CholecystectomyNCT05744999
HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS
An observational study of Cholecystectomy, run by University of Catania at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Coconut technique
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- All sexes
- Child, Adult
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.
Who may be able to join
- stage II acute cholecystitis according to the Tokyo guidelines
- symptom onset
Who cannot join
- stage I cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cholecystectomy
- Being tested
- Coconut technique
- Keywords
- acute cholecystitis, cholecystectomy, cystic duct
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Coconut technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2021
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidoro Di Carlo, MD, PhD, FACS, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744999
- Sponsor's protocol ID
- IDC-002
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE COCONUT TECHNIQUE - A NEW METHOD TO PERFORM SAFE CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS: Our Initial Experience
- ClinicalTrials.gov ID
- NCT05744999
- Acronym / sponsor ID
- IDC-002
- Conditions
- Cholecystectomy
- Keywords
- acute cholecystitis, cholecystectomy, cystic duct
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the reported technique | – | Procedure: Coconut techniqueTwo 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 |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- stage II acute cholecystitis according to the Tokyo guidelines
- symptom onset
Key exclusion criteria (1 listed)
- stage I cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut techniqueWe 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. | Procedure or surgery | Patients treated with the reported technique |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A new technique of subtotal cholecystectomy (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.