- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744999
HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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CT
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Catania, CT, Italy, 95126
- Isidoro Di carlo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- stage II acute cholecystitis according to the Tokyo guidelines
- symptom onset
Exclusion Criteria:
- stage I cholecystectomy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A new technique of subtotal cholecystectomy
Time Frame: two years
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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.
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two years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDC-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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