.

  PMID: 21552665 BACKGROUND

• Aziret M, Karaman K, Ercan M, Vargol E, Toka B, Arslan Y, Oter V, Bostanci EB, Parlak E. Early laparoscopic cholecystectomy is associated with less risk of complications after the removal of common bile duct stones by endoscopic retrograde cholangiopancreatography. Turk J Gastroenterol. 2019 Apr;30(4):336-344. doi: 10.5152/tjg.2018.18272.

  PMID: 30945646 BACKGROUND

• European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146-181. doi: 10.1016/j.jhep.2016.03.005. Epub 2016 Apr 13. No abstract available.

  PMID: 27085810 BACKGROUND

• Deka P, Islam M, Jindal D, Kumar N, Arora A, Negi SS. Analysis of biliary anatomy according to different classification systems. Indian J Gastroenterol. 2014 Jan;33(1):23-30. doi: 10.1007/s12664-013-0371-9. Epub 2013 Sep 5.

  PMID: 24006122 BACKGROUND

• Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81.

  PMID: 7979854 BACKGROUND

• Coffin SJ, Wrenn SM, Callas PW, Abu-Jaish W. Three decades later: investigating the rate of and risks for conversion from laparoscopic to open cholecystectomy. Surg Endosc. 2018 Feb;32(2):923-929. doi: 10.1007/s00464-017-5767-7. Epub 2017 Aug 4.

  PMID: 28779254 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.

  PMID: 28739121 BACKGROUND

• Philip Rothman J, Burcharth J, Pommergaard HC, Viereck S, Rosenberg J. Preoperative Risk Factors for Conversion of Laparoscopic Cholecystectomy to Open Surgery - A Systematic Review and Meta-Analysis of Observational Studies. Dig Surg. 2016;33(5):414-23. doi: 10.1159/000445505. Epub 2016 May 5.

  PMID: 27160289 BACKGROUND

• van de Graaf FW, Zaimi I, Stassen LPS, Lange JF. Safe laparoscopic cholecystectomy: A systematic review of bile duct injury prevention. Int J Surg. 2018 Dec;60:164-172. doi: 10.1016/j.ijsu.2018.11.006. Epub 2018 Nov 12.

  PMID: 30439536 BACKGROUND

Related Links

• DOI

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Harish Chandra Neupane, MS

  CMCTH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 9, 2022
• Study Start: June 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

NE (1)