Clinical trial NCT04635215: Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ostomy
Lead sponsor: Laboratoires Coloplast S.A.S
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Today, there are about 80,000 people with ostomies in France and 19,000 ostomies are created each year.

An ostomy is defined by a viscera reaching the skin, outside its natural location, by diversion of the digestive (enterostomy) or urinary (ureterostomy) tract. Digestive ostomies are temporary or permanent palliative surgeries that consist of connecting a segment of the healthy digestive tract to the surface of the skin, either downstream or upstream of a lesion. There are several reasons for this type of stoma: following colorectal cancer or IBD (chronic inflammatory bowel disease), or to decompress and drain the digestive tract in occlusion, or to protect a digestive anastomosis by temporarily diverting the intestinal flow. Urinary ostomies are usually performed following bladder cancer or neurogenic bladder that has resulted in the removal of the bladderr. The urinary tract is then diverted to allow the evacuation of urine into an artificial pouch.

The bodily injury, the creation of a stoma, can have serious familiar, social and professional repercussions. An early follow-up from the preoperative phase and long-term technical and psychological support promote an adaptation of quality. Helping the patient to live well with his disability is a complex task that mobilizes the skills of a multidisciplinary team of caregivers. Mastery of surgical techniques for the creation of ostomies and close collaboration between the surgeon and the stoma therapist are essential for the personalized care of ostomy patients.

Advances in various devices, bag systems and irrigation systems are concrete means that contribute greatly to improving the patient's quality of life. In this context of technological advances, COLOPLAST has developed a range of devices for incontinent digestive and urinary stomas, SenSura Mio Technology BodyFit®. This range of pouches adapts to peristomal morphology and body movements due to an elastic adhesive for a secure fit to individual body shapes. In addition, the pouches are designed to remain discreet and maximize wearing comfort due to a neutral-grey color water-repellent textile material, invisible even under white clothing, and a full-circle prefilter to differ filter saturation for proven reduction of ballooning.

The objective of this study is to evaluate the use of SenSura Mio products in real-life conditions in patients with recent ostomies. For this purpose, we will use the Stoma-QoL specific quality of life scale, as well as the Peristomal Skin Condition Rating Scale (DET Score).

The Stoma-QoL tool was developed and validated specifically for ostomy patients in 2005 at the initiative of COLOPLAST and in close collaboration with international experts, with the aim of evaluating the impact of ostomy related concerns on the quality of life of ostomy patients on the one hand, and improving and facilitating their follow-up on the other hand. Potential items were formulated based on the results of a series of semi-structured interviews conducted with 169 adult subjects who had ostomies for a long time. The process resulted in a preliminary version of 37 items, administered repeatedly to 182 subjects with an ileostomy or colostomy. A psychometric selection of the items was performed using a Rasch model. The Stoma-QOL questionnaire has in its most refined version 20 questions covering 4 domains, not scored independently: sleep, intimate relationships, relationships with family and close friends, and social relationships with other people. This 20-item version has been validated internationally in ileo- or colostomized patients. On average, the value of the overall Stoma-QoL score was 58.5 with the lowest mean value (53.8) observed in France and the highest mean value (62.6) in Denmark. Stoma-QoL can be offered to ostomy patients who have already lived at least 1 month with their stoma and appliance.

The DET Score -also known as the Ostomy Skin Tool- is a measurement tool for assessing the extent and severity of peristomal skin problems. It was developed by Martins et al in 2008, at the initiative of COLOPLAST and in close collaboration with international experts, with the intention of improving the monitoring of peristomal skin conditions in ostomy patients and optimizing communication between healthcare professionals. 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. The DET Score was validated in 2011 18: it is now widely used and has been translated into several languages. Skin problems are considered mild if DET Score ≤ 4; moderate if DET Score \< 7; severe if DET Score ≥ 7. The mean value observed in an international study of more than 3,000 ostomy patients was 2.5 (± 2.8).

The objectives of the present study are multiple: to evaluate the quality of life of patients with recent ostomies using SenSura Mio appliances during the first three months following hospital discharge, to evaluate the condition of the peristomal skin during this same period and to look for factors predictive of a better quality of life. The data collected in this study will help to better document the factors influencing the quality of life of French patients with recent ostomies and the value of using the new SenSura Mio appliances. This study will also provide a better understanding of the incidence of skin problems in the early follow-up phase (first three months) and the main corrective actions taken by the ostomy nurses.

The QoL Mio study population will be composed of adults with recent ostomies (stoma preparation \< 1 month), with liquid effluent (right colostomy, ileostomy, jejunostomy or urostomy), for whom healthcare professionals have recommended the use of SenSura Mio devices for ostomy care as part of the routine care. Because liquid effluents can seep under the adhesive on the skin, this population (ostomy with liquid effluents) has a higher risk of peristomal skin damage with irritant dermatitis by contact with corrosive effluents. The BodyFit technology (conforms to folds and irregularities of the skin) of SenSura Mio devices appears to be particularly suitable in this population to preserve the integrity of the peristomal skin.

Eligibility criteria: 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.

Primary outcomes:
measure: Stoma QoL score at 3 months
timeFrame: The primary outcome will be measured at 3 months
Secondary outcomes:
measure: Stoma QoL score at 1 and 2 months
timeFrame: At 1 and 2 months
measure: DET Score
timeFrame: At 1, 2 and 3 months
measure: Patient satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier Du Pays D'Aix
city: Angers
country: France
facility: Hotel Dieu
city: Arras
country: France
facility: Centre Hospitalier d'Arras
city: Ars-Laquenexy
country: France
facility: Hopital de Mercy
city: Aurillac
country: France
facility: Centre Hospitalier Henri Mondor
city: Avignon
country: France
facility: Ch Henri Duffaut
city: Bayonne
country: France
facility: Clinique Belharra
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Besançon
country: France
facility: Hopital Jean Minjoz
city: Brest
country: France
facility: Hopital La Cavale Blanche
city: Caen
country: France
facility: Hopital Cote de Nacre
city: Cambrai
country: France
facility: Centre Hospitalier de Douai
city: Castres
country: France
facility: Hopital Du Pays D Autan
city: Charleville-Mézières
country: France
facility: Hopital Manchester
city: Cherbourg Octeville
country: France
facility: Centre Hospitalier Du Cotentin Site de Cherbourg
city: Châteauroux
country: France
facility: Centre Hospitalier General
city: Clichy
country: France
facility: Hopital Beaujon
city: Corbeil-Essonnes
country: France
facility: Hopital Sud Francilien
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Ermont
country: France
facility: Clinique Claude Bernard
city: Flins-sur-Seine
country: France
facility: Cabinet Infirmier
city: Gleizé
country: France
facility: Hopital Nord Ouest
city: Gonesse
country: France
facility: Centre Hospitalier de Gonesse
city: La Rochelle
country: France
facility: Hopital Saint Louis
city: La Source
country: France
facility: Hopital La Source
city: Le Havre
country: France
facility: Hopital Prive de L Estuaire
city: Le Mans
country: France
facility: Pole Sante Sud
city: Lens
country: France
facility: Centre Hospitalier Du Dr Schaffner
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Limoges
country: France
facility: Hopital Dupuytren
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Marseille
country: France
facility: Hopital Nord
city: Marseille
country: France
facility: Hopital Alphonse Laverand
city: Marseille
country: France
facility: Hopital de La Conception
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois Site Annecy
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Mâcon
country: France
facility: Polyclinique Du Val de Saone
city: Nantes
country: France
facility: Clinique St Augustin
city: Nantes
country: France
facility: CHU Hôtel-Dieu
city: Niort
country: France
facility: Centre Hospitalier Georges Renon
city: Nîmes
country: France
facility: Hopital Caremeau
city: Pabu
country: France
facility: Centre Hospitalier de Guingamp
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Tenon
city: Pau
country: France
facility: Centre Hospitalier Francois Mitterand
city: Perpignan
country: France
facility: Hopital Saint Jean
city: Pessac
country: France
facility: Clinique Mutualiste de Pessac
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire La Miletrie
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Rochefort
country: France
facility: Centre Hospitalier de Rochefort
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Saint-Brieuc
country: France
facility: Hopital Yves Le Foll
city: Saint-Dié-des-Vosges
country: France
facility: Centre Hospitalier St Charles
city: Saint-Hilaire-de-Riez
country: France
facility: Cabinet infirmier
city: Saint-Priest-en-Jarez
country: France
facility: Hopital Nord
city: Sallanches
country: France
facility: Les Hopitaux Du Mont Blanc
city: Salon-de-Provence
country: France
facility: Centre Hospitalier de Salon de Provence
city: Seclin
country: France
facility: Centre Hospitalier de Seclin/Carvin
city: Strasbourg
country: France
facility: Hopital Civil
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Tarbes
country: France
facility: Centre Hospitalier de La Gespe
city: Thonon-les-Bains
country: France
facility: Hopitaux Du Leman Site Thonon
city: Toulon
country: France
facility: Hopital Sainte Musse
city: Toulouse
country: France
facility: Hopital Rangueil
city: Troyes
country: France
facility: Hopital Des Hauts Clos
city: Valence
country: France
facility: Centre Hospitalier General
city: Valenciennes
country: France
facility: Polyclinique Vauban
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
city: Vandœuvre-lès-Nancy
country: France
facility: Hopitaux de Brabois
city: Vantoux
country: France
facility: Hopital Robert Schuman
city: Étrelles
country: France
facility: Cabinet infirmier
city: Évreux
country: France
facility: Centre Hospitalier Intercommunal Eure Seine
Study officials:
affiliation: Nantes University Hospital
name: Guillaume Meurette, MD
role: PRINCIPAL_INVESTIGATOR
References: