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

NCT ID: NCT03999645

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-04-30

Brief Summary

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.

Conditions

Acute Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group E: Early LC (n=60)

Early laparoscopic cholecystectomy (within 72h from symptom onset)

Group Type: ACTIVE_COMPARATOR

Early laparoscopic cholecystectomy

Intervention Type: PROCEDURE

within 72h from symptom onset

Group L: Late LC (n=60)

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

Group Type: ACTIVE_COMPARATOR

Late laparoscopic cholecystectomy

Intervention Type: PROCEDURE

after 72h up to seven days from symptom onset

Interventions

Early laparoscopic cholecystectomy

within 72h from symptom onset

Intervention Type: PROCEDURE

Late laparoscopic cholecystectomy

after 72h up to seven days from symptom onset

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed M Abdalgaleil, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Osama S Elbalky, MD

Role: STUDY_DIRECTOR

Damanhour Teaching Hospital

Mamdouh M Ibrahim, MD

Role: STUDY_CHAIR

Damanhour Teaching Hospital

Mohamed S Elnagar, MD

Role: STUDY_CHAIR

Damanhour Teaching Hospital

Locations

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Countries

Egypt

Other Identifiers

DTH:19002

Identifier Type: -

Identifier Source: org_study_id