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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.
 
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