| CTRI Number |
CTRI/2024/04/066122 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Role of Fibro Scan in detecting transient liver changes in patients undergoing Laparoscopic surgery |
|
Scientific Title of Study
|
Preoperative FibroScan Grading of
Liver and Related Perioperative Morbidity during Laparoscopic Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona P |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
AIIMS Mangalagiri,Guntur district, ANDHRA PRADESH -522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9514729923 |
| Fax |
|
| Email |
sparatharaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mukesh Tripathi |
| Designation |
Head of the department, Department of Anaesthesiology, AIIMS Mangalagiri |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
Admin block, AIIMS Mangalagiri, Guntur district, ANDHRA PRADESH -522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8014910806 |
| Fax |
|
| Email |
drsamarjit@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sona P |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
AIIMS Mangalagiri, Guntur district, ANDHRA PRADESH -522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9514729923 |
| Fax |
|
| Email |
sparatharaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional support
AIIMS Mangalagiri |
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri Institution |
| Address |
AIIMS MG Campus,
Mangalagiri, Guntur District
Andhra Pradesh - 522503 |
| Type of Sponsor |
Research institution and 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 |
| Dr Sona P |
AIIMS Mangalagiri |
Department of Anesthesiology,AIIMS Mangalagiri Campus,
Mangalagiri, Guntur District
Andhra Pradesh - 522503
Guntur
ANDHRA PRADESH |
9514729923
sparatharaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,AIIMS MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Duration of surgery: at least >2 h
Patients with Clinical /Biochemical / Fibro scan diagnosed liver pathology
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients < 25 years of age and >65 years of age
3. ASA physical status 3 and 4
4. Pregnancy
5. Patients with advanced liver disease
6. Patient with confirmed diagnosis or active malignancy
7. Laparoscopic surgery converted to open surgery
8. Major hepatobiliary damage while operating |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fibro scan as preoperative tool to quantify non-alcoholic fatty liver disease in patients subjected to laparoscopic surgery.
2. To compare the effects of laparoscopic V/S non- laparoscopic abdominal surgery on liver function test in subclinical liver disease patients by FIBROSCAN
|
Preoperative(baseline), POD-0,POD-7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the correlation between Fibro scan with Liver Function Test & Color Doppler in assessing hepatic changes during laparoscopic surgery |
Preoperative baseline , POD -0 & POD-7 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/05/2024 |
| Date of Study Completion (India) |
01/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/07/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
FibroScan® is superior to ultrasound for the detection of liver scarring and therefore may be used to determine if cirrhosis or advanced fibrosis is present at the initial assessment and whether it has developed during follow up because of disease progression. In this study, we are trying to detect whether laparoscopy have deteriorating effect on liver function in patients with pre-existing hepatic disease and whether fibro scan can be a reliable tool for detecting acute changes in patients with preexisting hepatic disease and its correlation with liver function test and color doppler. There has been few studies on comparison between color doppler and fibro scan in patients with cirrhosis and non-alcoholic steatohepatitis(NASH) .To best of our knowledge , this study has not been conducted in Indian population |