| CTRI Number |
CTRI/2024/12/077969 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patient Life After undergoing Penile Cancer Surgery |
|
Scientific Title of Study
|
Quality of life after penile cancer 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 |
Dr Siddalingeshwara Chandragowda Doddamani |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room No 14, Urology OPD, Department of Urology and Renal Transplant, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India – 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9037694261 |
| Fax |
|
| Email |
sidcd01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddalingeshwara Chandragowda Doddamani |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room No 14, Urology OPD, Department of Urology and Renal Transplant, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India – 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9037694261 |
| Fax |
|
| Email |
sidcd01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddalingeshwara Chandragowda Doddamani |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room No 14, Urology OPD, Department of Urology and Renal Transplant, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India – 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9037694261 |
| Fax |
|
| Email |
sidcd01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
KMC, Manipal |
| Address |
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
| 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 Siddalingeshwara CD |
Kasturba Hospital |
Room 14, Urology OPD, Department of Urology, Kasturba Medical college, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, 576104
Udupi
KARNATAKA |
9037694261
sidcd01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N488||Other specified disorders of penis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
All patients who underwent surgical treatment of penile cancer in the last 5 years |
|
| ExclusionCriteria |
| Details |
distant metastasis, recurrent penile cancer, second primary tumour and if not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related Quality of Life |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sexual Quality of Life |
1 year |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/01/2025 |
| 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 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
|
Penile cancer surgery,
often described as mutilating, profoundly impacts patients’ well-being, psycho-socio health, and social
relationships. By analyzing patient records and utilizing standardized assessments, the study seeks to
provide insights into the post treatment quality of life and sexual function. This can help in preoperative
counselling, informed decision making and tailoring surgical approaches to optimize outcomes for
individuals undergoing penile cancer surgery.
|