| CTRI Number |
CTRI/2025/08/093002 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"A Survey amongst Stoma Patients in India Care Standards and Ostomy Appliance Usage" |
|
Scientific Title of Study
|
Understanding Factors Influencing Standards of Care and Usage
Patterns of Ostomy Appliances Amongst People Living with a Stoma in
India
-An Internal Survey
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Gupta |
| Designation |
Associate Manager Data Analyst |
| Affiliation |
INDEGENE LIMITED |
| Address |
INDEGENE LIMITED 3RD Floor Outer Ring Road, Aspen Block G4, Manyata Embassy Business Park Sez, Nagavara, Bangalore, Bangaluru Urban, Karnataka.
Bangalore KARNATAKA 560045 India |
| Phone |
9711730532 |
| Fax |
|
| Email |
neha.gupta@indegene.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rinky Mansukhani |
| Designation |
Clinical manager |
| Affiliation |
Coloplast India Pvt. Ltd., |
| Address |
Coloplast India Pvt. Ltd., IGL Complex, 4th Floor Tower 3, Plot No. 2B, Sector 126, Noida, UP, Delhi NCR, Pin 201304
India
Gautam Buddha Nagar UTTAR PRADESH 201304 India |
| Phone |
9311414380 |
| Fax |
|
| Email |
inrima@coloplast.com |
|
Details of Contact Person Public Query
|
| Name |
DrRinky Mansukhani |
| Designation |
Clinical manager |
| Affiliation |
Coloplast India Pvt. Ltd., |
| Address |
Coloplast India Pvt. Ltd.,
IGL Complex, 4th Floor
Tower 3, Plot No. 2B,
Sector 126, Noida, UP,
Delhi NCR, Pin 201304
India
Gautam Buddha Nagar UTTAR PRADESH 201304 India |
| Phone |
9311414380 |
| Fax |
|
| Email |
inrima@coloplast.com |
|
|
Source of Monetary or Material Support
|
| Coloplast India Pvt Ltd
IGL Complex 4th Floor
Tower 3 Plot No 2B
Sector 126 Noida UP
Delhi NCR Pin 201304
India |
|
|
Primary Sponsor
|
| Name |
Coloplast India Pvt Ltd |
| Address |
Coloplast India Pvt Ltd
IGL Complex 4th Floor
Tower 3 Plot No 2B
Sector 126 Noida UP
Delhi NCR Pin 201304
India |
| Type of Sponsor |
Other [ Medical Devices(Global)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Kumar |
All India Institute of Medical Sceinces, Bhubaneshwar |
Room no-G04, Department of General Surgery Ground floor, All India Institute of Medical Sciences, Sijua, Dumuduma, Bhubaneswar, Odisha 751019 Khordha ORISSA |
9711090814
drpkushwaha@gmail.com |
| Dr Satpal Singh Virk |
Dayanand Medical College and Hospital |
Ward no-305 ,Department of Gastrosurgery ,3rd floor, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001 Ludhiana PUNJAB |
9888016137
satpalsinghvirk@yahoo.com |
| Dr Gaurav Das |
Dr. Bhubaneswar Borooah Cancer Institute (BBCI) |
Room no-27, Department of Surgical Oncology ,Ground floor, Dr. Bhubaneshwar Borooah Cancer Institute ,A K Azad Road, Gopinath Nagar, Guwahati, Assam - 781016 Kamrup ASSAM |
8638149432
dr.gaurav@gmail.com |
| Dr Ankur Shrimal |
Radhe Govind Clinic |
D-5,Ground floor, krishna nagar 1st, gandhi nagar mode, Lalkothi, Jaipur, Rajasthan 302002 Jaipur RAJASTHAN |
8238017135
ankurshrimal0000@gmail.com |
| Dr Avanish Saklani |
Tata Memorial Hospital |
GI Colorectal Department Room No. 1212, 12th floor,Homi Bhabha Building Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 Mumbai MAHARASHTRA |
7400319886
asaklani@hotmail.com |
| Dr Dhaivat Vaishnav |
Zydus Hospitals |
Ground floor, Department of Surgical gastroenterology, Zydus Hospitals Road, Thaltej, S.G. Highway, Ahmedabad - 380054, Gujarat, India, Ahmadabad GUJARAT |
9825477683
dhaivat05@doctor.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| Drug Trial Ethics Committee Dayanand Medical College and Hospital |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics committee Dr. Bhubaneshwar Borooah Cancer Institute |
Approved |
| Institutional Ethics Committee-II Tata Memorial Hospital Tata Memorial Hospital |
Submittted/Under Review |
| Zydus Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K940||Colostomy complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 18 years
1 Temporary patients: Patients who have undergone stoma surgery within the
last 2 weeks at Visit 1 and have been advised that the stoma is temporary in
nature.
2 Permanent Patients: patients living with a stoma for 6 months and more. |
|
| ExclusionCriteria |
| Details |
1 Patients requiring a wheelchair or are bedridden leading to discomfort in managing
their stoma
2 Patients having a pre-existing diagnosed mental disorder
Permanent patients living with a stoma for less than 6 months
Patients who are unwilling to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study aims to identify factors influencing ostomy care standards and usage patterns of ostomy appliances in India. It will assess the impact of accessibility, insurance coverage, regional and healthcare setting differences, availability of counselling, climatic conditions, and affordability. The study also seeks to explore possible interventions to improve adoption and effective use of ostomy products.
|
9 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
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)
|
01/09/2025 |
| 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="0" Months="9" 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
|
A stoma is a surgically created opening that allows waste to leave the body and patients rely on special appliances such as ostomy bags for daily functioning The survey seeks to understand the factors that affect the quality of ostomy care and the patterns in which these appliances are used India’s healthcare system includes a wide mix of public hospitals private hospitals and nursing homes Due to this diversity the quality cost and accessibility of ostomy care can vary significantly Some patients receive detailed pre and post operative counselling and access to high quality products while others face gaps in care lack of information or affordability issues People living with a stoma often go through key phases including pre surgery counselling post surgery education and long-term management of complications at home When these steps are managed properly patients can experience improved quality of life However barriers such as unequal care between institutions limited insurance coverage and a lack of standardised education can lead to poor outcomes The objective of this survey is to gather insights from 600 stoma patients in India Both temporary and permanent stoma patients will be included Temporary patients will be surveyed twice once within 15 days of discharge and again within four to eight weeks of first visit Permanent patients will also have two visits at the start of the survey and again within three months of first visit The study will be conducted at both public and private hospitals Trained nurses will administer the surveys in person using printed forms and each form will be signed by both the nurse and the patient Participation will be voluntary and based on informed consent Adults aged 18 and above who have undergone colostomy ileostomy or urostomy surgery are eligible to participate Temporary stoma patients must have had surgery within the last two weeks while permanent patients must have been living with a stoma for at least six months Key outcomes expected from this survey include a better understanding of how patients use ostomy appliances how geographical and financial factors influence care and how much patients and caregivers know about ostomy management The study will also investigate insurance coverage availability of products and the role of education and counselling in improving patients quality of life Overall this survey will help identify major gaps in the current ostomy care system in India and provide valuable recommendations to improve patient support product accessibility and healthcare outcomes for those living with a stoma. |