Clinical trials: Colostomy Stoma
Peristomal Skin Complication
Preliminary Evaluation of CASTLE Barrier Prototype UK
The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
- Trial name
- NCT01530087
- Testing
- CASTLE barrier
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Hollister Incorporated
Stoma Site Odor
Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals With Colostomy
This study was planned to examine the effects of using the lavender essential oil and peppermint essential oil in stoma bags on odor removal, life satisfaction, and stoma compliance in patients with a stoma.
- Trial name
- surgery (NCT05716711)
- Testing
- LAVENDER OIL
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cukurova University
Colostomy Stoma, Cancer of Colon
ExPECT: Extraperitoneal End Colostomy Trial
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…
- Conditions
- Colostomy Stoma, Cancer of Colon, Surgery, Quality of Life
- Trial name
- ExPECT (NCT05163873)
- Testing
- Extra-peritoneal
- Where
- 3 sites in United Kingdom
- Volunteers
- 23 people
- Sponsor
- Swansea Bay University Health Board
Colostomy Stoma, Ileostomy - Stoma
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
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.
- Conditions
- Colostomy Stoma, Ileostomy - Stoma, Peristomal Skin Complication
- Trial name
- gAOVEstoma (NCT05289765)
- Testing
- A natural neutral Ecological Extra Virgin Olive Oil based gel, A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products
- Where
- 2 sites in Spain
- Volunteers
- 27 people
- Sponsor
- Universidad de Granada
Stoma Colostomy
Performance Study of Newly Developed Ostomy Products
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies.
- Trial name
- NCT01513330
- Testing
- SenSura Mio, Standard Care
- Where
- Germany
- Volunteers
- 122 people
- Sponsor
- Coloplast A/S
Colorectal Cancer, Quality of Life
Peristomal Skin Complications and Quality of Life
This study is a single blind semi-experimental study. Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.
- Conditions
- Colorectal Cancer, Quality of Life, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT04375930
- Testing
- STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dokuz Eylul University
Stoma Ileostomy, Stoma Colostomy
Investigation of a New 1-piece Convex Ostomy Product
The aim of the investigation was to investigate the performance and safety of a new ostomy product
- Trial name
- NCT02043782
- Testing
- Coloplast Test, Own product, Competitor soft convex
- Where
- Denmark
- Volunteers
- 38 people
- Sponsor
- Coloplast A/S
Enterostomy, Stoma Ileostomy
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions…
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT05373888
- Testing
- Flexima®/Softima® stoma bags
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- BBraun Medical SAS
Diverticular Disease of Colon, Colostomy Complication
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
Brief Summary This multicenter study compares the effectiveness of primary anastomosis with diverting loop ileostomy to Hartmann's procedure for managing perforated sigmoid diverticulitis in stable patients.
- Conditions
- Diverticular Disease of Colon, Colostomy Complication, Colostomy - Stoma
- Trial name
- ARES (NCT06794905)
- Volunteers
- 578 people
- Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
Diverticular Disease of Colon, Colostomy - Stoma
ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis
This observational study was conducted across five surgical centers in Italy, including both academic and community hospitals, from January 2017 to December 2022.
- Conditions
- Diverticular Disease of Colon, Colostomy - Stoma, Loop Ileostomies
- Trial name
- ARES (NCT07094594)
- Where
- Italy
- Volunteers
- 578 people
- Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
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
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
Stoma Colostomy, Nursing Caries
Flipped Learning Model on the Stoma Care
This study is planned as a randomized controlled trial to determine the effect of education provided through the flipped learning model on students' levels of knowledge and self-efficacy regarding stoma care.
- Conditions
- Stoma Colostomy, Nursing Caries, Nursing Student
- Trial name
- Stomacare (NCT06397534)
- Testing
- Education
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ankara Yildirim Beyazıt 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
Hernia, Colostomy Stoma
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection
This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.
- Trial name
- NCT04793009
- Testing
- funnel-shaped, intraperitoneal mesh placement
- Volunteers
- 76 people
- Sponsor
- Walter Brunner
Colostomy - Stoma, Ileostomy - Stoma
The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation
The majority of patients (60-70%) develop high levels of anxiety before surgery. Surgical patients may experience feelings of anxiety due to insufficient information and counseling before surgery and potential changes in the body…
- Trial name
- NCT06737887
- Testing
- Stoma simulation
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people
- Sponsor
- Kocaeli University
Hernia, Stoma Colostomy
Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China
Parastomal hernia refers to the protrusion of the area around the stoma or the ectopic protrusion of abdominal contents from the stoma (colostomy, ileostomy, ileostomy for bladder) in the abdominal wall defect.
- Trial name
- NCT05061589
- Testing
- permanent colostomy
- Where
- 2 sites in China
- Volunteers
- 712 people
- Sponsor
- Beijing Friendship Hospital
Colorectal Neoplasms, Parastomal Hernia
Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy
TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ".
- Conditions
- Colorectal Neoplasms, Parastomal Hernia, Colostomy Stoma
- Trial name
- LONGCROSS (NCT04397783)
- Testing
- construction of an end colostomy
- Where
- 2 sites in Spain
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hospital Donostia
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
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