Clinical trials: Colostomy
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
Colon Cancer
Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
The aim of this study is to determine whether chemotherapy prior to tumor removal (neoadjuvant chemotherapy), in patients undergoing treatment for colon cancer in occlusion (CCO), would improve the rate of patients able to…
- Trial name
- COnCERTO (NCT06107920)
- Testing
- Neoadjuvant chemotherapy
- Where
- 28 sites in France
- Volunteers
- 232 people
- Sponsor
- University Hospital, Rouen
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
Parastomal Hernia
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
Specific aim: To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
- Trial name
- STOMAMESH (NCT00917995)
- Testing
- Polypropylene Mesh, density 25-40g/square meter
- Where
- Sweden
- Volunteers
- 241 people
- Sponsor
- Norrbottens Lans Landsting
Postoperative Pain
Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure
Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it.
- Trial name
- NCT02691403
- Testing
- levo-bupivacaine, normal saline
- Volunteers
- 50 people
- Sponsor
- Sun Yat-sen University
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
Colorectal Cancer, Bladder Cancer
Connecting Audio and Radio Sensing Systems to Improve Care at Home
This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- AURA (NCT05344950)
- Testing
- Audio + Radio (AURA)
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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
Colostomy
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
- Trial name
- NCT01243294
- Testing
- SS, SenSura
- Where
- Denmark
- Volunteers
- 56 people
- Sponsor
- Coloplast A/S
Ostomy - Ileostomy or Colostomy
The Influence of Adhesive Wafer Design on Fit to the Body
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
- Trial name
- NCT02176954
- Testing
- Test A, Test B, Comparator
- Where
- 10 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Coloplast A/S
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
Colorectal Cancer (CRC)
A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
### Brief Summary Title**: A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery Background**: Colostomy surgery is a common procedure…
- Trial name
- COMPARISON (NCT06674200)
- Testing
- Mesenteric Molding Suturing Group, Regular
- Volunteers
- 11,243 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University