Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy in a Tertiary Care Centre: A Descriptive Cross-Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366907
• Other study ID #: CMC-IRC/0770798-271
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2023
• Source: Chitwan Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Laparoscopic Cholecystectomy (LC) is the gold standard surgery for symptomatic cholelithiasis with low mortality and morbidity.1,2 However, 1% to 15% of conversion rate to Open Cholecystectomy (OC) during laparoscopic cholecystectomy has been reported.3 Converted cases were associated with increased perioperative time, complication rates, perioperative costs, the length of hospital stay, and a higher 30-day readmission rate.3,4 Conversion was also associated with complications including bile leak, bile duct injury, or bleeding, requiring reoperation or transfusion, and death. A recent detailed critical review found that preoperative variables like male gender, older age, high body mass index, previous abdominal surgery, the severity of cholecystitis, and gallbladder wall thickness were associated with the higher rate of conversion to OC.4 However, data regarding its prevalence lacking in our setting. The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care centre.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

Inclusion Criteria:

• All the cases of Symptomatic Cholelithiasis elected for Laparoscopic Cholecystectomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cholecystectomy
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Laparoscopic Cholecystectomy

Intervention

Other:
• No intervention is done
It is a descriptive cross-sectional study so no groups like case/controls are present. All the cases are included in the study.

Locations

Country	Name	City	State
Nepal	Chitwan Medical College Teaching Hospital	Bharatpur	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Chitwan Medical College

Country where clinical trial is conducted

Nepal, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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