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

• Sponsor: ClinAmygate (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06045546
• Collaborator: Aswan University Hospital (Other)
• Enrollment: 480
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.9
• Patients Per Site Per Month: 98.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cholecystitis; Gallstone; Cholecystolithiasis; Cholecystitis, Chronic	Procedure: 5-5-5-8 technique; Procedure: 10-10-10-5 technique	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A (5-5-5-8) Technique for Laparoscopic Cholecystectomy
• Actual Study Start Date: Sep 20, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Feb 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5-5-5-8 group In this group, the new 5-5-5-8 technique of laparoscopic cholecystectomy will be done.	Procedure: 5-5-5-8 technique; the new technique of 5-5-5-8 for laparoscopic cholecystectomy
Active Comparator: Control In this group, the 10-10-5-5 technique of laparoscopic cholecystectomy will be done.	Procedure: 10-10-10-5 technique; the standard technique of 10-10-10-5 for laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

1. Duration of the operation [1 hour]

   Duration of the operation in minutes

2. Number of participants with Conversion to open surgery [1 hour]

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

Secondary Outcome Measures

1. incidence of port site infection [1 month]

   incidence of infection of the port site

2. Incidence of port site hernia [6 weeks]

   Incidence of hernia of the port site

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged > 18 years

• Patients eligible for LC during the study period

Exclusion Criteria:

• refused to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt

Sponsors and Collaborators

• ClinAmygate
• Aswan University Hospital

Investigators

• Principal Investigator: Mohie El-Din M Madani, MD, Aswan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ClinAmygate
• ClinicalTrials.gov Identifier: NCT06045546
• Other Study ID Numbers: PR00C1947
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholecystitis; Acalculous Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis

Study Results

No Results Posted as of Sep 21, 2023