Laparoscopic CholecystectomyNCT05951374
Madany Triangle; a New Era of Laparoscopic Cholecystectomy
An observational study of Laparoscopic Cholecystectomy and Cholecystitis; Gallstone, run by Aswan University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Cholecystitis; Gallstone
- What is being tested?
- Madany triangle
- Type of treatment
- Surgery or procedure
- How many people
- 238 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: all patients male or female , adult or child underwent laparoscopic cholecystectomy using a new visualized technique Madani triangle
Who may be able to join
- Patients with acute or chronic gall bladder dieses and managed by laparoscopic cholecystectomy.
- Patients undergo laparoscopic cholecystectomy using Madani triangle approaches.
Who cannot join
- The patients who had intraoperatively extensive gallbladder adhesion.
- Patients managed by open surgical cholecystectomy approaches not laparoscopic.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Madany triangle
- Keywords
- Safe Cholecystectomy,, critical view of safety.
- Medical subject headings
- Cholecystitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Madany triangleProcedure or surgery
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: December 2019 to March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Dec 2019
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Magdy Abdelmohsen, Aswan University Hospital
- Investigators
- Sarah M Abdelmohsen, Lecturer, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951374
- Sponsor's protocol ID
- AswanUH6
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Madani triangle is a new visualized triangle for laparoscopic cholecystectomy
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Madany Triangle; a New Era of Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05951374
- Acronym / sponsor ID
- AswanUH6
- Keywords
- Safe Cholecystectomy,, critical view of safety.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients male or female , adult or child underwent laparoscopic cholecystectomy using a new visualized technique Madani triangle
Key inclusion criteria (2 listed)
- Patients with acute or chronic gall bladder dieses and managed by laparoscopic cholecystectomy.
- Patients undergo laparoscopic cholecystectomy using Madani triangle approaches.
Key exclusion criteria (2 listed)
- The patients who had intraoperatively extensive gallbladder adhesion.
- Patients managed by open surgical cholecystectomy approaches not laparoscopic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Madany triangleAfter 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) | Procedure or surgery | – |
Primary outcome
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: Yes. Madani triangle is a new visualized triangle for laparoscopic cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M Abdelmohsen, Lecturer principal investigator
Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Cholecystitis; Gallstone, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.