MedTrace Logo

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

NCT03999645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-06-27

No results posted yet for this study

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

Interventions

PROCEDURE

Early laparoscopic cholecystectomy

within 72h from symptom onset

PROCEDURE

Late laparoscopic cholecystectomy

after 72h up to seven days from symptom onset

Sponsors & Collaborators

  • Damanhour Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Mohamed M Abdalgaleil, MD · Damanhour Teaching Hospital

  • Ahmed M Shaat, MD · Damanhour Teaching Hospital

  • Osama S Elbalky, MD · Damanhour Teaching Hospital

  • Mamdouh M Ibrahim, MD · Damanhour Teaching Hospital

  • Mohamed S Elnagar, MD · Damanhour Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999645 on ClinicalTrials.gov