Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT06280404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Body First Approach in Laparoscopic Cholecystectomy in Cases With Obscure Calot's Triangle
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: