Clinical trials: Ostomy
Ileostomy, Colostomy
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
- Trial name
- NCT02362360
- Testing
- Coloplast Test Product, Comparator (Hollister)
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 52 people
- Sponsor
- Coloplast A/S
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
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
Complication,Postoperative, Stoma
Chinese Ostomy Collaboration Group (COCG) Clinical Study -SITI Classification
Colorectal cancer is an important cancer worldwide, and its incidence is increasing year by year. A large proportion of patients may require diverting stoma or even permanent stoma after surgery.
- Trial name
- COCG-SITI (NCT07111429)
- Testing
- Novel severity grading system of stoma-related complication in cancer patients
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- Peking University Cancer Hospital & Institute
Ileostomy - Stoma, Ileostomy; Complications
Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system.
- Trial name
- NCT03982875
- Testing
- Alfred SmartBag
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- 11 Heath and Technologies Limited
Leakage, Skin Condition
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
Introduction: It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.
- Trial name
- NCT01448629
- Testing
- Standard Care, River
- Sponsor
- Coloplast A/S
Ostomy, Sleep Quality
Artificial Intelligence-Supported Nursing Program for Sleep Quality in People With an Ostomy
Individuals living with an intestinal or urinary stoma frequently report disturbed sleep. Night-time pouch filling and leakage, odour and gas concerns, restricted sleeping positions, peristomal skin problems and the need for…
- Conditions
- Ostomy, Sleep Quality, Quality of Life
- Trial name
- AI-MNI (NCT07805226)
- Testing
- AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people
- Sponsor
- Koç University
Ileostomy - Stoma
Investigation of the Performance of Ostomy Base Plate
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2.
- Trial name
- NCT01103466
- Testing
- Atlas, SenSura, Conform 2
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Nurse's Role, Patient Compliance
The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Lesions
To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma.
- Conditions
- Nurse's Role, Patient Compliance, Peristomal Skin Complication, Self Efficacy
- Trial name
- NCT05664503
- Testing
- Assigned Interventions STOMA-M
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Istanbul University
Ostomy
Study on the Stoma Appliance Flexima®/Softima® 3S
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's…
- Trial name
- KISSS (NCT03133585)
- Testing
- 2 piece appliance for stomy
- Where
- 2 sites in France
- Volunteers
- 1,500 people
- Sponsor
- BBraun Medical SAS
Anesthesia, Ostomy
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
- Trial name
- NCT01136668
- Testing
- Transversus Abdominis Plane Block, Standard
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- The Hospital for Sick Children
Stoma Care Education in Nursing Students, Gamification
Gamification in Stoma Care Education for Nursing Students
his study aims to determine the effect of a gamification-based educational method on nursing students' learning of stoma care. The research will be conducted as a pretest-posttest, parallel-group randomized controlled…
- Conditions
- Stoma Care Education in Nursing Students, Gamification, Nursing Education, Ostomy - Ileostomy or Colostomy
- Trial name
- GAME-STOMA (NCT07500857)
- Testing
- Gamification-Based Stoma Care Education, Traditional Education
- Volunteers
- 72 people
- Sponsor
- Gazi University
Stoma Ileostomy
Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient
The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.
- Trial name
- StomABC (NCT03462667)
- Testing
- Stoma Boot Camp, Standard of Care
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Kansas Medical Center
Ostomy, Ileal Conduit
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education.
- Trial name
- NCT06583577
- Testing
- 3D Ostomy simulator
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Minnesota
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
Stoma Colostomy, Stoma Ileostomy
Management Of Stoma In Patients Younger Than 3 Months Old
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also…
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Neonatal Disease
- Trial name
- STOMP (NCT06458699)
- Where
- France
- Volunteers
- 82 people
- Sponsor
- University Hospital, Clermont-Ferrand
Body Image Disorder
Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
This is a non-blinded, randomized, controlled clinical trial consisting of 64 participants, which aims to assess the effectiveness of a nursing intervention for family members and patients prior to surgery to prevent body image…
- Trial name
- NCT03726801
- Testing
- HEALTH EDUCATION
- Where
- Spain
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Universidad Complutense de Madrid
Ostomy
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.
- Trial name
- NCT02472639
- Testing
- Ostom-i Alert Sensor, No Ostom-i Alert Sensor
- Volunteers
- 7 people
- Sponsor
- Cedars-Sinai Medical Center
Inflammatory Bowel Diseases, Anorectal Malformations
StoMakker Mobile Application
The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent…
- Conditions
- Inflammatory Bowel Diseases, Anorectal Malformations, Spina Bifida, Ostomy
- Trial name
- StoMakker (NCT06065995)
- Testing
- StoMakker
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ostomy, Quality of Life
A Clinical Feedback System in Ostomy Care
Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects.
- Conditions
- Ostomy, Quality of Life, Adaptation, Psychological
- Trial name
- NCT03841071
- Testing
- ROM/CFS intervention
- Where
- Norway
- Volunteers
- 100 people
- Sponsor
- Helse Forde