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

N/AActive Not RecruitingNCT06045546

ClinAmygate524 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

524

Conditions

Cholecystitis; Gallstone Cholecystolithiasis Cholecystitis, Chronic

Interventions

5-5-5-8 techniquePROCEDURE

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

10-10-5-5 techniquePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University Hospital

Aswān, Egypt

Outcomes

Primary Outcomes

Duration of the operation

Duration of the operation in minutes

Time frame: 1 hour

Number of participants with Conversion to open surgery

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

Time frame: 1 hour

Incidence of intra operative visceral injury

Time frame: 2 hours

intra operative amount of blood loss

intra operative amount of blood loss in ml

Time frame: 2 hours

incidence of intra operative complications

Time frame: 2 hours

Secondary Outcomes

post operative stay

post operative stay in days

Time frame: 1 week

incidence of port site infection

incidence of infection of the port site

Time frame: 1 month

Incidence of port site hernia

Incidence of hernia of the port site

Time frame: 6 months

Incidence of port site hernia

Incidence of hernia of the port site

Time frame: 12 months

Data from ClinicalTrials.gov

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