Anatomical Variation in Rouvière's Sulcus

Sponsor
University Of Perugia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05912894
Collaborator
Giovanni Domenico Tebala (Other), Luca Properzi (Other), Stefano Avenia (Other), Nereo Vettoretto (Other)
1,000
24

Study Details

Study Description

Brief 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. In literature there's an high variability about Rouvière Sulcus prevalence and its anatomical variants.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Videolaparoscopic cholecystectomy

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

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Anatomical Variation in Rouvière's Sulcus: a Cross-sectional Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Videolaparoscopic cholecystectomy

Patients undergoing Videolaparoscopic cholecystectomy

Procedure: Videolaparoscopic cholecystectomy
Evaluation of Rouvière's Sulcus Anatomical Variation.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of Rouvière's Sulcus [2 years]

  2. Anatomical variations in Rouvière's Sulcus [2 years]

    The variants of the Rouvière's Sulcus are catheghorized by the classification of Singh e Prasad.

Secondary Outcome Measures

  1. Operative time [2 years]

    Time expressed in minutes

  2. Biliary tract injuries [2 years]

    Biliary tract injuries according to Stewart's classification.

  3. Vascular injuries [2 years]

    Vascular injuries.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Of Perugia
  • Giovanni Domenico Tebala
  • Luca Properzi
  • Stefano Avenia
  • Nereo Vettoretto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Roberto Cirocchi, Associate Professor in General Surgery, University Of Perugia
ClinicalTrials.gov Identifier:
NCT05912894
Other Study ID Numbers:
  • AVRS1
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Roberto Cirocchi, Associate Professor in General Surgery, University Of Perugia

Study Results

No Results Posted as of Jun 23, 2023