Clinical trials: Stoma Ileostomy
Rectal Cancer, Ileostomy; Functional Disturbance
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage.
- Trial name
- GRECCAR17 (NCT05233787)
- Testing
- Tailored use of defunctioning stoma after TME, Systematic use of defunctioning stoma
- Where
- 28 sites in France
- Volunteers
- 212 people
- Sponsor
- University Hospital, Bordeaux
Stoma Colostomy, Stoma Ileostomy
The Impact of Education Using a Stoma Care Training Belt
Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and…
- Trial name
- NCT06391398
- Testing
- Stoma care education with the Stoma Care Training Belt
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 170 people
- Sponsor
- Ankara University
Rectal Neoplasms, Low Anterior Resection
Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer
Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR).
- Trial name
- CTI (NCT02012023)
- Testing
- Low anterior resection, tube ileostomy, loop ileostomy
- Where
- China
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Colostomy Stoma, Ileostomy Stoma
The Influence of Baseplate Adhesive on the Degree of Leakage
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
- Trial name
- NCT01995357
- Testing
- Coloplast Test A, Coloplast Test B, Standard product
- Where
- Denmark
- Volunteers
- 22 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Cocoa Ileostomy Study
There is substantial interest in the potential role of chocolate and its primary bioactive component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of cardiovascular disease (CVD).
- Trial name
- NCT03765606
- Testing
- Cocoa Flavanol beverage mix, De-xanthinated Cocoa Flavanol beverage mix
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.
- Trial name
- NCT02886455
- Testing
- Standard adhesive strip, New adhesive strip
- Where
- Denmark
- Volunteers
- 4 people
- Sponsor
- Coloplast A/S
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
- NCT07376421
- Testing
- Incestigational device, Comparator
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon
1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.
- Trial name
- NCT05891041
- Where
- Denmark
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Ileostomy - Stoma
Evaluation of the Performance of an Adhesive Strip
This study investigated the performance of a new adhesive strip when impacted by output
- Trial name
- NCT03419013
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 7 people
- Sponsor
- Coloplast A/S
Ostomy, Enterocutaneous Fistula
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients.
- Trial name
- NCT06524401
- Testing
- Limpet, Control
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- HealthPartners Institute
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Covered by Adhesives
The study investigates the impact real output has on peristomal skin covered by two different adhesives
- Trial name
- NCT03000881
- Testing
- standard adhesive, New adhesive strip
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.
- Trial name
- CP257 (NCT02887144)
- Testing
- SenSura, SenSura test product
- Where
- Denmark
- Volunteers
- 72 people
- Sponsor
- Coloplast A/S
Ileostomy
A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
The traditional positioning and surgical methods for temporary ileostomy no longer meet the requirements of minimally invasive surgery: (1) Conventional stoma positioning often leads to the trocar incision being too close to the…
- Trial name
- FUSION (NCT06604052)
- Testing
- Reduced-Port Fusion Surgery, Traditional surgery
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Stoma Colostomy, Stoma Ileostomy
Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in…
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Caregiver, Self Care
- Trial name
- NCT06269276
- Testing
- Caregiver Contribution to Self-Care in Ostomy Patient Index
- Where
- Turkey (Türkiye)
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- Namik Kemal 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
Stoma Ileostomy
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Electrolyte Depletion, Stoma Ileostomy
Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
Oral sodium supplementation is currently administered in cases of poor weight gain in infants particularly in patients who have undergone gastrointestinal surgical procedures.
- Conditions
- Electrolyte Depletion, Stoma Ileostomy, Stoma Colostomy, Growth Failure
- Trial name
- USALTI (NCT03016195)
- Where
- United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Ileostomy - Stoma
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
- Trial name
- NCT01957553
- Testing
- Coloplast test product, SenSura
- Where
- 17 sites in Belgium, Denmark and 3 more
- Volunteers
- 130 people
- Sponsor
- Coloplast A/S
Incisional Hernia
Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh
Background: Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure.
- Trial name
- PROMESH (NCT04510558)
- Testing
- Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position, Stoma closure without mesh
- Where
- Switzerland
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Stoma Site Leakage, Quality of Life
The Nordic Consensus Study
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.
- Conditions
- Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy
- Trial name
- NCS (NCT04763863)
- Testing
- Body Assessment Tool, Clinical usability evaluation of the Body Assessment Tool
- Where
- Denmark
- Volunteers
- 121 people
- Sponsor
- Coloplast A/S