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

Cholecystitis, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02972944
• Other study ID #: 326/2016
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Kuopio University Hospital
• Contact: Hannu Paajanen, Professor
• Phone: 17 173 311
• Email: Hannu.Paajanen[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic cholecystectomy

• Non-operative treatment

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Pohjois-Savo

Sponsors (10)

Lead Sponsor	Collaborator
Kuopio University Hospital	Central Hospital of Hämeenlinna, Central Hospital of Jorvi, Jyväskylä Central Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Oulu University Hospital, Päijänne Tavastia Central Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life RAND-36 scores	Quality of life according to RAND-36	pre-operatively and 1 year postoperatively
Secondary	Pain scores (0-100)	Pain (VAS, range 0-100)	pre-operatively, 1 week, 1 month and 1 year postoperatively
Secondary	Number of patients with failure of antibiotic therapy	Recurrent cholecystitis after antibiotic therapy	1 week, 1 month and 1 year postoperatively
Secondary	Time of hospitalization (days)	Length of time at hospital	1 month
Secondary	Mortality (number of patients)	Death within 30 d	1 month
Secondary	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
Secondary	Cost analysis in euros	cost analysis comparison between groups	1 week, 1 month and 1 year postoperatively