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

Kuopio University Hospital

Status: Unknown

Conditions: Cholecystitis, Acute

Treatments: Procedure: Non-operative treatment; Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02972944

326/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Cholecystectomy group

Experimental group

Description:

Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.

Treatment:

Procedure: Laparoscopic cholecystectomy

Non-operative group

Active Comparator group

Description:

Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.

Treatment:

Procedure: Non-operative treatment