Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle

Body First Approach in Laparoscopic Cholecystectomy in Cases With Obscure Calot's Triangle

The aim of this study is to evaluate the body first approach on the rate of conversion to open technique & VBI in patients with obscure calot's triangle.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis, Chronic
• Intervention / Treatment: Device: Lap cholecystectomy

Detailed Description

Gallbladder disease is one of the most common reasons patients are referred to a general surgeon. Laparoscopic cholecystectomy (LC) is the current standard of care for symptomatic cholelithiasis. Despite being considered a low-risk surgery, bile duct injuries (BDIs) have occurred at a constant rate in the last 30 years, leaving devastating consequences on the affected patients. However vasculobiliary injury (VBI) is a rare but critical complication of (LC). So we need to follow critical view of safety. The critical view of safety (CVS) described by Strasberg is considered as the one of the most important critical factors for overall safety during LC. The CVS consists of three essential component or steps: 1) dissection of the hepatocystic triangle (HCT); 2) exposure of at least lower one third of the cystic plate (CP); and 3) demonstration of only two tubular structures (cystic duct and cystic artery) that remain attached to the gallbladder (after components 1 and 2 are achieved). All these three steps must be completed before considering that CVS has been achieved. However in some cases Calot's triangle can't be demonstrated due to dense adhesions. Conversion with retrograde approach (fundus first) was an option for these cases. However a retrograde approach can be achieved laparoscopically by starting dissection by body to use the fundus attachment for retraction which is called (the "body-first approach") that may decrease the possibility of VBI. Recent studies deficient in evaluation of outcome of (body first approach). So the interest of our study is to evaluate the outcome of body first approach in difficult cases and cases with obscure Calot's triangle in (LC) and to evaluate its feasibility and safety in (LC).

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Abdelrahman Abdullah Badawy, Resident; Phone Number: 01010016178; Email: abdobadawy28.ab@gmail.com
• Study Contact Backup: Name: Samir Ahmed Ammar, Professor; Phone Number: 01141459567; Email: Samirahmed22@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All adult patients aging above 18 years old fit for (LC), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure Calot's triangle.

Description

Inclusion Criteria:

- All adult patients aging above 18 years old fit for (LC), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure Calot's triangle.

Exclusion Criteria:

• unfit patients.
• Patients with calcular obstructive jaundice.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe laparoscopic cholecystectomy.	To achieve critical view of safety during lap cholecystectomy	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the body first approach technique	evaluate the body first approach on the rate of conversion to open technique & VBI in patients with obscure calot's triangle.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Laparoscopic cholecystectomy: semi-top-down technique
• Postoperative analgesic effect of ultrasound-guided rectus sheath block and local anesthetic infiltration after laparoscopic cholecystectomy: Results of a prospective randomized controlled trial
• Application of a novel surgical difficulty grading system during laparoscopic cholecystectomy
• Randomized controlled trial comparing the effects of usual gas release, active aspiration, and passive-valve release on abdominal distension in patients who have undergone laparoscopic cholecystectomy
• Body-first approach of laparoscopic cholecystectomy for minimizing vasculobiliary injury: Initial experience
• Laparoscopic Cholecystectomy
• A three-step conceptual roadmap for avoiding bile duct injury in laparoscopic cholecystectomy: an invited perspective review

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): August 8, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: Body first in lap chole

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No