Early Versus Delayed Cholecystectomy

Sisli Hamidiye Etfal Training and Research Hospital

Status: Completed

Conditions: Acute Cholecystitis

Treatments: Procedure: laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03122054

SHEEAH 12.04.2016/1141

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients suffering acute cholecystitis in their first 72 hours of pain

Exclusion criteria

• clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Group L (n:88)

Other group

Description:

patients treated surgically with laparoscopic cholecystectomy immediately

Treatment:

Procedure: laparoscopic cholecystectomy

Group D (n:88)

Other group

Description:

patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy

Treatment:

Procedure: laparoscopic cholecystectomy