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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04635215
Other study ID # 2018-A03232-53
Secondary ID 2018-A03232-53
Status Completed
Phase
First received
Last updated
Start date February 27, 2019
Est. completion date March 31, 2021

Study information

Verified date July 2021
Source Laboratoires Coloplast S.A.S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Laboratoires Coloplast S.A.S

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Stoma QoL score 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.
At 1 and 2 months
Secondary DET Score 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. At 1, 2 and 3 months
Secondary Patient satisfaction 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. 3 months
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