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Colostomy Stoma clinical trials

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NCT ID: NCT06394115 Completed - Ileostomy - Stoma Clinical Trials

Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study

OUTFLOW
Start date: August 1, 2022
Phase:
Study type: Observational

The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.

NCT ID: NCT05635188 Completed - Clinical trials for Surgical Procedure, Unspecified

Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection

Start date: January 2008
Phase:
Study type: Observational

This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).

NCT ID: NCT05466721 Completed - Colostomy Stoma Clinical Trials

Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

Start date: June 13, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05289765 Completed - Ileostomy - Stoma Clinical Trials

Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene

gAOVEstoma
Start date: February 22, 2022
Phase: N/A
Study type: Interventional

To evaluate the efficacy of the application of a neutral gel based on ecological extra virgin olive oil for peristomal skin hygiene in individuals with colostomy and ileostomy.

NCT ID: NCT05200416 Completed - Ileostomy - Stoma Clinical Trials

Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status. The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

NCT ID: NCT05163873 Completed - Quality of Life Clinical Trials

ExPECT: Extraperitoneal End Colostomy Trial

ExPECT
Start date: December 9, 2021
Phase: N/A
Study type: Interventional

A randomised controlled feasibility study to compare two surgery techniques in the formation of a permanent end colostomy; the trans-peritoneal(TP) technique - currently, the most commonly used technique and the investigational extra-peritoneal(EP) technique, which has been reported in small studies to reduce the risk of parastomal hernia . This feasibility study will primarily aim to determine the feasibility viability of progression to a full multi-centre trial and test study design acceptability for participants. Participants will be asked to consent to be randomised to either the TP or EP procedure during surgery. Following surgery, participants will be followed up to a maximum of 12 months and asked to complete quality of life questionnaires (EQ5D and Colostomy Impact Score). Participant data will also be accessed by research teams at site to collect data on stoma appliance use and complications.

NCT ID: NCT04793009 Completed - Hernia Clinical Trials

Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection

Start date: January 1, 2013
Phase:
Study type: Observational

This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.

NCT ID: NCT04141566 Completed - Quality of Life Clinical Trials

Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma

Start date: January 1, 2018
Phase:
Study type: Observational

Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an abdominoperineal resection (APR) for ultra low rectal cancer

NCT ID: NCT03770078 Completed - Ileostomy - Stoma Clinical Trials

Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

Start date: November 12, 2018
Phase: N/A
Study type: Interventional

The study investigates the performance of a new adhesive with regard to the skin condition

NCT ID: NCT03108105 Completed - Colostomy Stoma Clinical Trials

Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.