Madany Triangle; a New Era of Laparoscopic Cholecystectomy

• ClinicalTrials.gov Identifier: NCT05951374
• Recruitment Status: Completed
• First Posted: July 19, 2023
• Last Update Posted: July 19, 2023
• Sponsor: Aswan University Hospital
• Information provided by (Responsible Party): Sarah Magdy Abdelmohsen, Aswan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Laparoscopic Cholecystectomy; Cholecystitis; Gallstone	Procedure: Madany triangle

Detailed Description:

Operative procedure:

This technique was different from the ordinary laparoscopic cholecystectomy in the following steps: with the aid of electrocautery Hook, the dissection started first with the peritoneum, which covered both sides of the Hartman pouch, the proximal third of the gallbladder (the area of the gallbladder at its neck), and the proximal part of the cystic duct (the end of the cystic duct which was attached to the gallbladder neck).

With using a grasper for manipulating the Hartman pouch for better dissection of the gallbladder bed. Then gently dissecting the gallbladder from its bed to skeletonize it away from the cystic plate and porta hepatis. The small branches of cystic artery that were dipping in the GB wall were cauterized one by one. This step involved scarification of the cystic artery, and its branches, which necessitated the use of bipolar diathermy.

Now, 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.

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).

From the right-side view, when left traction was applied on the Hartman pouch, the triangle was bounded by the proximal part of the dissected cystic duct medially. It was bound superiorly by the posterior surface of the proximal third of the skeletonized gallbladder. Laterally, it was bounded by an imaginary line between a point at the junction of the cystic duct with the CBD and another point located at the anterior end of the dissected cystic plate.

A Vicryl (2-0) ligature or a titanium clip was applied to the cystic duct immediately distal to the Hartman pouch after gentle milking of the cystic duct to exclude the presence of stones inside. The GB was removed from the peritoneal cavity with the use of a bag.

Study Design

• Study Type: Observational
• Actual Enrollment: 238 participants
• Observational Model: Case-Crossover
• Time Perspective: Retrospective
• Official Title: Madany Triangle; a New Era of Laparoscopic Cholecystectomy
• Actual Study Start Date: December 1, 2019
• Actual Primary Completion Date: March 30, 2023
• Actual Study Completion Date: March 30, 2023

Groups and Cohorts

Intervention Details:

• Procedure: Madany triangle

  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)

Outcome Measures

Primary Outcome Measures :

1. Is the extrahepatic bile duct still intact or injurie. How many patients with the Common bile ducts will injurie? [ Time Frame: December 2019 to March 2023 ]
   Is laparoscopic cholecystectomy using Madani triangle technique associated with bile duct injuries or not associated with bile duct injuries or not?

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Egypt

Aswan university

Aswan, Aswan Governorate, Egypt, 11331

Sponsors and Collaborators

Aswan University Hospital

Investigators

• Principal Investigator: Sarah M Abdelmohsen, Lecturer; Aswan University

More Information

• Responsible Party: Sarah Magdy Abdelmohsen, Lecturer, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT05951374
• Other Study ID Numbers: AswanUH6
• First Posted: July 19, 2023
• Last Update Posted: July 19, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Madani triangle is a new visualized triangle for laparoscopic cholecystectomy
• Supporting Materials: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sarah Magdy Abdelmohsen, Aswan University Hospital:

Safe Cholecystectomy,; critical view of safety.

Additional relevant MeSH terms:

Cholecystitis; Gallstones; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical