Anatomical Variation in Rouvière's Sulcus

July 2, 2024 updated by: Roberto Cirocchi, University Of Perugia

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Laparoscopic cholecystectomy

Description

Inclusion Criteria:

  • Patients undergoing videolaparoscopic cholecystectomy

Exclusion Criteria:

  • 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.

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
Videolaparoscopic cholecystectomy
Patients undergoing Videolaparoscopic cholecystectomy
Evaluation of Rouvière's Sulcus Anatomical Variation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Rouvière's Sulcus
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 2 years
Time expressed in minutes
2 years
Biliary tract injuries
Time Frame: 2 years
Biliary tract injuries according to Stewart's classification.
2 years
Vascular injuries
Time Frame: 2 years
Vascular injuries.
2 years

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

June 10, 2023

First Submitted That Met QC Criteria

June 10, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

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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