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OpenTrials
Active, Not Recruiting

NCT Number: NCT06045546

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cholecystitis; Gallstone Biliary Tract Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Calculi Cholecystitis Cholecystitis, Chronic Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospital

Aswān, Egypt

About this study

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:

  • at 6 month follow up
  • at 24 months follow up

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • refused to participate

Treatment and study plan

5-5-5-8 technique

Procedure

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

10-10-5-5 technique

Procedure

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

Primary outcomes

  1. Duration of the operation

    Time frame: 1 hour

    Duration of the operation in minutes

  2. 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

  3. Incidence of intra operative visceral injury

    Time frame: 2 hours

    Incidence of intra operative visceral injury

  4. intra operative amount of blood loss

    Time frame: 2 hours

    intra operative amount of blood loss in ml

  5. incidence of intra operative complications

    Time frame: 2 hours

    incidence of intra operative complications

Secondary outcomes

  1. post operative stay

    Time frame: 1 week

    post operative stay in days

  2. incidence of port site infection

    Time frame: 1 month

    incidence of infection of the port site

  3. Incidence of port site hernia

    Time frame: 6 months

    Incidence of hernia of the port site

  4. Incidence of port site hernia

    Time frame: 12 months

    Incidence of hernia of the port site

  5. Incidence of port site hernia

    Time frame: 24 months

    Incidence of hernia of the port site

Sponsors and collaborators

Lead sponsor

ClinAmygate

Other

Collaborators

  • Aswan University Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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