| CTRI Number |
CTRI/2025/02/080555 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of sexual quality of life in young patients surviving with colorectal carcinoma.
|
|
Scientific Title of Study
|
To study sexual quality of life in young patient surviving with colorectal carcinoma.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Yashwant Raj Sakaray |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
Room number 6,Male Surgical Ward,Block C,5th floor,Nehru Hospital,PGIMER,Sector 12,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7569838589 |
| Fax |
|
| Email |
sakaraypgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yashwant Raj Sakaray |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
Room Number 6, Male Surgical Ward, Block C , 5th floor , Nehru Hospital , Pgimer ,Chandigarh
CHANDIGARH
160012
India |
| Phone |
7569838589 |
| Fax |
|
| Email |
sakaraypgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRANAB NEPAL FI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
BLOCK D , OLD DOCTORS HOSTEL,PGIMER, SECTOR 12 , CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08433504588 |
| Fax |
|
| Email |
drpranabnepal@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER , Sector-12,Chandigarh , Pin Code - 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER , Sector-12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
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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 Pranab Nepal Fi |
Post Graduate Institute Of Medical Science And Research |
Room number 6,Male Surgical Ward,Block C,5th floor,Nehru Hospital,PGIMER,Sector 12,Chandigarh
Chandigarh
CHANDIGARH |
8433504588
drpranabnepal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute Of Medical Science And Research,Chandigarh,Instutional Ethics Commitee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C182||Malignant neoplasm of ascending colon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Males and females between ages of 18 to 50. Diagnosed and treated for colorectal carcinoma at PGIMER, Chandigarh
- Surviving for morethan 3 months after completing intented treatment for colorectal cancer
- Sexually active
- Patients and their partner who are giving informed consent
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years or more than 50
- Patient or their partner who is not giving consent for research
- Patients who had previous history of sexual dysfunction before the disease.
- Patients having chronic illness affecting the sexual health.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Sexual Quality Of Life of young patients surviving with colorectal carcinoma. |
12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the sexual well-being of young patients surviving the colorectal carcinoma
2) To identify the challenges that influence their sexual quality of life.
|
12 weeks & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/02/2025 |
| 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
|
Patients fulfilling inclusion criteria. Has completed intented treatment for colorectal carcinoma at PGIMER.
Surviving for more than 3 months after treatment.
Subjects will be assessed at 3 months and at 6 months after the completion of treatment. Interview of participants using structured and semistructured questionnaire. Data entry, cleaning and coding will be done in Microsoft excel. SPSS version 26 and Microsoft excel will be used for descriptive and statistical analysis. Assessment of the outcome and its impact on SQOL. |