Clinical trials: Ileostomy, active
Stoma - Ileostomy
Feasibility of a Newly Developed Ostomy Prototype
Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life.
- Trial name
- NCT07146035
- Testing
- CP369 Feasibility of a newly developed ostomy prototype (only one intervention)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Coloplast A/S
Rectal Cancer
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
This study aims to propose a novel, easy-to-operate intervention strategy that effectively improves defecation function after stoma reversal and to assess its impact on the gut microbiota.The efficacy and safety of antegrade…
- Trial name
- NCT07369830
- Testing
- Clostridium butyricum (live) Tablets(Meiya)
- Where
- China
- Volunteers
- 156 people
- Sponsor
- Huashan Hospital
Ileostomy - Stoma, Colorectal Surgery
Readmission and Dehydration Prevention in Patients With Elective Ileostomy
The goal of this prospective observational study is to evaluate the adherence to DRIP score calculation and the application rate of each proposed item to prevent dehydration and readmission in patients undergoing ileostomy…
- Conditions
- Ileostomy - Stoma, Colorectal Surgery, Dehydration
- Trial name
- PREDESTO (NCT06824623)
- Where
- 7 sites in Italy
- Volunteers
- 300 people
- Sponsor
- Multidisciplinary Italian Study group for STOmas (MISSTO)
Ileostomy - Stoma
Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery
This study compares the Enhanced Recovery After Surgery (ERAS) protocol to traditional postoperative care in pediatric patients undergoing elective ileostomy reversal.
- Trial name
- NCT07821138
- Testing
- ERAS protocol, Traditional care
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Children Hospital Faisalabad
Ileostomy - Stoma, Colostomy - Stoma
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
stoma creation is a traumatic experience for patients, effect on patients significant others and partners is not well understood.
- Conditions
- Ileostomy - Stoma, Colostomy - Stoma, Urostomy Patent
- Trial name
- NCT07787637
- Testing
- resiliency training
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Northwestern University
Stoma Care Education in Nursing Students, Gamification
Gamification in Stoma Care Education for Nursing Students
his study aims to determine the effect of a gamification-based educational method on nursing students' learning of stoma care. The research will be conducted as a pretest-posttest, parallel-group randomized controlled…
- Conditions
- Stoma Care Education in Nursing Students, Gamification, Nursing Education, Ostomy - Ileostomy or Colostomy
- Trial name
- GAME-STOMA (NCT07500857)
- Testing
- Gamification-Based Stoma Care Education, Traditional Education
- Volunteers
- 72 people
- Sponsor
- Gazi University
Ileostomy - Stoma, Caregiver
The Effect of Real Patient Interactive Stoma Care Management Teaching
Colorectal cancer is a type of cancer that is on the rise worldwide. Ileostomy with surgical treatment is one of the common treatment methods for this cancer.
- Conditions
- Ileostomy - Stoma, Caregiver, Care Management, Care Participation
- Trial name
- NCT06979102
- Testing
- Real Patient Interactive Stoma Care Management Teaching, Standard Stoma Care Management Teaching
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hacettepe University
Obesity, Surgery
Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch
The aim of the Torsby I Trial is to identify differences and similarities between a standard duodenal switch (DS) and a single-anastomosis duodeno-ileostomy (SADI) regarding effect on weight, comorbidities and malnutrition.
- Conditions
- Obesity, Surgery, Metabolic Syndrome, Malnutrition
- Trial name
- NCT03938571
- Testing
- Duodenal Switch
- Volunteers
- 56 people
- Sponsor
- Värmland County Council, Sweden
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
Crohns Disease
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments.
- Trial name
- NCT06670638
- Where
- 5 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Alimentiv Inc.
Colo-rectal Cancer, Colo-rectal Surgery
Post Operative Hospital at Home After Colorectal Surgery
The goal of this feasibility study is to investigate whether a virtual Hospital at Home is safe and possible for patients undergoing planned minimally invasive colorectal surgery.
- Conditions
- Colo-rectal Cancer, Colo-rectal Surgery, Colocolic and Ileocolic Anastomosis, Colon and/or Rectal Resection With Anastomosis for Cancer
- Trial name
- POPHaH (NCT07113717)
- Testing
- virtual Hospital at Home
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Nordsjaellands Hospital
Ileostomy - Stoma
Digestibility of Different Plant-based Proteins in Humans With Ileostomy
The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy. The main questions the study aims to answer are: 1.
- Trial name
- PAN-Prodig (NCT06142084)
- Testing
- Oat Protein, low bioavailability, Oat Protein, high bioavailability, Pea Protein, low bioavailability
- Where
- Sweden
- Volunteers
- 11 people
- Sponsor
- Örebro University, Sweden
Ulcerative Colitis, Ileal Pouch
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool.
- Trial name
- NCT07501078
- Testing
- Aquamin
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Muhammad N Aslam, MD
Ostomy - Ileostomy or Colostomy, Stoma Complications
Suture Choice for Ostomy Creation
The goal of this clinical trial is to learn whether chromic gut or polyglactin 910 suture results in fewer stoma complications when used to mature an enterostomy in patients undergoing planned ostomy creation.
- Conditions
- Ostomy - Ileostomy or Colostomy, Stoma Complications, Stoma Site Dermatitis, Stoma Site Infection
- Trial name
- NCT07900711
- Testing
- Chromic Gut Suture, Polyglactin 910 Suture
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Southern California
Loop Ileostomy
Prevention of Hernia After Loop Ileostomy Reversal
PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro Advanced or standard treatment without mesh.
- Trial name
- PHaLIR (NCT03720262)
- Testing
- Mesh reinforcement, No reinforcement
- Where
- 4 sites in Sweden
- Volunteers
- 208 people
- Sponsor
- Karolinska Institutet
Stoma Closure, Postoperative Pain
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure
After stoma closure, pain remains an important problem affecting patient recovery. A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed…
- Conditions
- Stoma Closure, Postoperative Pain, Quality of Recovery
- Trial name
- r-PVB III (NCT07571902)
- Testing
- Revised-Paravertebral Nerve Block
- Volunteers
- 250 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Ileostomy Stoma, Stoma Stimulation
Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings
BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection.
- Conditions
- Ileostomy Stoma, Stoma Stimulation, Microbiome Analysis
- Trial name
- STIMIC (NCT07640113)
- Testing
- Serum stimulation, Physiological stimulation
- Volunteers
- 90 people
- Sponsor
- Hospital Clinic of Barcelona
Stoma Colostomy, Stoma Ileostomy
Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy.
- Trial name
- PROSPERITY (NCT06650085)
- Testing
- Loop ileostomy, Loop colostomy
- Where
- 3 sites in Finland
- Volunteers
- 350 people
- Sponsor
- Helsinki University Central Hospital
Stoma Ileostomy
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas.
- Trial name
- NCT06554015
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Coloplast A/S
Rectal Cancer Patients
Preoperative Nasal Intestinal Obstruction Catheter Mediated Terminal Ileum Fecal Diversion Versus Intraoperative Protective Ileostomy for Preventing Anastomotic Leakage After Mid Low Rectal Cancer Surgery: A Non Inferiority, Prospective, Multicenter Randomized Controlled Trial
We are currently conducting a multicenter randomized controlled clinical trial entitled *Preoperative Nasal Placement of Bowel Obstruction Catheter for Terminal Ileum Fecal Diversion versus Intraoperative Protective Ileostomy in…
- Trial name
- NCT07821437
- Testing
- Preoperative oral placement of bowel obstruction catheter
- Volunteers
- 500 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University