NCT05002426

Brief Summary

RS and the RS plane are important anatomical markers in laparoscopic cholecystectomy. However, there are many variations in the shape and orientation of the RS, and the RS plane is an imaginary plane, which can be misjudged by different surgeons. The purpose of this study is to introduce a more intuitive anatomical marker and anatomical plane, hilum plane, and discuss the application value of hilum plane in laparoscopic biliary surgery by comparing it with RS and RS plane.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

August 4, 2021

Last Update Submit

August 4, 2021

Conditions

Keywords

anatomy

Outcome Measures

Primary Outcomes (2)

  • The type of Rouviere sulcus and the "fake RS"

    The Rouviere sulcus was present if a fissure was seen in the liver parenchyma on the right side of the gallbladder and continues with the right posterior hepatic pedicle(fig ). RS were further subdivided into three classes: "open type", "fused type" or "absent type"). The "plane of RS sulcus" was also recorded If the RS was not the absent type.

    up to 30 days after surgery

  • The orientation of RS and The relationship between hepatic portal plane and RS plane

    the RS plane is an imaginary line drawn along the sulcus and carried across to the base of segment IV and form a "security triangle". Similarly, the hilar plane can also form a triangle in posterior triangle of gallbladder. The areas of these triangles were Compared.

    up to 30 days after surgery

Study Arms (1)

The type and orientation of Rouviere sulcus

"open type", "fused type" or "absent type"

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a consecutive patients undergoing elective laparoscopic cholecystectomies at the second affiliated hospital of Anhui medical university

You may qualify if:

  • Benign disease of the gallbladder requires surgery

You may not qualify if:

  • Patients with severe cirrhosis or had a history of partial hepatectomy were excluded from the statistics .
  • patients with unexpected gallbladder carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Wang

Hefei, Anhui, 230601, China

RECRUITING

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • hui hou, master

    Second Affiliated Hospital of Anhui Medical University

    STUDY CHAIR

Central Study Contacts

lei wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Second Hospital of Anhui Medical University

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

January 4, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations