Gallbladder Infundibulum as a Guide for Ductal Identification.

NCT06239233 | Unknown DMC

• 1 other identifier: 427/2023
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Bile duct injury (BDI) is a catastrophic complication of cholecystectomy, and misidentification of the cystic anatomy is considered to be the main cause. Although several techniques have been developed to prevent BDI, such as the "critical view of safety", the infundibular technique, the rates remain higher during laparoscopic cholecystectomy (LC) than during open surgery. Strategy for ductal identification during laparoscopic cholecystectomy can help to prevent laparoscopic bile duct injury. Methods: A prospective study of 196 patients who will undergo LC during the study period of one year at Nepal Mediciti Hospital will be conducted. The gallbladder infundibulum will be classified by its position located on an imaginary clock with the gallbladder neck as the center point of the dial, 3 o'clock position as cranial, 6 o'clock as dorsal, 9 o'clock as caudal, and 12 o'clock as ventral, as well as the axial position. Patient demographics, pathologic variables and infundibulum classification will be evaluated. Detailed analysis of ductal identification based on gallbladder infundibulum position will be performed in this study. All infundibulum positions will be recorded during intraoperative laparoscopic procedure.

Conditions

Gallstone Disease

Outcome Measures

Primary Outcomes (1)

• The investigator will identify the position of the Hartmann's pouch if present as 12,3,6 and 9 o' clock position. If the Hartmann's pouch is absent, then it will be labelled as axial type. Collected data will be aggregated in percentage.

  Primary outcome involves evaluating the effectiveness of the gallbladder infundibulum as a landmark for identifying and dissecting the bile ducts during the surgical procedure. The success rate could be measured by the proportion of cases in which the gallbladder infundibulum facilitated accurate and safe identification of the ductal structures. Number of participants with successful identification of cystic duct following Hartmann's pouch of Gall bladder infundibulum will be shown in percentage. Linear regression will be used to calculate the association between different position of infundibulum and sucess of identification of cystic duct.

  1 year.

Secondary Outcomes (1)

• Incidence and risk factors associated with post-operative morbidities.

  [Time Frame: 1 year]

Interventions

Laparoscopic cholecystectomy PROCEDURE

The surgeon makes small incisions in the abdominal wall, usually around the navel. Trocars (hollow tubes) are inserted through these incisions to provide access for the laparoscope and specialized instruments. A laparoscope, a thin tube with a light and camera, is inserted through one of the trocars. It allows the surgical team to visualize the abdominal cavity on a monitor. The surgeon carefully identifies the gallbladder and the cystic duct, which connects the gallbladder to the common bile duct. The cystic duct and artery are clipped and cut to disconnect the gallbladder from the biliary system. This step ensures the safe removal of the gallbladder. The surgeon gently detaches the gallbladder from the liver bed and removes it through one of the small incisions. Any bleeding vessels are sealed, and the small incisions are closed with stitches or surgical glue.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy at Nepal Mediciti Hospital.

You may qualify if:

• All the patient undergoing laparoscopic cholecystectomy for gall stone disease above age 18years.

You may not qualify if:

• Patients undergoing Laparoscopic cholecystectomy for Carcinoma Gallbladder.

Sponsors & Collaborators

• Nepal Mediciti Hospital: lead

Study Sites (1)

Nepal Mediciti Hospital

Kathmandu, Central, Nepal

RECRUITING

Related Publications (1)

• Shang P, Liu B, Li X, Miao J, Lv R, Guo W. A practical new strategy to prevent bile duct injury during laparoscopic cholecystectomy. A single-center experience with 5539 cases. Acta Cir Bras. 2020;35(6):e202000607. doi: 10.1590/s0102-865020200060000007. Epub 2020 Jul 8.

  PMID: 32667588 BACKGROUND

Related Links

• A practical new strategy to prevent bile duct injury during laparoscopic cholecystectomy. A single-center experience with 5539 cases.

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Rajiv Mishra, M.S.

  Nepal Mediciti Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajiv Mishra, M.S.

CONTACT

+977-9862198595; rajvmsra@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: February 2, 2024
• Study Start: December 25, 2023
• Primary Completion: October 19, 2024
• Study Completion: October 19, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)