Rouvière's SulcusNCT05912894
Anatomical Variation in Rouvière's Sulcus
An observational study of Rouvière's Sulcus, run by University Of Perugia.
Trial summary
Rouvière's sulcus is a 2-5 cm fissure lying on the lower face of the liver, between the right lobe and caudate process. Due to its extrabiliary location, Rouvière's Sulcus could be used as an anatomical landmark for safe laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rouvière's Sulcus
- What is being tested?
- Videolaparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Laparoscopic cholecystectomy
Who may be able to join
- Patients undergoing videolaparoscopic cholecystectomy
Who cannot join
- If the lower face of the right hepatic lobe and the main elements of the biliary tract cannot be clearly analyzed patients will be excluded.
About this study
Official title: Anatomical Variation in Rouvière's Sulcus: a Cross-sectional Study
Rouvière's sulcus is a 2-5 cm fissure lying on the lower face of the liver, between the right lobe and caudate process. Due to its extrabiliary location, Rouvière's Sulcus could be used as an anatomical landmark for safe laparoscopic cholecystectomy. In literature there's an high variability about Rouvière Sulcus prevalence and its anatomical variants.
Read the detailed description
The goal of this observational study is to evaluate the presence of Rouvière Sulcus in patients underwent laparoscopic cholecystectomy. The main questions it aims to answer are the prevalence and the anatomical variations of Rouvière's Sulcus and the variants of Rouvière's Sulcus which are catheghorized according to Singh and Prasad criteria.
The following were considered secondary outcome: operative time expressed in minutes, biliary tract injuries according to Stewart's classification and Vascular injuries.
- Conditions
- Rouvière's Sulcus
- Being tested
- Videolaparoscopic cholecystectomy
- Keywords
- Prevalence Rouvière's Sulcus, Anatomical variations Rouvière's Sulcus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaparoscopic cholecystectomyProcedure or surgery
Evaluation of Rouvière's Sulcus Anatomical Variation.
| Study group | Role | What they receive |
|---|---|---|
| Videolaparoscopic cholecystectomy | Patients undergoing Videolaparoscopic cholecystectomy Receives: Procedure: Videolaparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Rouvière's Sulcus
Measured: 2 years
Anatomical variations in Rouvière's Sulcus
The variants of the Rouvière's Sulcus are catheghorized by the classification of Singh e Prasad.
Measured: 2 years
Secondary outcomes (3)
Operative time
Time expressed in minutes
Measured: 2 years
Biliary tract injuries
Biliary tract injuries according to Stewart's classification.
Measured: 2 years
Vascular injuries
Vascular injuries.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rouvière's SulcusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Collaborators
- Giovanni Domenico Tebala, Luca Properzi, Nereo Vettoretto, Matteo Matteucci, Antonio Pesce, Carlo Boselli, Antonia Rizzuto, Augusto Lauro
- Responsible party
- Principal investigator, Roberto Cirocchi, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912894
- Sponsor's protocol ID
- AVRS1
- Status last verified
- Jul 2024
- First submitted
- 10 Jun 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh M, Prasad N. The anatomy of Rouviere's sulcus as seen during laparoscopic cholecystectomy: A proposed classification. J Minim Access Surg. 2017 Apr-Jun;13(2):89-95. doi: 10.4103/0972-9941.201731.
PubMed 28281470Stewart L. Iatrogenic biliary injuries: identification, classification, and management. Surg Clin North Am. 2014 Apr;94(2):297-310. doi: 10.1016/j.suc.2014.01.008.
PubMed 24679422Pesce A, Fabbri N, Feo CV. Vascular injury during laparoscopic cholecystectomy: An often-overlooked complication. World J Gastrointest Surg. 2023 Mar 27;15(3):338-345. doi: 10.4240/wjgs.v15.i3.338.
PubMed 37032796
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Variation in Rouvière's Sulcus: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05912894
- Acronym / sponsor ID
- AVRS1
- Conditions
- Rouvière's Sulcus
- Keywords
- Prevalence Rouvière's Sulcus, Anatomical variations Rouvière's Sulcus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Collaborators
- Giovanni Domenico Tebala, Luca Properzi, Nereo Vettoretto, Matteo Matteucci, Antonio Pesce, Carlo Boselli, Antonia Rizzuto, Augusto Lauro
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Jun 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.
Rouvière's sulcus is a 2-5 cm fissure lying on the lower face of the liver, between the right lobe and caudate process. Due to its extrabiliary location, Rouvière's Sulcus could be used as an anatomical landmark for safe laparoscopic cholecystectomy. In literature there's an high variability about Rouvière Sulcus prevalence and its anatomical variants.
Detailed description
The goal of this observational study is to evaluate the presence of Rouvière Sulcus in patients underwent laparoscopic cholecystectomy. The main questions it aims to answer are the prevalence and the anatomical variations of Rouvière's Sulcus and the variants of Rouvière's Sulcus which are catheghorized according to Singh and Prasad criteria.
The following were considered secondary outcome: operative time expressed in minutes, biliary tract injuries according to Stewart's classification and Vascular injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videolaparoscopic cholecystectomy | – | Procedure: Videolaparoscopic cholecystectomyPatients undergoing Videolaparoscopic cholecystectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Laparoscopic cholecystectomy
Key inclusion criteria (1 listed)
- Patients undergoing videolaparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- If the lower face of the right hepatic lobe and the main elements of the biliary tract cannot be clearly analyzed patients will be excluded.
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 |
|---|---|---|
| Videolaparoscopic cholecystectomyEvaluation of Rouvière's Sulcus Anatomical Variation. | Procedure or surgery | Videolaparoscopic cholecystectomy |
Primary outcome
Prevalence of Rouvière's Sulcus
Time frame: 2 years
Anatomical variations in Rouvière's Sulcus
Time frame: 2 years
The variants of the Rouvière's Sulcus are catheghorized by the classification of Singh e Prasad.
3 secondary outcomes
Operative time
Time frame: 2 years
Biliary tract injuries
Time frame: 2 years
Vascular injuries
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 28281470Singh M, Prasad N. The anatomy of Rouviere's sulcus as seen during laparoscopic cholecystectomy: A proposed classification. J Minim Access Surg. 2017 Apr-Jun;13(2):89-95. doi: 10.4103/0972-9941.201731.
- Background: PubMed 24679422Stewart L. Iatrogenic biliary injuries: identification, classification, and management. Surg Clin North Am. 2014 Apr;94(2):297-310. doi: 10.1016/j.suc.2014.01.008.
- Background: PubMed 37032796Pesce A, Fabbri N, Feo CV. Vascular injury during laparoscopic cholecystectomy: An often-overlooked complication. World J Gastrointest Surg. 2023 Mar 27;15(3):338-345. doi: 10.4240/wjgs.v15.i3.338.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rouvière's Sulcus, run by University Of Perugia.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Prevalence of Rouvière's Sulcus (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912894, which also lists 3 linked publications.
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 5 Jul 2024.