NCT05951374

Brief Summary

Laparoscopic cholecystectomy has an increased incidence of extrahepatic biliary injury or bleeding. The common hepatic duct is on the medial border of the Calot triangle and at risk of injury. So, The investigators describe a new safety triangle with a more critical view of safety that is far from dangerous. Retrospectively, from December 2019 until March 2023, the investigators will review the medical records for patients who underwent laparoscopic cholecystectomy. The patients underwent cholecystectomy using a new technique in approaches to critical safety with recorded video and available follow up data were included. The patients who had intraoperatively extensive gallbladder adhesion that interfere with the dissection in this area, improper visualization of the cystic duct, patients whose did not operate by this new technique and patients whose have not video record of laparoscopic cholecystectomy will excluded from the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3.3 years

First QC Date

June 19, 2023

Last Update Submit

July 16, 2023

Conditions

Keywords

Safe Cholecystectomy,critical view of safety.

Outcome Measures

Primary Outcomes (1)

  • Is the extrahepatic bile duct still intact or injurie. How many patients with the Common bile ducts will injurie?

    Is laparoscopic cholecystectomy using Madani triangle technique associated with bile duct injuries or not associated with bile duct injuries or not?

    December 2019 to March 2023

Interventions

After dissection of the proximal part of the gallbladder from its bed and scarification of the cystic artery and its branches, the traction applied to the Hartman pouch created an angle between the skeletonized cystic duct and the skeletonized posterior surface of the GB (Fig. 3). Also, this traction creates a dynamic triangle visualized from both the left and right sides according to the traction applied to the Hartman pouch to the right or left and the direction of the angled scope of the camera lens. From the left-side view, when right traction is applied to the Hartman pouch, it is bound laterally by the skeletonized proximal part of the cystic duct. Superiorly, it is bound by the posterior surface of the proximal part of the skeletonized gallbladder. It was bounded medially by an imaginary line between a point at the junction of the cystic duct with the CBD and a point at the anterior end of the dissected cystic plate (the Madany triangle)

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients male or female , adult or child underwent laparoscopic cholecystectomy using a new visualized technique Madani triangle

You may qualify if:

  • Patients with acute or chronic gall bladder dieses and managed by laparoscopic cholecystectomy.
  • Patients undergo laparoscopic cholecystectomy using Madani triangle approaches.

You may not qualify if:

  • The patients who had intraoperatively extensive gallbladder adhesion.
  • Patients managed by open surgical cholecystectomy approaches not laparoscopic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan university

Aswān, Aswan Governorate, 11331, Egypt

Location

MeSH Terms

Conditions

CholecystitisGallstones

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah M Abdelmohsen, Lecturer

    Aswan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 19, 2023

First Posted

July 19, 2023

Study Start

December 1, 2019

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Madani triangle is a new visualized triangle for laparoscopic cholecystectomy

Shared Documents
STUDY PROTOCOL
Time Frame
December 2019- March 2023
Access Criteria
Herein, we describe another triangle with a CVS because the dissection and cauterization of the cystic artery are in the area of the proximal part of the cystic duct (CD) at its junction with the gallbladder (GB) neck, away from the common bile duct (CBD) and right hepatic artery. So, the surgical steps are far from the CT and its medial structure boundary.

Locations