Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? (RCT)

Damanhour Teaching Hospital

Status: Completed

Conditions: Acute Cholecystitis

Treatments: Procedure: Early laparoscopic cholecystectomy; Procedure: Late laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03999645

DTH:19002

Details and patient eligibility

About

Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).

Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.

Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.

Enrollment: 120 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with AC within seven days from symptom onset
• American Society of Anesthesiologist (ASA) physical status ≤ II
• Age from 21 to 60 years

Exclusion criteria

• Patients with ASA physical status > II
• Age < 21 years or > 60 years
• Child classification B or C
• Choledocholithiasis
• Acute pancreatitis
• Severe sepsis
• Gallbladder perforation
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Group E: Early LC (n=60)

Active Comparator group

Description:

Early laparoscopic cholecystectomy (within 72h from symptom onset)

Treatment:

Procedure: Early laparoscopic cholecystectomy

Group L: Late LC (n=60)

Active Comparator group

Description:

Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)

Treatment:

Procedure: Late laparoscopic cholecystectomy