A (5-5-5-8) Technique for Laparoscopic Cholecystectomy

April 12, 2025 updated by: ClinAmygate
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

The study has two analyses:

  1. at 6 month follow up
  2. at 24 months follow up

Study Type

Interventional

Enrollment (Actual)

524

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
      • Aswan, Egypt
        • Aswan University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged > 18 years
  • Patients eligible for LC during the study period

Exclusion Criteria:

  • refused to participate

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-5-5-8 group
In this group, the new 5-5-5-8 technique of laparoscopic cholecystectomy will be done.
Procedure: 5-5-5-8 technique
the new technique of 5-5-5-8 for laparoscopic cholecystectomy
Active Comparator: Control
In this group, the 10-10-5-5 technique of laparoscopic cholecystectomy will be done.
Procedure: 10-10-5-5 technique
the standard technique of 10-10-5-5 for laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the operation
Time Frame: 1 hour
Duration of the operation in minutes
1 hour
Number of participants with Conversion to open surgery
Time Frame: 1 hour
Number of participants with Failure of the technique and conversion to open surgery
1 hour
Incidence of intra operative visceral injury
Time Frame: 2 hours
Incidence of intra operative visceral injury
2 hours
intra operative amount of blood loss
Time Frame: 2 hours
intra operative amount of blood loss in ml
2 hours
incidence of intra operative complications
Time Frame: 2 hours
incidence of intra operative complications
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of port site infection
Time Frame: 1 month
incidence of infection of the port site
1 month
post operative stay
Time Frame: 1 week
post operative stay in days
1 week
Incidence of port site hernia
Time Frame: 6 months
Incidence of hernia of the port site
6 months
Incidence of port site hernia
Time Frame: 12 months
Incidence of hernia of the port site
12 months
Incidence of port site hernia
Time Frame: 24 months
Incidence of hernia of the port site
24 months

Collaborators and Investigators

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

Sponsor

ClinAmygate

Collaborators

Aswan University Hospital

Investigators

  • Principal Investigator: Mohie El-Din M Madani, MD, Aswan University Hospital

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)

September 20, 2023

Primary Completion (Actual)

September 20, 2024

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR00C1947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared after approval of the IRB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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