HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS

Cholecystectomy Clinical Trial

Official title:

THE COCONUT TECHNIQUE - A NEW METHOD TO PERFORM SAFE CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS: Our Initial Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05744999
• Other study ID #: IDC-002
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this manuscript is to illustrate a new method permitting safe cholecystectomy in terms of complications with respect to the common bile duct (CBD).

The core of this new technique is identification of the continuity of the cystic duct with the infundibulum. The cystic duct can be identified between the inner gallbladder wall and inflamed outer wall.

In the last 2 years, 3 patients have been treated with the reported technique without complications.

Among the various cholecystectomy procedures, this is a new approach that ensures the safety of the structures of Calot's triangle while providing the advantages gained from total removal of the gallbladder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: N/A to 50 Years

Eligibility

Inclusion Criteria:

• stage II acute cholecystitis according to the Tokyo guidelines

• symptom onset

Exclusion Criteria:

• stage I cholecystectomy

Related Conditions & MeSH terms

• Cholecystectomy
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Coconut technique
We recently developed a simple but effective laparoscopic technique to approach and ligate the cystic duct in cases of difficult acute cholecystitis. Three to four centimeters of the inflamed gallbladder wall was then cut using an electrocautery hook. An incision was made in a safe zone at the junction of the infundibulum and the body of the gallbladder. The separation between the outer layer and inner layer was searched. This clear identification of the confluence between the cystic duct and the body of the gallbladder represents the way to determine if the procedure was safely completed using the current technique. After successful identification, the cystic duct was clipped. The gallbladder can then be lifted and turned over, leaving the unidentified CBD untouched, and cholecystectomy can be carefully performed as usual. The inflamed posterior wall remained attached to the gallbladder bed of the liver.

Locations

Country	Name	City	State
Italy	Isidoro Di carlo	Catania	CT

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A new technique of subtotal cholecystectomy	Three to four centimeters of the inflamed gallbladder wall was then cut using an electrocautery hook. An incision was made in a safe zone at the junction of the infundibulum and the body of the gallbladder. The separation between the outer layer and inner layer was searched. This clear identification of the confluence between the cystic duct and the body of the gallbladder represents the way to determine if the procedure was safely completed using the current technique. After successful identification, the cystic duct was clipped.	two years