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

Not Applicable

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: Early laparoscopic cholecystectomy; Procedure: Late laparoscopic cholecystectomy

• Registration Number: NCT03999645
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-23
• Study First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Study First Posted: 2019-06-27
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E: Early LC (n=60)	Early laparoscopic cholecystectomy	Early laparoscopic cholecystectomy (within 72h from symptom onset)
Group L: Late LC (n=60)	Late laparoscopic cholecystectomy	Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)

Primary Outcome Measures

Name	Time	Method
Number of participants and Rate of Post-operative complications	30 days post-operatively	Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate

Secondary Outcome Measures

Name	Time	Method
Number of participants and Rate of Conversion to open cholecystectomy	from the start till the end of surgical procedure	Number of participants and Rate of Conversion to open cholecystectomy
Mean and Standard deviation of Length of hospital stay (days) (mean±SD)	from hospital admission till home discharge within 30 days	Mean and Standard deviation of Length of hospital stay (days)
Mean and Standard deviation of Operative duration (hours) (mean±SD)	from surgical incision till suture closure	Mean and Standard deviation of Operative duration (hours)
Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)	from surgical incision till suture closure	Mean and Standard deviation of Intra-operative blood loss (ml)

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt