Clinical trial NCT05466721: Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
Official title: HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy Stoma
Lead sponsor: Hydrumedical
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.

The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.


Eligibility criteria: Inclusion Criteria:

* Written informed consent;
* Male and Female patients;
* Adult aged ≥ 18;
* Descending and sigmoid colostomy created more than 3 months previously to the beginning of the study;
* Having formed stool and using a flat ostomy appliance;
* Able to understand the study procedures and fill questionaries;
* Able to apply and remove the ostomy device autonomously.

Exclusion Criteria:

* Repeated experiences of leakage with the usual ostomy device,
* Chronically liquid stools,
* Peristomal skin disorders,
* Known allergic reactions to components of the device,
* Receiving chemotherapy, radiation therapy or steroids in the previous month

Primary outcomes:
measure: Efficacy of the device (journal of capsule/bag changes)
timeFrame: 14 days
measure: Quality of life of the participant (Stoma Quality of Life questionnaire)
timeFrame: 14 days
measure: Adverse effects
timeFrame: 14 days
measure: Safety of the device (Discolouration, Erosion, Tissue overgrowth score)
timeFrame: 14 days
Secondary outcomes:
measure: Satisfaction of the participant (questionnaire)
timeFrame: 14 days
Other outcomes:
Locations:
city: Guimarães
country: Portugal
facility: Hospital Da Senhora Da Oliveira - Guimarães
state: Braga
city: Braga
country: Portugal
facility: Hospital de Braga
city: Penafiel
country: Portugal
facility: Centro Hospitalar do Tâmega e Sousa
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás-os-Montes e Alto Douro
Study officials:
affiliation: Hospital de Braga
name: Palmira Peixoto
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Da Senhora Da Oliveira - Guimarães
name: Paula Costa
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
name: Liliana Miranda
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar de Entre o Douro e Vouga
name: Sara Costa
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Glória Gonçalves
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar do Tâmega e Sousa
name: Carla Nunes
role: PRINCIPAL_INVESTIGATOR
References: