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

NCT ID: NCT06045546

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2026-09-20

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cholecystitis; Gallstone Cholecystolithiasis Cholecystitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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5-5-5-8 group

In this group, the new 5-5-5-8 technique of laparoscopic cholecystectomy will be done.

Group Type EXPERIMENTAL

5-5-5-8 technique

Intervention Type PROCEDURE

the new technique of 5-5-5-8 for laparoscopic cholecystectomy

Control

In this group, the 10-10-5-5 technique of laparoscopic cholecystectomy will be done.

Group Type ACTIVE_COMPARATOR

10-10-5-5 technique

Intervention Type PROCEDURE

the standard technique of 10-10-5-5 for laparoscopic cholecystectomy

Interventions

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5-5-5-8 technique

the new technique of 5-5-5-8 for laparoscopic cholecystectomy

Intervention Type PROCEDURE

10-10-5-5 technique

the standard technique of 10-10-5-5 for laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refused to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role collaborator

ClinAmygate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohie El-Din M Madani, MD

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PR00C1947

Identifier Type: -

Identifier Source: org_study_id

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