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

Primary Purpose

Cholecystitis; Gallstone, Cholecystolithiasis, Cholecystitis, Chronic

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

5-5-5-8 technique

10-10-10-5 technique

About this trial

This is an interventional treatment trial for Cholecystitis; Gallstone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged > 18 years Patients eligible for LC during the study period Exclusion Criteria: refused to participate

Sites / Locations

Aswan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5-5-5-8 group

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Duration of the operation

Duration of the operation in minutes

Number of participants with Conversion to open surgery

Number of participants with Failure of the technique and conversion to open surgery

Secondary Outcome Measures

incidence of port site infection

incidence of infection of the port site

Incidence of port site hernia

Incidence of hernia of the port site

Full Information

NCT ID

NCT06045546

First Posted

September 11, 2023

Last Updated

September 20, 2023

Sponsor

ClinAmygate

Collaborators

Aswan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06045546

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2023 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ClinAmygate

Collaborators

Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystitis; Gallstone, Cholecystolithiasis, Cholecystitis, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5-5-5-8 group

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

5-5-5-8 technique

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

10-10-10-5 technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of the operation

Description

Duration of the operation in minutes

Time Frame

1 hour

Title

Number of participants with Conversion to open surgery

Description

Number of participants with Failure of the technique and conversion to open surgery

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

incidence of port site infection

Description

incidence of infection of the port site

Time Frame

1 month

Title

Incidence of port site hernia

Description

Incidence of hernia of the port site

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged > 18 years Patients eligible for LC during the study period Exclusion Criteria: refused to participate

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohie El-Din M Madani, MD

Phone

01141341342

Mohie.madany@med.aswu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Emad R Issak, MSc

Phone

01066208065

emangate@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohie El-Din M Madani, MD

Organizational Affiliation

Aswan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aswan University Hospital

City

Aswan

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohie El-Din M Madany, MD

Phone

01141341342

Mohie.madany@med.aswu.edu.eg

First Name & Middle Initial & Last Name & Degree

Mohie El-Din M Madany, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will be shared after approval of the IRB

Learn more about this trial

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

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