HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS

March 1, 2023 updated by: Isidoro Di Carlo, MD, PhD, FACS, University of Catania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • CT
      • Catania, CT, Italy, 95126
        • Isidoro Di carlo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 50 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two females and 1 male with a mean age of 50 years were diagnosed by CT scan with stage II acute cholecystitis according to the Tokyo guidelines and were operated on within three days of symptom onset.

Description

Inclusion Criteria:

  • stage II acute cholecystitis according to the Tokyo guidelines
  • symptom onset

Exclusion Criteria:

- stage I cholecystectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with the reported technique
Two females and 1 male with a mean age of 50 years were diagnosed by CT scan with stage II acute cholecystitis according to the Tokyo guidelines and were operated on within three days of symptom onset
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A new technique of subtotal cholecystectomy
Time Frame: two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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