Clinical trials: Stoma Ileostomy
Diverting Ileostomy, Rectal Cancer
Purse-String Versus Linear Closure After Ileostomy Reversal
This randomized study compared two wound closure and wound care protocols after reversal of a diverting ileostomy in adults previously treated surgically for rectal cancer.
- Trial name
- NCT07892404
- Testing
- Linear Wound Management Protocol, Purse-String Wound Management Protocol
- Where
- Ukraine
- Volunteers
- 23 people
- Sponsor
- Dnipro Regional Clinical Oncology Dispensary
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)
This study investigates the impact real output has on peristomal skin covered by an adhesive
- Trial name
- NCT02992444
- Testing
- Standard adhesive strip, Experimental adhesive strip
- Where
- Denmark
- Volunteers
- 5 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma, Colostomy - Stoma
A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy
This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or…
- Trial name
- TIES IV (NCT07413822)
- Testing
- TIES® Transcutaneous Implant Evacuation System
- Volunteers
- 10 people
- Sponsor
- Asian Institute of Gastroenterology, India
Ileostomy - Stoma, Ileostomy; Complications
Laparoscopic Surgery of Rectal Cancer and Ileostomy
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of…
- Conditions
- Ileostomy - Stoma, Ileostomy; Complications, Leakage, Anastomotic
- Trial name
- NCT04169425
- Testing
- elective diverting ileostomy
- Volunteers
- 150 people
- Sponsor
- Campus Bio-Medico University
Stoma Colostomy, Stoma Ileostomy
The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma
Stoma is a surgical intervention to ensure that body wastes are removed differently from the normal physiological opening. The stoma patient has to cope with complex emotional, social and physical problems associated with this…
- Trial name
- NCT05601024
- Testing
- Laughter Therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people
- Sponsor
- Istanbul University - Cerrahpasa
Stoma Ileostomy
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
- Trial name
- NCT01994902
- Testing
- Coloplast test product, SenSura Convex Light
- Where
- 29 sites in Denmark, France and 3 more
- Volunteers
- 129 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
- Trial name
- NCT01994876
- Testing
- Coloplast Test 1, Coloplast Test 2
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Coloplast A/S
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
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
Ileostomy - Stoma, Colostomy Stoma
A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative…
- Trial name
- NCT03707392
- Testing
- Ostomy Education Video, Control - Standard ostomy education
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Stoma Ileostomy
Evaluation of the Peel Force of New Adhesives From the Skin
This study investigates the impact and adhesion of new adhesives to the skin.
- Trial name
- NCT03200444
- Testing
- Standard adhesive 1, Standard adhesive 2, Standard adhesive 3
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
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
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
Ileostomy - Stoma, Ileostomy; Complications
Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system.
- Trial name
- NCT03982875
- Testing
- Alfred SmartBag
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- 11 Heath and Technologies Limited
Ileostomy - Stoma, Ileostomy; Complications
Evaluating Ileostomy Hydration Protocol
This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert Packer Hospital.
- Conditions
- Ileostomy - Stoma, Ileostomy; Complications, Dehydration
- Trial name
- NCT04669964
- Testing
- Intravenous Hydration
- Where
- United States
- Sponsor
- The Guthrie Clinic
Ileostomy - Stoma
Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications
The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing readmission rates of subjects with new ileostomies in the first 30 days post-operatively.
- Trial name
- NCT02694757
- Testing
- Ostom-i device
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Massachusetts General Hospital
Ileostomy - Stoma, Ileus
Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage.
- Conditions
- Ileostomy - Stoma, Ileus, Rectal Cancer, Surgical Complication
- Trial name
- Ileostim (NCT05302557)
- Testing
- Ileostomy stimulation
- Where
- Spain
- Volunteers
- 68 people
- Sponsor
- Universidad de León
Incisional Hernia, Ileostomy - Stoma
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak.
- Trial name
- NCT06511414
- Testing
- duramesh, Control
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Northwestern University
Rectal Cancer, Total Mesorectal Excision
Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
The purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).
- Conditions
- Rectal Cancer, Total Mesorectal Excision, Ileostomy - Stoma, Ileostomy; Complications
- Trial name
- TIMES (NCT05284864)
- Testing
- Stoma closure
- Where
- 9 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Hospital Universitario La Fe
Ileostomy; Complications
"Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the…
- Trial name
- NCT06010043
- Testing
- Suturing of ileostomy using "Dumpling suture method", Suturing of ileostomy using Traditional suture method
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine