| CTRI Number |
CTRI/2024/03/063591 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life after hydrocele surgery |
|
Scientific Title of Study
|
To estimate the quality of life in patients of operated case of hydrocele |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JOSERAJ BELLA JOBEN SAMUEL |
| Designation |
Junior Resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of general surgery , Jawaharlal nehru medical college , Sawangi (meghe) ,Wardha, Pincode:442004, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
8778219710 |
| Fax |
|
| Email |
joesam1396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gharde |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of general surgery , Jawaharlal nehru medical college , sawangi (meghe), wardha , pincode: 442004, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
9372717775 |
| Fax |
|
| Email |
pankaj_nandini75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Gharde |
| Designation |
Professor |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of general surgery, Jawaharlal nehru medical college , sawangi (meghe), wardha , pincode:442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9372717775 |
| Fax |
|
| Email |
pankaj_nandini75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta meghe institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Joseraj Bella Joben Samuel |
| Address |
Room no 205, Laxmi boys hostel , Sawangi (meghe) , wardha , pincode:442004, Maharashtra |
| Type of Sponsor |
Other [self] |
|
|
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 Joben Samuel |
Acharya vinoba bhave rural hospital |
Department of general surgery , Jawaharlal nehru medical college , sawangi ( meghe) , wardha , Pincode:442004, Maharashtra
Wardha
MAHARASHTRA |
8778219710
joesam1396@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Quality of life after hydrocele surgery |
Frequency - 42
Total duration - 6 MONTHS |
| Intervention |
Quality of life after hydrocele surgery |
Frequency - 42
Total duration - 6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
PATIENTS WHO WERE ADMITTED AND HAD UNDERGONE HYDROCELE SURGERY AT OUR HOSPITAL
PATIENT READY TO GIVE CONSENT FOR TAKING PART IN THE STUDY |
|
| ExclusionCriteria |
| Details |
Patient less than 18 years of age ( pediatric hydrocele)
Comorbidities like uncontrolled diabetes, advanced liver disease, collagen disorders, psychological disorders
Patients with difficulty in understanding and replying,completing questionnaires |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE AFTER HYDROCELE SURGERY |
12-18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients will be interviewed on the basis of questionnaire containing 27 questions that will evaluate usual activities, self care, psychological well being & ability to do daily routine work |
12-18 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/03/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [joesam1396@gmail.com].
- For how long will this data be available start date provided 15-03-2024 and end date provided 15-03-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AFTER RECIEVING THE WRITTEN INFORMED CONSENT FROM STUDY PARTICIPANTS TO PARTICIPATE IN THE STUDY AND FOR PUBLICATION OF THEIR DATA.PATIENT WHO WERE ADMITTED AND UNDERGONE HYDROCELE SURGERY AT OUR HOSPITAL. TO ESTIMATE DISCOMFORT AFTER SURGERY OF HYDROCELE RESULTING FROM EACH ACTIVITY THROUGH A PRE STRUCTURED QUESTIONNAIRE.TO ESTIMATE THE SUMMATIVE PAIN SCORE.TO ESTIMATE THE CAPABILITY TO DO DAILY ROUTINE ACTIVITIES,SELF CARE, PSYCHOLOGICAL WELL BEING . TO ESTIMATE THE EVALUATION OF POST OPERATIVE SATISFACTION AS PER THE QUESTIONNAIRE |