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临床试验/CTRI/2025/08/093002
CTRI/2025/08/093002尚未招募不适用

Understanding Factors Influencing Standards of Care and Usage Patterns of Ostomy Appliances Amongst People Living with a Stoma in India -An Internal Survey

Coloplast India Pvt Ltd6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
600
试验地点
6
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: 9 months

次要结局

  • NA(NA)

研究者

发起方
Coloplast India Pvt Ltd
申办方类型
Other [ Medical Devices(Global)]
责任方
Principal Investigator
主要研究者

Neha Gupta

INDEGENE LIMITED

研究点 (6)

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