Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
QoLMio
1 other identifier
observational
195
1 country
78
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
Typical duration for all trials
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2019
CompletedFirst Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedJuly 28, 2021
July 1, 2021
2.1 years
November 13, 2020
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Stoma QoL score 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.
The primary outcome will be measured at 3 months
Secondary Outcomes (3)
Stoma QoL score at 1 and 2 months
At 1 and 2 months
DET Score
At 1, 2 and 3 months
Patient satisfaction
3 months
Study Arms (1)
Participants
There are not multiple groups in this study
Interventions
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.
Eligibility Criteria
The QoL Mio study population will consist of adults with recent ostomies (\< 1 month after stoma creation) for whom healthcare professionals have recommended the use of SenSura Mio ostomy care devices as part of care routines.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Centre Hospitalier Du Pays D'Aix
Aix-en-Provence, 13616, France
Hotel Dieu
Angers, 49933, France
Centre Hospitalier d'Arras
Arras, 62022, France
Hopital de Mercy
Ars-Laquenexy, 57530, France
Centre Hospitalier Henri Mondor
Aurillac, 15002, France
Ch Henri Duffaut
Avignon, 84902, France
Clinique Belharra
Bayonne, 64100, France
Centre Hospitalier de Beauvais
Beauvais, 60021, France
Hopital Jean Minjoz
Besançon, 25030, France
Hopital La Cavale Blanche
Brest, 29609, France
Hopital Cote de Nacre
Caen, 14033, France
Centre Hospitalier de Douai
Cambrai, 59187, France
Hopital Du Pays D Autan
Castres, 81108, France
Hopital Manchester
Charleville-Mézières, 8011, France
Centre Hospitalier General
Châteauroux, 36019, France
Centre Hospitalier Du Cotentin Site de Cherbourg
Cherbourg Octeville, 50102, France
Hopital Beaujon
Clichy, 92118, France
Hopital Sud Francilien
Corbeil-Essonnes, 91106, France
Centre Georges François Leclerc
Dijon, 21079, France
Clinique Claude Bernard
Ermont, 95120, France
Cabinet infirmier
Étrelles, 35370, France
Centre Hospitalier Intercommunal Eure Seine
Évreux, 27015, France
Cabinet Infirmier
Flins-sur-Seine, 78410, France
Hopital Nord Ouest
Gleizé, 69400, France
Centre Hospitalier de Gonesse
Gonesse, 95500, France
Hopital Saint Louis
La Rochelle, 17000, France
Hopital La Source
La Source, 45100, France
Hopital Prive de L Estuaire
Le Havre, 76620, France
Pole Sante Sud
Le Mans, 72016, France
Centre Hospitalier Du Dr Schaffner
Lens, 62307, France
Hopital Robert Boulin
Libourne, 33505, France
Hopital Dupuytren
Limoges, 87042, France
Hopital Saint Philibert
Lomme, 59160, France
Hopital Nord
Marseille, 13015, France
Hopital Alphonse Laverand
Marseille, 13384, France
Hopital de La Conception
Marseille, 13385, France
Polyclinique Du Val de Saone
Mâcon, 71031, France
Centre Hospitalier Annecy Genevois Site Annecy
Metz-Tessy, 74370, France
Hopital Lapeyronie
Montpellier, 34295, France
Clinique St Augustin
Nantes, 44046, France
CHU Hôtel-Dieu
Nantes, 44093, France
Centre Hospitalier Georges Renon
Niort, 79021, France
Hopital Caremeau
Nîmes, 30029, France
Centre Hospitalier de Guingamp
Pabu, 22200, France
Hopital Saint Louis
Paris, 75475, France
Hopital Saint Antoine
Paris, 75572, France
Hopital Saint Antoine
Paris, 75573, France
Hopital Cochin
Paris, 75679, France
Hopital Bichat Claude Bernard
Paris, 75877, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Hopital Tenon
Paris, 75970, France
Centre Hospitalier Francois Mitterand
Pau, 64000, France
Hopital Saint Jean
Perpignan, 66046, France
Clinique Mutualiste de Pessac
Pessac, 33605, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire La Miletrie
Poitiers, 86021, France
Hopital Pontchaillou
Rennes, 35033, France
Centre Hospitalier de Rochefort
Rochefort, 17301, France
Hopital Charles Nicolle
Rouen, 76031, France
Hopital Yves Le Foll
Saint-Brieuc, 22027, France
Centre Hospitalier St Charles
Saint-Dié, 88187, France
Cabinet infirmier
Saint-Hilaire-de-Riez, 85270, France
Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Les Hopitaux Du Mont Blanc
Sallanches, 74703, France
Centre Hospitalier de Salon de Provence
Salon-de-Provence, 13658, France
Centre Hospitalier de Seclin/Carvin
Seclin, 59471, France
Hopital Civil
Strasbourg, 67091, France
Hopital Hautepierre
Strasbourg, 67098, France
Centre Hospitalier de La Gespe
Tarbes, 65013, France
Hopitaux Du Leman Site Thonon
Thonon-les-Bains, 74203, France
Hopital Sainte Musse
Toulon, 83056, France
Hopital Rangueil
Toulouse, 31059, France
Hopital Des Hauts Clos
Troyes, 10003, France
Centre Hospitalier General
Valence, 26953, France
Polyclinique Vauban
Valenciennes, 59300, France
Centre Hospitalier de Valenciennes
Valenciennes, 59322, France
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Hopital Robert Schuman
Vantoux, 57070, France
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume Meurette, MD
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 19, 2020
Study Start
February 27, 2019
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share