Clinical Trial: Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Multi-center Study of Acute Cholecystitis in the Elderly: Comparison of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics

Brief Summary: Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed.

Detailed Summary:

The increasing age is one of the main risk factors for developing complicated gallstone disease. Currently, there is lack of good quality studies comparing risks and benefits of early laparoscopic cholecystectomy in the elderly patients. Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.

Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy vs. conservative) with the least morbidity for elderly patients with acute cholecystitis.

Study design: multicenter randomized controlled trial (RCT).

Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly allocated to either early laparoscopic cholecystectomy or treatment with antibiotics. Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the patients with ASA-class above 4.

Interventions: The study group of patients will undergo early laparoscopic cholecystectomy within 48 hours after hospitalization. The other group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later.

Primary outcome: Assessment of morbidities and individual quality of life. Secondary outcomes include number of hospital admissions, length of hospitalization, pain, complications, mortality and cost analysis.

Sample size and data-analysis: Based on data of previous studies the recruitment of 200 patients in total is expected. Follow-up will be for 12 months.


Sponsor: Kuopio University Hospital

Current Primary Outcome: Specific Morbidity Index Scores [ Time Frame: 1 year postoperatively ]

The primary outcome is morbidity, all complications will be scored (according to "morbidity-index" -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life RAND-36 scores [ Time Frame: pre-operatively and 1 year postoperatively ]
    Quality of life according to RAND-36
  • Pain scores (0-100) [ Time Frame: pre-operatively, 1 week, 1 month and 1 year postoperatively ]
    Pain (VAS, range 0-100)
  • Number of patients with failure of antibiotic therapy [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    Recurrent cholecystitis after antibiotic therapy
  • Time of hospitalization (days) [ Time Frame: 1 month ]
    Length of time at hospital
  • Mortality (number of patients) [ Time Frame: 1 month ]
    Death within 30 d
  • Number of patients with complications [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
  • Cost analysis in euros [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    cost analysis comparison between groups


Original Secondary Outcome:

  • Quality of life RAND-36 scores [ Time Frame: pre-operatively and 1 year postoperatively ]
    Quality of life according to RAND-36
  • Pain scores (0-100) [ Time Frame: pre-operatively, 1 week, 1 month and 1 year postoperatively ]
    Pain (VAS, range 0-100)
  • Number of patients with failure of antibiotic therapy [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    Recurrent cholecystitis after antibiotic therapy
  • Time of hospitalization (days) [ Time Frame: 1 month ]
    Lenght of time at hospital
  • Mortality (number of patients) [ Time Frame: 1 month ]
    Death within 30 d
  • Number of patients with complications [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
  • Cost analysis in euros [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    cost analysis comparison between groups


Information By: Kuopio University Hospital

Dates:
Date Received: November 8, 2016
Date Started: October 2016
Date Completion: December 2020
Last Updated: November 28, 2016
Last Verified: November 2016