Clinical Trial: Early Versus Delayed Cholecystectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy

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 Summary: 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.
Sponsor: Sisli Etfal Training & Research Hospital

Current Primary Outcome: Hospital stay [ Time Frame: 4 to 8 weeks ]

time spent totally in the hospital; time from admission to discharge from hospital in days


Original Primary Outcome: Same as current

Current Secondary Outcome: Costs of treatment [ Time Frame: 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


Original Secondary Outcome: Costs [ Time Frame: 4 to 8 weeks ]

costs spent for surgery and hospital stay in days; costs from admission to discharge from hospital in USD


Information By: Sisli Etfal Training & Research Hospital

Dates:
Date Received: March 28, 2017
Date Started: November 1, 2015
Date Completion:
Last Updated: April 23, 2017
Last Verified: April 2017