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

NCT06045546 | Active Not Recruiting DMC

• 1 other identifier: PR00C1947
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis; Gallstone; Cholecystolithiasis; Cholecystitis, Chronic

Outcome Measures

Primary Outcomes (5)

• Duration of the operation

  Duration of the operation in minutes

  1 hour

• Number of participants with Conversion to open surgery

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

  1 hour

• Incidence of intra operative visceral injury

  Incidence of intra operative visceral injury

  2 hours

• intra operative amount of blood loss

  intra operative amount of blood loss in ml

  2 hours

• incidence of intra operative complications

  incidence of intra operative complications

  2 hours

Secondary Outcomes (5)

• post operative stay

  1 week

• incidence of port site infection

  1 month

• Incidence of port site hernia

  6 months

• Incidence of port site hernia

  12 months

• Incidence of port site hernia

  24 months

Study Arms (2)

5-5-5-8 group

EXPERIMENTAL

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

Procedure: 5-5-5-8 technique

Control

ACTIVE COMPARATOR

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

Procedure: 10-10-5-5 technique

Interventions

5-5-5-8 technique PROCEDURE

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

5-5-5-8 group

10-10-5-5 technique PROCEDURE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• refused to participate

Sponsors & Collaborators

• ClinAmygate: lead
• Aswan University Hospital: collaborator

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

MeSH Terms

Conditions

Cholecystitis; Gallstones; Cholecystolithiasis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohie El-Din M Madani, MD

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: September 20, 2023
• Primary Completion: September 20, 2024
• Study Completion (Estimated): September 20, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)