Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology (QoLMio)
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| ClinicalTrials.gov Identifier: NCT04635215 |
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Recruitment Status :
Completed
First Posted : November 19, 2020
Last Update Posted : July 28, 2021
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An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e. the creation of a stoma, has familiar, social and professional consequences. Personalized care, with the help of an ostomy nurse, is essential to accompany the ostomy patient in the changes of his or her life habits. In addition, the progress made in the various appliances, pouching and irrigation systems, contribute to improving the quality of life of these people.
In this context of adapted support, COLOPLAST has developed a range of ostomy pouches, the SenSura Mio BodyFit® technology range, for digestive or urinary stomas. The diversity of the devices makes it possible to find the most suitable combination to adapt to the morphology thanks to an elastic adhesive for a secure fit to individual body shape, and the textile materials used make it possible to optimize wearing comfort.
The aim of this study is to evaluate the quality of life of patients with recent ostomies with one of COLOPLAST's SenSura Mio devices at three months after discharge from the hospital. The condition of the skin around the stoma and the level of satisfaction of the patients will also be evaluated. Finally, the results obtained aim to identify factors predictive of a better quality of life in order to improve management.
| Condition or disease | Intervention/treatment |
|---|---|
| Ostomy | Device: Sensura Mio Bodyfit technology ostomy pouches |
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| Study Type : | Observational |
| Actual Enrollment : | 195 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of the Quality of Life of Patients With New Stoma Formation and Users of a Stoma Appliance From the SenSura Mio Range With Bodyfit® Technology |
| Actual Study Start Date : | February 27, 2019 |
| Actual Primary Completion Date : | March 31, 2021 |
| Actual Study Completion Date : | March 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Participants
There are not multiple groups in this study
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Device: Sensura Mio Bodyfit technology ostomy pouches
The use of medical devices, the ostomy pouches from Sensura Mio Bodyfit technology range, will be studied from inclusion visit (less than one month after the beginning of use) and during 3 months. |
- Stoma QoL score at 3 months [ Time Frame: The primary outcome will be measured at 3 months ]
The Stoma-QOL questionnaire has 20 questions covering 4 domains,: sleep, intimate relationships, relationships with family and close friends, and social relationships with other people.
For each question, the answer ranges from 1 (always) to 4 (never). The points obtained for each of the 20 questions are added together to obtain an overall score. This raw summary score per patient in the 20-80 range will be converted into a final "0-100 score" where 0 indicates the worst Quality of Life and 100 the best Quality of Life. A table is available for converting raw scores into final scores.
- Stoma QoL score at 1 and 2 months [ Time Frame: At 1 and 2 months ]
The Stoma-QOL questionnaire has 20 questions covering 4 domains,: sleep, intimate relationships, relationships with family and close friends, and social relationships with other people.
For each question, the answer ranges from 1 (always) to 4 (never). The points obtained for each of the 20 questions are added together to obtain an overall score. This raw summary score per patient in the 20-80 range will be converted into a final "0-100 score" where 0 indicates the worst Quality of Life and 100 the best Quality of Life. A table is available for converting raw scores into final scores.
- DET Score [ Time Frame: At 1, 2 and 3 months ]The DET Score is divided into three areas: Discoloration (D), Erosion (E) and Tissue Proliferation (T). For each area, a maximum of 5 points can be awarded, 3 for the affected area and 2 for severity. The scores for each domain should be based solely on observations of each subject's skin, not on past experience. Photographs of problem skin are included in this rating scale and can be used as a guide for scoring severity. Once the score for each domain has been assessed, a total score is calculated by adding the numbers. A score of 0 represents normal skin while a score of 15 represents maximum skin severity around the stoma.
- Patient satisfaction [ Time Frame: 3 months ]Patient satisfaction will be evaluated using a visual scale with a score comprised between 0 and 10. A score of 0 (lower value) means insatisfaction and a score of 10 (maximum) means total satisfaction.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- Male or female aged over 18 year old
- Subject who signed the consent form
- Subject affiliated to a social security scheme or entitled to a social security benefit
- Subject with an ostomy less than one month old, with an expected stoma duration > 3 months
- Subject presenting an enterostomy with liquid effluents (right colostomy, ileostomy, jejunostomy) or a urostomy, user of a high flow or drainable pouch (Uro)
- Subjects for which the healthcare professional decided to use the SenSura Mio Technology BodyFit™ as the first permanent ostomy appliance after surgery as part of the care routines
- Subject educated in ostomy care and who manages it himself in an autonomous or assisted manner.
Exclusion criteria
- Vulnerable subject with regard to the regulations in force
- Pregnant, parturient or breastfeeding woman ;
- Subject deprived of liberty by judicial, medical or administrative decision;
- Minor subject;
- Subject legally protected or unable to express consent;
- Subject not affiliated or not benefiting from a social security system;
- Subject falling into several of the above categories;
- Subject who refused to participate in the study; and
- Subject participating in other research or clinical studies
- Subject for which stoma closure is scheduled before the end of the study
- A subject who, according to the investigator, has cognitive problems that prevent him or her from answering a questionnaire or for whom evaluation could be problematic.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635215
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| Principal Investigator: | Guillaume Meurette, MD | CHU Nantes |
| Responsible Party: | Laboratoires Coloplast S.A.S |
| ClinicalTrials.gov Identifier: | NCT04635215 |
| Other Study ID Numbers: |
2018-A03232-53 2018-A03232-53 ( Other Identifier: ANSM (French competent authority ) |
| First Posted: | November 19, 2020 Key Record Dates |
| Last Update Posted: | July 28, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |