Clinical trials: Ileostomy
Ileostomy - Stoma
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
- Trial name
- NCT03416023
- Testing
- TIES® (Transcutaneous Implant Evacuation System)
- Where
- 4 sites in Sweden, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Ostomycure AB
Stoma Colostomy, Stoma Ileostomy
Outcomes of Midline Stoma
Ileostomy or colostomy is a common surgical procedure used for diverting the lower gastrointestinal content away from distal pathology or anastomotic insufficiency.
- Trial name
- NCT07616830
- Testing
- Midline stoma
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Assiut University
LARS - Low Anterior Resection Syndrome
The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation…
- Trial name
- NCT07082699
- Testing
- antegrade enema, retrograde enema
- Volunteers
- 72 people
- Sponsor
- Sichuan Cancer Hospital and Research Institute
Ileostomy, Rectal Cancer
The Stoma Closure Before or After Adjuvant Therapy Trial
This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it).
- Trial name
- STOMAD (NCT04372992)
- Testing
- Timing of stoma closure
- Where
- 28 sites in Italy
- Volunteers
- 14 people
- Sponsor
- Ospedale Umberto I di Torino
Rectal Neoplasms, Ostomy
Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy
The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.
- Conditions
- Rectal Neoplasms, Ostomy, Neoplasms
- Trial name
- LIVELOC (NCT05745909)
- Testing
- Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy, Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy
- Where
- Russia
- Volunteers
- 150 people
- Sponsor
- Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
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
Ileostomy
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing.
- Trial name
- U366 (NCT01782196)
- Testing
- Enhanced one piece drainable pouch with Type A mouldable adhesive, Enhanced one piece drainable pouch with Type B mouldable adhesive
- Where
- 5 sites in United Kingdom
- Volunteers
- 13 people
- Sponsor
- ConvaTec Inc.
Obesity, Type 2 Diabetes
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI…
- Trial name
- NCT07085741
- Testing
- MAGNET System, DI Biofragmentable
- Where
- Mexico
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
Healthy Volunteer, Terminal Ileostomy
Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract.
The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus salivarius, in the digestive tract of healthy volunteers and of ileostomized patients, depending on its galenic form.
- Trial name
- PROBIOSIN (NCT03143400)
- Testing
- Lactobacillus salivarius BL 3123
- Where
- France
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand
Healthy Volunteers
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
- Trial name
- NCT02419001
- Testing
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB
- Where
- 3 sites in United States, Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Rectal Cancer
Early Closure of Temporary Ileostomy
The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer.
- Trial name
- EASY (NCT01287637)
- Testing
- Early reversal of temporary ileostomy, Standard reversal of temporary ileostomy
- Where
- Denmark
- Volunteers
- 89 people
- Sponsor
- Herlev Hospital
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
Colostomy Stoma, Ileostomy - Stoma
Needle-Aspirated Compression Dressing Following Ostomy Reversal
Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections.
- Conditions
- Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection, Wound Complication
- Trial name
- NCT03703661
- Testing
- Needle-Aspirated Negative Pressure Dressing, Control
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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
Colorectal Cancer, Bladder Cancer
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- PRISMS (NCT04492007)
- Testing
- Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
Ileostomy
Reducing Readmissions in High-Risk Ostomates
Preventing complications and readmission after ostomy surgery will decrease the cost of healthcare, improve patient safety, reduce the cost of durable medical equipment required by ostomates, ensure continued specialized care is…
- Trial name
- NCT02658123
- Testing
- Pre-operative education (standard of care), Home health care visits (standard of care), Follow-up post-operative visits
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Washington University School of Medicine
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
Colostomy - Stoma, Ileostomy - Stoma
Effects of Stoma Education on Patients
tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are…
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma, Patient Education, Body Image
- Trial name
- Stoma (NCT07464548)
- Testing
- Teach-Back Education
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Munzur University
Colo-rectal Cancer
Reversal of a Defunctioning Ileostomy 3 Weeks After the Index Operation, RCT
Diverting ileostomy seems to mitigate the consequences of anastomotic leak from low rectal anastomosis. Gastrointestinal continuity is restored after a period of 6-12 weeks but it can be longer if the patient is on adjuvant…
- Trial name
- NCT05192018
- Testing
- Early reversal of a defunctiong ileostomy
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute, Egypt