| CTRI Number |
CTRI/2024/09/073571 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Inner preputial graft augmentation urethral repair in urethral stricture patients. |
|
Scientific Title of Study
|
Inner Preputial Graft substitution urethroplasty in urethral stricture patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Jani Ajaybhai Shivshankarbhai |
| Designation |
M.Ch. Urology Resident |
| Affiliation |
Gandhi medical college |
| Address |
Urology Department, 4th floor, Block 2, Hamidia Hospital, Sultania road, Royal market, Bhopal, Madhyapradesh.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9428412972 |
| Fax |
|
| Email |
jani.ajay222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Jain |
| Designation |
MBBS, MS, M.Ch. Urology |
| Affiliation |
Gandhi medical college |
| Address |
Urology Department, 4th floor, Block 2, Hamidia Hospital, Sultania road, Royal market, Bhopal, Madhyapradesh.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9971902853 |
| Fax |
|
| Email |
grabsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Jani Ajaybhai Shivshankarbhai |
| Designation |
M.Ch. Urology Resident |
| Affiliation |
Gandhi medical college |
| Address |
Urology Department, 4th floor, Block 2, Hamidia Hospital, Sultania road, Royal market, Bhopal, Madhyapradesh.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9428412972 |
| Fax |
|
| Email |
jani.ajay222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi medical college, Bhopal |
|
|
Primary Sponsor
|
| Name |
Gandhi medical college |
| Address |
Urology Department, 4th floor, Block 2, Hamidia Hospital, Sultania road, Royal market, Bhopal, Madhyapradesh. |
| 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 Jani Ajaybhai Shivshankarbhai |
Department of Urology, Gandhi medical college |
Urology Department, 4th floor, Block 2, Hamidia Hospital, Sultania road, Royal market, Bhopal, Madhyapradesh.
Bhopal
MADHYA PRADESH |
9428412972
jani.ajay222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
All male urethral stricture patient who will require substitution urethroplasty. |
|
| ExclusionCriteria |
| Details |
Patient with balanitis xerotica obliterans (BXO).
Patient with pan-urethral stricture.
Patient with active urinary tract infection (UTI).
Patient Not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short term(3 months) and Long term (6 months) success rate. |
Short term(3 months) and Long term (6 months) success rate. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess intra-operative and post-operative parameters. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
16/09/2024 |
| 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 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
|
Inner preputial graft substitution urethroplasty in urethral stricture patients this is the study that i will conduct in urethral stricture patients who require substitutional urethroplasty and patient will be followed for 6 months for assessment of outcome. |