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

Cholecystitis, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280404
• Other study ID #: Body first in lap chole
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: August 8, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Abdelrahman Abdullah Badawy, Resident
• Phone: 01010016178
• Email: abdobadawy28.ab[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 8, 2025
• Est. primary completion date: March 15, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Chronic

Intervention

Device:
• Lap cholecystectomy
Body first approach in laparoscopic cholecystectomy in cases with obscure Calot's triangle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe laparoscopic cholecystectomy.	To achieve critical view of safety during lap cholecystectomy	Baseline
Secondary	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

External Links

•   A three-step conceptual roadmap for avoiding bile duct injury in laparoscopic cholecystectomy: an invited perspective review
•   Application of a novel surgical difficulty grading system during laparoscopic cholecystectomy
•   Body-first approach of laparoscopic cholecystectomy for minimizing vasculobiliary injury: Initial experience
•   Laparoscopic Cholecystectomy
•   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
•   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