Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

Not Applicable

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: from the onset of symptoms within the first 3 days; Procedure: from the onset of symptoms beyond 7 days

• Registration Number: NCT04405713
• Lead Sponsor: Mansoura University

Brief Summary

The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy

Detailed Description

This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-25
• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Last Update Submitted: 2020-05-25
• Study First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

ACC patients who underwent early LC

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Exclusion Criteria

Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
from the onset of symptoms within the first 3 days (group 1)	from the onset of symptoms within the first 3 days	ELC for ACC from the onset of symptoms within the first 3 days (group 1)
from the onset of symptoms beyond 7 days	from the onset of symptoms beyond 7 days	ELC for ACC from the onset of symptoms beyond 7 days (group III)

Primary Outcome Measures

Name	Time	Method
the incidence of postoperative morbidity	30 DAYS	the incidence of postoperative morbidity during the 30th day of postoperative procedure

Secondary Outcome Measures

Name	Time	Method
blood loss	intraoperative	blood loss
conversion rate	INTRAOPERATIVE	conversion rate to open cholecystectomy
hospital stay	30 days	overall hospital stay

Trial Locations

Locations (1)

Mohamed Attea; 🇪🇬 Mansoura, Egypt