| CTRI Number |
CTRI/2022/02/040648 [Registered on: 25/02/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of the structure and possible applications of falciform ligament and round ligament of the liver |
|
Scientific Title of Study
|
A study of the surgical anatomy and applications of falciform/ hepatic round ligament |
| Trial Acronym |
HRL Anatomy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramanathan Saranga Bharathi |
| Designation |
Lt Col GI Surgeon |
| Affiliation |
Armed Forces Medical Services |
| Address |
Dept of GI Surgery
Command Hospital Northern Command
Udhampur
Jammu and Kashmir
Udhampur
JAMMU & KASHMIR
182101
India |
| Phone |
8554061554 |
| Fax |
|
| Email |
sarangabharathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramanathan Saranga Bharathi |
| Designation |
Lt Col GI Surgeon |
| Affiliation |
Armed Forces Medical Services |
| Address |
Dept of GI Surgery
Command Hospital Northern Command
Udhampur
Jammu and Kashmir
JAMMU & KASHMIR
182101
India |
| Phone |
8554061554 |
| Fax |
|
| Email |
sarangabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Col AK Dabas |
| Designation |
Col Senior Advisor and administrative officer |
| Affiliation |
Armed Forces Medical Services |
| Address |
Surgical Division
Command Hospital Northern Command
Udhampur
Jammu and Kashmir
Udhampur
JAMMU & KASHMIR
182101
India |
| Phone |
8130830066 |
| Fax |
|
| Email |
ajay13dabas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Using existing resources of Command Hospital Northern Command |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Services |
| Address |
Command Hospital Northern Command
Raghunathpura
Udhampur
Jammu and Kashmir
182101 |
| Type of Sponsor |
Other [Tertiary care teaching hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Col AK Dabas |
Command Hospital Northern Command |
Dept of GI Surgery
Surgical Division
Room Number 2
Raghunathpura
Udhampur
JAMMU & KASHMIR |
8130830066
ajay13dabas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Command Hospital Northern Command |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients under going laparoscopic surgery
Patients undergoing falciform/ round ligament flap procedure
Patients undergoing hepatic-bilio- pancreatic surgeries
Patient needing excision of round ligament/ falciform ligament |
|
| ExclusionCriteria |
| Details |
Peritonitis
Previously excised faliciform/ round ligament previously
Unwilling for the study
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Size
Thickness
Extent
Distensibility
Extent of lumen
Histology
Endothelium |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Applications of falciform and round ligament in abdominal surgery |
2 weeks
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Applications of hepatic round ligament/falciform ligament flap and graft in abdominal surgery—a review of their utility and efficacy. Langenbecks Archives of Surgery 2021; 406: 1249–1281. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Falciform and hepatic round ligament have numerous applications in abdominal surgery but are used infrequently. They have dual vasculature from systemic and portal systems lending more applications possible. However, their anatomy is controversial such as the exact length, thickness, pattern of vasculature, histology, presence and type of endothelium, distensibility, cannulability etc. With the advent of laparoscopy such of gross anatomy can e studies without invasion and with IHC techniques the controversy regarding the endothelium can be put to rest. The extent of luminal distensibility and cannulability can be addressed in specimens that are excised for various reasons. |