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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05002426
Other study ID # 1458
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date October 1, 2021

Study information

Verified date August 2021
Source The Second Hospital of Anhui Medical University
Contact lei wang, MD
Phone +8615156086983
Email wl9252@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Hepatic hilum plane is the hepatoduodenal serosa plane that extends from the base of the liver IVa segment down to the first segment of the gallbladder triangle. During the operation, first pulling the gallbladder to the head side, using the separating forceps to slide down horizontally from the hilum (the basement of hepatic segment Ⅳ), and along the serous of hepatoduodenal ligament, that is so called "hilum plane". It forms a "neck-shoulder" structure when the hilar plane meets the tent-like hepatobiliary triangle. the serosa of hepatobiliary triangle was dissected on the neck area and ventral side of hilar plane, and the serosa of posterior triangle of the gallbladder was also cutted on the same extension line . In this process, the type and orientation of RS, the relationship between the plane of the RS sulcus and the plane of the hilar plane were also recorded and compared with hilum plane.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Benign disease of the gallbladder requires surgery Exclusion Criteria: Patients with severe cirrhosis or had a history of partial hepatectomy were excluded from the statistics . patients with unexpected gallbladder carcinoma.

Study Design


Locations

Country Name City State
China Lei Wang Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
The Second Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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