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

Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Cholecystitis
• Intervention / Treatment: Procedure: Early laparoscopic cholecystectomy; Procedure: Late laparoscopic cholecystectomy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Beheira
    • Damanhūr, El-Beheira, Egypt
      • Damanhour Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group E: Early LC (n=60); Early laparoscopic cholecystectomy (within 72h from symptom onset)	Procedure: Early laparoscopic cholecystectomy; within 72h from symptom onset
Active Comparator: Group L: Late LC (n=60); Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)	Procedure: Late laparoscopic cholecystectomy; after 72h up to seven days from symptom onset

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Damanhour Teaching Hospital
• Investigators: Principal Investigator: Mohamed M Abdalgaleil, MD, Damanhour Teaching Hospital; Study Director: Osama S Elbalky, MD, Damanhour Teaching Hospital; Study Chair: Mamdouh M Ibrahim, MD, Damanhour Teaching Hospital; Study Chair: Mohamed S Elnagar, MD, Damanhour Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Acute cholecystitis; Early laparoscopic cholecystectomy; Gallbladder disease; Late laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: DTH:19002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No