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CompletedNCT05744999Updated Mar 3, 2023

HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS

An observational study in Cholecystectomy, sponsored by University of Catania. Completed at 1 site in Italy. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-03.

Sponsored by University of Catania · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
3
Ages
Up to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cholecystectomy

Keywords

  • acute cholecystitis
  • cholecystectomy
  • cystic duct
03

In context

Cholecystitis

266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's enrollment of 3 is below the median of 200 across 90 observational studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

University of Catania is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • stage I cholecystectomy
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
3 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Procedure: Coconut technique

Interventions

  • ProcedureCoconut 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: two years

07

Study locations

1 site
  • Isidoro Di carlo
    Catania, CT 95126, Italy
08

References and documents

Study documents

  • Study protocol · Feb 2, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05744999
Lead sponsor
University of Catania
Responsible party
Isidoro Di Carlo, MD, PhD, FACS (Professor, University of Catania) — Principal investigator
First posted
Feb 27, 2023
Start date
Jan 1, 2021
Primary completion
Dec 1, 2022
Completion
Feb 1, 2023
Last update
Mar 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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