Early Versus Delayed Cholecystectomy

Not Applicable

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: laparoscopic cholecystectomy

• Registration Number: NCT03122054
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.

Detailed Description

There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience. This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic. Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy. All operations and medical treatments were done by surgeons having work experience \<2 years.

Study Timeline

• Study Start: 2015-11-01
• Primary Completion: 2016-11-01
• Study Completion: 2017-02-15
• Study First Submitted: 2017-03-28
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Last Update Submitted: 2017-04-23
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• patients suffering acute cholecystitis in their first 72 hours of pain

Exclusion Criteria

• clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L (n:88)	laparoscopic cholecystectomy	patients treated surgically with laparoscopic cholecystectomy immediately
Group D (n:88)	laparoscopic cholecystectomy	patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Hospital stay	4 to 8 weeks	time spent totally in the hospital; time from admission to discharge from hospital in days

Secondary Outcome Measures

Name	Time	Method
Costs of treatment	4 to 8 weeks	costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD