Clinical trials: Ostomy
Stoma Ileostomy, Stoma Colostomy
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- Trial name
- StomaCare (NCT05076669)
- Testing
- stoma follow-up, standard of care
- Where
- 10 sites in France
- Volunteers
- 350 people
- Sponsor
- FSK
Educational Problems, Colostomy Complications
Educational Program for Ostomy Patients (Ostomeducat)
Stoma surgery is a relatively common treatment for patients suffering from colorectal diseases.This study aimed to investigate the impact on hospital stay and short-term overall complications prior to and following the…
- Conditions
- Educational Problems, Colostomy Complications, Surgery, Colorectal Disorders
- Trial name
- ostomeducat (NCT03995719)
- Testing
- Preoperative education, Postoperative education
- Where
- Spain
- Volunteers
- 138 people
- Sponsor
- Mª Victoria Maestre Sanchez
Ostomy
Different Levels of Patient Education for Care of Ostomy Site
This is a randomized study of standard versus extra ostomy education.
- Trial name
- NCT02036268
- Testing
- Standard, Pre-operative Education, Two-week Post Operative Education
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Indiana University
Ileostomy - Stoma, Colostomy Stoma
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
The study investigates the performance of a new adhesive with regard to the skin condition
- Trial name
- NCT03770078
- Testing
- Test Product A
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 23 people
- Sponsor
- Coloplast A/S
Surgical Site Infection, Wound Surgical
Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are: 1. Surgical site infection rates 2. Patient quality of life 3.
- Conditions
- Surgical Site Infection, Wound Surgical, Colorectal Disorders
- Trial name
- NCT06309368
- Testing
- Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation, Pursestring Closure
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Nevada, Las Vegas
Ostomy
Observational Evaluation of the Peristomal Skin Condition in Ostomates
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.
- Trial name
- OSMOSE (NCT01526967)
- Where
- 13 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- ConvaTec Inc.
Ostomy
Evaluation of an Ostomy Leakage Detection System
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
- Trial name
- NCT06547905
- Testing
- Ostomy Leakage Detection System
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- Hollister Incorporated
Colostomy Stoma
Ostomy Telehealth For Cancer Survivors
The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to…
- Trial name
- PCORI (NCT02974634)
- Testing
- Ostomy self management training
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- University of Pennsylvania
Simulation-based Learning, Nursing Students
High-fidelity Simulators and Standardized Patients on the Stoma Care
This is a randomized controlled study to investigate the effects of skill training on a low-fidelity simulator with a standardized patient using a wearable ostomy model on the stoma care skills and satisfaction levels of nursing…
- Conditions
- Simulation-based Learning, Nursing Students, Ostomy
- Trial name
- NCT06826404
- Testing
- Training provided with a wearable ostomy model and standardized patient, Training low fidelity simulator
- Where
- Turkey (Türkiye)
- Volunteers
- 102 people
- Sponsor
- Aydin Adnan Menderes University
Ostomy
Comparison Study of 3 Ostomy Products
To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.
- Trial name
- NCT01691729
- Testing
- Ostomy accessory
- Where
- 4 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- ConvaTec Inc.
Stoma Site Leakage
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
- Trial name
- NCT04544566
- Testing
- Test product A, Test product B, Comparator
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma, Colostomy Stoma
A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative…
- Trial name
- NCT03707392
- Testing
- Ostomy Education Video, Control - Standard ostomy education
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Ostomy
Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
The purpose of this research is to assess the impact of a telephone follow-up visit on rehospitalizations after ostomy surgery.
- Trial name
- NCT07879872
- Testing
- Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Mayo Clinic
Stoma Ileostomy
Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively.
- Trial name
- NCT07316530
- Testing
- CP381
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Coloplast A/S
Ileostomy
An Investigation of Ostomy Devices
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.
- Trial name
- NCT01514136
- Testing
- Ostomy appliance: convex 1-piece drainable
- Where
- Denmark
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S
Colorectal Cancer (CRC), Stoma
Mindfulness and Self-Compassion Intervention for Ostomy Patients Due to Colorectal Cancer on Loneliness (MSC-OP)
Loneliness is a profound health risk for colorectal cancer (CRC) survivors, particularly those with stomas who face significant stigma and social anxiety.
- Trial name
- MSC-OP (NCT07809074)
- Testing
- The MSC-OP group, usual care
- Volunteers
- 20 people
- Sponsor
- The Hong Kong Polytechnic University
Ostomy - Ileostomy or Colostomy
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
The goal of this clinical trial is to evaluate the effect of planned group interaction on ostomy adaptation, quality of life, and stoma care self-efficacy in adult individuals (aged 18 and older) living with a stoma.
- Trial name
- stoma-group (NCT07894757)
- Testing
- Planned Group Interaction Program
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Gazi University
Ileostomy - Stoma, Colostomy Stoma
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT05200416
- Testing
- Heylo, Standard of Care
- Where
- Germany
- Volunteers
- 144 people
- Sponsor
- Coloplast A/S
Ostomy - Ileostomy or Colostomy
Improving Outcomes of Older Adults Undergoing Ostomy Surgery
The goal of this pilot study is to learn if an intervention in patients undergoing ostomy surgery is easy to use. The overall goal of the work is to improve quality of life during recovery in the days after surgery for these…
- Trial name
- NCT07424586
- Testing
- Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Ileostomy - Stoma
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
- Trial name
- NCT01957488
- Testing
- Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 183 people
- Sponsor
- Coloplast A/S