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OpenTrials
Completed

NCT Number: NCT05366907

Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Cholecystectomy Digestive System Diseases Laparoscopic Cholecystectomy

Age range

10 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chitwan Medical College Teaching Hospital

Bharatpur, Bagmati, 44207, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Laparoscopic to Open cholecystectomy

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Chitwan Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 9, 2022
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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