| CTRI Number |
CTRI/2025/01/079106 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational study |
| Study Design |
Other |
|
Public Title of Study
|
INTRAOPERATIVE ANATOMY OF THE BILIARY TRACT: VARIATIONS AND CONGENITAL ANOMALIES AND IMPLICATIONS IN LAPAROSCOPIC CHOLECYSTECTOMY: 1 YEAR OBSERVATIONAL STUDY AT A TERTIARY CARE TEACHING HOSPITAL. |
|
Scientific Title of Study
|
INTRAOPERATIVE ANATOMY OF THE BILIARY TRACT: VARIATIONS AND CONGENITAL ANOMALIES AND IMPLICATIONS IN LAPAROSCOPIC CHOLECYSTECTOMY: 1 YEAR OBSERVATIONAL STUDY AT A TERTIARY CARE TEACHING HOSPITAL IN BELAGAVI REGION OF NORTH KARNATAKA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivangi Singh |
| Designation |
Junior Resident MS General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
JNMC Belagavi KLE University
NEHRU NAGAR
Belgaum
KARNATAKA
590001
India |
| Phone |
6360854775 |
| Fax |
|
| Email |
singh.shivangi14997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR B M Kajagar |
| Designation |
Professor MS General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
JNMC Belagavi KLE University
NEHRU NAGAR
Belgaum
KARNATAKA
590001
India |
| Phone |
8722630285 |
| Fax |
|
| Email |
bmkajagar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR B M Kajagar |
| Designation |
Professor MS General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
JNMC Belagavi KLE University
NEHRU NAGAR
Belgaum
KARNATAKA
590001
India |
| Phone |
8722630285 |
| Fax |
|
| Email |
bmkajagar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| DR Shivangi Singh
Junior Resident
Jawaharlal Nehru Medical College, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Shivangi Singh |
| Address |
Jawaharlal Nehru Medical College, Belagavi, KLE University |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Shivangi Singh |
Jawaharlal Nehru Medical College |
Jawaharlal Nehru Medical College, BELAGAVI, KARNATAKA
Belgaum
KARNATAKA |
6360854775
singh.shivangi14997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of cholelithiasis admitted for laparoscopic cholecystectomy. Age Group: 18 to 65 years. |
|
| ExclusionCriteria |
| Details |
The patients with acute cholecystitis, empyema gall bladder, pancreatitis, obstructive jaundice and carcinoma of gall bladder will be excluded from study because in these cases it would be difficult to identify the anomalies due to obscured biliary anatomy. All pregnant females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Types and frequencies of variations and anomalies in biliary tree |
It will be assessed at the time of surgery, that is intraoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implications of variations & anomalies of biliary tree on Laparoscopic cholecystectomy. |
It will be assessed intraoperatively & up to 1 week post operatively. |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
31/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Variations in the anatomy
of gallbladder, bile ducts and
the arteries that supply them and liver are important
to the surgeon. because failure
to recognize them may lead to inadvertent ductal ligation, biliary
leaks and strictures after laparoscopic cholecystectomy. Congenital anomalies of extra hepatic biliary
tree have long been recognized but are
rare and may be of
clinical importance because they may provide surgeons with an unusual surprise during
laparoscopic cholecystectomy and may be of significance during laparoscopic surgery
as failure to recognize them leads to iatrogenic injuries
and can increase morbidity and mortality. |