Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (ACC)

May 25, 2020 updated by: Ayman El Nakeeb, Mansoura University

Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 356111
        • Mohamed Attea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ACC patients who underwent early LC

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: from the onset of symptoms within the first 3 days (group 1)
ELC for ACC from the onset of symptoms within the first 3 days (group 1)
Procedure: from the onset of symptoms within the first 3 days
ELC within 3 days of onset of ACC
Other Names:
  • group 1
Active Comparator: from the onset of symptoms within the 4-7 days
ELC for ACC from the onset of symptoms within the4-7 days (group II)
Procedure: : from the onset of symptoms within the 4-7 days
ELC 4-7days of onset of ACC
Other Names:
  • Group II
Active Comparator: from the onset of symptoms beyond 7 days
ELC for ACC from the onset of symptoms beyond 7 days (group III)
Procedure: from the onset of symptoms beyond 7 days
ELC after 7days of onset of ACC
Other Names:
  • Group III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of postoperative morbidity
Time Frame: 30 DAYS
the incidence of postoperative morbidity during the 30th day of postoperative procedure
30 DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
conversion rate
Time Frame: INTRAOPERATIVE
conversion rate to open cholecystectomy
INTRAOPERATIVE
blood loss
Time Frame: intraoperative
blood loss
intraoperative
hospital stay
Time Frame: 30 days
overall hospital stay
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ayman E Nakeeb, Mansoura University, Gastrointestinal Surgery Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 25, 2020

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • early LC for ACC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

plan to make individual participant data (

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

elnakeebayman@yahoo.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Study Protocol
    Information identifier: Ayman El Nakeeb
    Information comments: elnakeebayman@yahoo.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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