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

Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone

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 with additional cohort of all elderly patients with acute cholecystitis in the study hospitals during study period.

Study Overview

• Status: Unknown
• Conditions: Cholecystitis, Acute
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy; Procedure: Non-operative treatment

Detailed Description

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. 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) and additional cohort of all elderly patients (>75 years old) with acute cholecystitis.

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 control group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later.

Primary outcome: Assessment of morbidities related to acute cholecystitis 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.

In addition of RCT, we decided to record and analyze all acute cholecystitis of elderly patients in study hospitals during the study period. We will present these results in the connection of RCT analysis.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannu Paajanen, Professor; Phone Number: +358 17 173 311; Email: Hannu.Paajanen@kuh.fi
• Study Contact Backup: Name: Antti Kivivuori, MD; Phone Number: +358 443516698; Email: Antti.Kivivuori@esshp.fi

Study Locations

• Finland
  • Pohjois-Savo
    • Kuopio, Pohjois-Savo, Finland, 70200
      • Recruiting
      • Kuopio University Hospital
      • Contact: Tuomo Rantanen, Professor; Phone Number: +358 17 173 311; Email: Tuomo.Rantanen@kuh.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Radiologically confirmed acute cholecystitis
• Age over 75 yrs
• American Association of Anesthesiologists Classification class 2-3
• Duration of symptoms < 5 days

Exclusion Criteria:

• American Association of Anesthesiologists Classification class 4-5
• Age under 75 yrs
• Peritonitis
• Sepsis or septic shock
• Duration of symptoms over 6 days
• Cholestasis or diagnosed stone at common biliary duct.
• Acute Pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cholecystectomy group; Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.	Procedure: Laparoscopic cholecystectomy
Active Comparator: Non-operative group; Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.	Procedure: Non-operative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific Morbidity Index Scores	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)	1 year postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Turku University Hospital; Oulu University Hospital; Tampere University Hospital; Päijänne Tavastia Central Hospital; Jyväskylä Central Hospital; North Karelia Central Hospital; Mikkeli Central Hospital; Central Hospital of Hämeenlinna; Central Hospital of Jorvi

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 326/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO