Clinical trials: Enterostomy
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
Enterostomy
A Study of Using the Stoma Self-care Apps by Patients With Enterostomy
This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation…
- Trial name
- NCT06855082
- Testing
- stoma self-care apps, Traditional Education Receive colostomy health education manual with oral instruction
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- HSIN LING CHEN
Short Bowel Syndrome, Necrotizing Enterocolitis
Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen).
- Conditions
- Short Bowel Syndrome, Necrotizing Enterocolitis, Small Intestine Perforation
- Trial name
- EMLFO (NCT01306838)
- Testing
- MicroLipid and fish oil, Routine care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University
Malignant Gastric Outlet Obstruction
Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction
Malignant gastric outlet obstruction is a very disabling complication of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis.
- Trial name
- NCT04810377
- Testing
- EUS-guided gastroenterostomy
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Enterostomy
Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal…
- Trial name
- NCT02812095
- Testing
- Refeeding
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Seoul National University Hospital
Colorectal Cancer
Construction and Empirical Research of the Applicable Baduanjin Protocol for Patients With Colorectal Cancer Enterostomy
The goal of this clinical trial is to understand the application effect of the applicable version of Baduanjin protocol in patients with enterostomy and verify the safety and efficacy of this protocol.
- Trial name
- NCT07172087
- Testing
- Baduanjin for patients with enterostomy
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Sichuan Cancer Hospital and Research Institute
Enterostomy
Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment
During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure.
- Trial name
- SOMILEO (NCT02713776)
- Testing
- Pasireotide
- Where
- 14 sites in France
- Volunteers
- 57 people
- Sponsor
- Hospices Civils de Lyon
Multimedia Learning Education, Self-care
The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.
- Conditions
- Multimedia Learning Education, Self-care, Quality of Life, Enterostomy
- Trial name
- NCT04966286
- Testing
- multimedia education
- Where
- Taiwan
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Enterostomy
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
- Trial name
- NCT02507726
- Testing
- Flexima Active soft convexe
- Where
- France
- Volunteers
- 40 people
- Sponsor
- BBraun Medical SAS
Enterostomy, Elderly
The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients
The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies.
- Conditions
- Enterostomy, Elderly, Self-management, Education
- Trial name
- NCT06392646
- Testing
- self-management education program
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Wuxi No. 2 People's Hospital
Nutrition of Ileostomy Infants
Enteral Nutrition in Infants With Ileostomy
This study is a prospective, single center, practical, and observational open clinical study.
- Trial name
- NCT04707443
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Children's Hospital of Fudan University
Enterostomy
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of…
- Trial name
- MUC-FIRE (NCT03469609)
- Testing
- mucous fistula refeeding
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Necrotizing Enterocolitis
Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis
Necrotizing enterocolitis (NEC) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns.
- Trial name
- NCT04912453
- Testing
- Primary anastomosis, Enterostomy
- Where
- Hong Kong
- Volunteers
- 90 people
- Sponsor
- The University of Hong Kong
Enterostomy
Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
- Trial name
- NCT03572673
- Testing
- Flexima 3S, New 2-piece ostomy appliance
- Where
- 2 sites in Malaysia
- Volunteers
- 38 people
- Sponsor
- BBraun Medical SAS
Ileus, Post-Operative Adhesions
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel…
- Trial name
- PROFILE (NCT02836470)
- Testing
- LB1148
- Where
- 28 sites in United States
- Volunteers
- 112 people
- Sponsor
- Palisade Bio
Colorectal Neoplasms, Colorectal Surgery
Attitudes and Technical Maneuvers Regarding Enterostomy Management and Stoma Creation Among Surgeons
This study was aiming to investigate Chinese surgeons' attitudes toward and technical preferences for stoma creation.
- Trial name
- NCT06735729
- Where
- China
- Volunteers
- 401 people
- Sponsor
- Peking University Cancer Hospital & Institute
Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation
Intestinal Colonization in Newborn Infants With Enterostomy
The human microbiota, a collection of microorganisms mostly settled in the gastrointestinal tract, plays a major role in the maintenance of the hosts' health and in development of disease as well.
- Trial name
- NCT03340259
- Testing
- Exposure(s) of interest: enterostomy
- Where
- Portugal
- Volunteers
- 30 people
- Sponsor
- Universidade do Porto
Intestinal Failure, Enterocutaneous Fistula
Chyme Reinfusion for Type 2 Intestinal Failure
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas.
- Conditions
- Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma, High Output Stoma
- Trial name
- REINFUSE (NCT04577456)
- Testing
- The Insides System
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 44 people
- Sponsor
- The Insides Company
Intestinal Failure With a Temporary High-output Double Enterostomy
Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)
In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity.
- Trial name
- FRY (NCT02792543)
- Testing
- Entéromate™, parenteral nutrition
- Where
- France
- Volunteers
- 268 people
- Sponsor
- Hospices Civils de Lyon
Double Enterostomy
Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy
Multicentre prospective human experimental study to determine the effect of chyme reinfusion in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)
- Trial name
- RESCUE (NCT02990195)
- Testing
- Chyme reinfusion
- Where
- 3 sites in France, Netherlands
- Volunteers
- 13 people
- Sponsor
- Rennes University Hospital