| CTRI Number |
CTRI/2024/03/063654 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
What are the risk factors of Pus in liver in common populations |
|
Scientific Title of Study
|
Analysis of risk factors of patients presented with liver abscess |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Kumar patel |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh University of medical sciences Saifai etawahSaifai Etawah |
| Address |
Dept of General surgery ROOM No202 DTH JR Hostel UPUMS Saifai etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8576947173 |
| Fax |
|
| Email |
vikasbmw002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Gupta |
| Designation |
Senior resident |
| Affiliation |
Uttar Pradesh University of Medical sciences Saifai etawah Saifai Etawah |
| Address |
Dept of general surgery ROOM No 205 PRA Hostel UPUMS Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7017165050 |
| Fax |
|
| Email |
vinyboss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Gupta |
| Designation |
Senior resident |
| Affiliation |
Uttar Pradesh University of Medical sciences Saifai etawah Saifai Etawah |
| Address |
Dept of general surgery ROOM No 205 PRA Hostel UPUMS Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7017165050 |
| Fax |
|
| Email |
vinyboss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah, UP |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Uttar Pradesh University of Medical Sciences, Saifai , etawah, UP |
| Type of Sponsor |
Government medical college |
|
|
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 Vikas Kumar patel |
Uttar Pradesh University of Medical Sciences |
Department of general surgery,Uttar Pradesh University of medical sciences Saifai, Etawah UP
Old building Room no 61/62
Etawah
UTTAR PRADESH |
8576947173
vikasbmw002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttar Pradesh University of Medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K750||Abscess of liver, (2) ICD-10 Condition: K750||Abscess of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Nil |
| Comparator Agent |
Group B |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient admitted and diagnosed clinically and radiologically of liver abscess |
|
| ExclusionCriteria |
| Details |
Hepatic cyst
Hydatid cyst
Malignancy
Liver mets |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mortality
30 days re-admission
Intensive care utilization
|
4 weeks and 9 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hospital stay
Return to normal work |
4 weeks & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
14/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Retrospective single arm study to be held in UPUMS saifai etawah for patients of liver abscess to assessment of various risk factors We have planned this study over 150 patients with inclusion and exclusion criteria as mentioned earlier. Ethical clearance has been obtained to do study |