Clinical trials: Ileostomy - Stoma
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
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 Neoplasm
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions: 1.
- Trial name
- LISTO (NCT02669992)
- Testing
- Stapled or Hand-sewn anastomosis, Mesh or suture stoma site closure
- Where
- 11 sites in Sweden
- Volunteers
- 400 people
- Sponsor
- Karolinska University Hospital
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
Stoma Ileostomy, Stoma Colostomy
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- Trial name
- StomaCare (NCT05076669)
- Testing
- stoma follow-up, standard of care
- Where
- 10 sites in France
- Volunteers
- 350 people
- Sponsor
- FSK
Stoma Ileostomy, Ileostomy; Complications
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy…
- Trial name
- NCT06461559
- Testing
- antegrade infusion of ileostomy content
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Diego
Ileostomy - Stoma, Rectal Neoplasms
Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy
In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection.
- Trial name
- NCT06344923
- Testing
- Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing, Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Hospital of Shandong University
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
Bowel Obstruction, Bowel Ischemia
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of…
- Conditions
- Bowel Obstruction, Bowel Ischemia, Diverticulitis, Abnormality of the Gastrointestinal Tract
- Trial name
- NCT04709445
- Testing
- ICG-NIRF Imaging plus ingress and egress analysis
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Ileostomy - Stoma, Colostomy Stoma
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
The study investigates the performance of a new adhesive with regard to the skin condition
- Trial name
- NCT03770078
- Testing
- Test Product A
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 23 people
- Sponsor
- Coloplast A/S
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
Incisional Hernia, Surgical Site Infection
Prophylactic Mesh Reinforcement for Stoma Closure
In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection …
- Conditions
- Incisional Hernia, Surgical Site Infection, Postoperative Pain, Hospital Stay, Length of Stay in Hospital From Surgery to Discharge
- Trial name
- OASIS (NCT06157645)
- Testing
- Prolene mesh
- Where
- Egypt
- Volunteers
- 62 people
- Sponsor
- Assiut University
Ileostomy - Stoma, Rectal Cancer
Early Ileostomy Closure for Rectal Cancer Patients in North America
Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop…
- Trial name
- NCT05027737
- Testing
- Early Ileostomy Closure
- Where
- 4 sites in Canada
- Volunteers
- 118 people
- Sponsor
- Jewish General Hospital
Ileostomy - Stoma
Broccoli Ileo Study
Epidemiological and experimental studies have indicated that the consumption of diets rich in cruciferous vegetables such as broccoli has a range of beneficial effects on human health.
- Trial name
- NCT04113928
- Testing
- Broccoli & mustard seed soup, Broccoli soup
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Colonic Neoplasms, Ileostomy - Stoma
Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer
Colorectal cancer worldwide is the third most common in men and the second in female, although mortality is not as high as its incidence, there is less survival in developing countries.
- Conditions
- Colonic Neoplasms, Ileostomy - Stoma, Colorectal Surgery
- Trial name
- NCT03746353
- Testing
- early ileostomy closure
- Where
- 3 sites in Colombia
- Volunteers
- 52 people
- Sponsor
- Instituto Nacional de Cancerologia, Columbia
Colostomy Stoma
Ostomy Telehealth For Cancer Survivors
The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to…
- Trial name
- PCORI (NCT02974634)
- Testing
- Ostomy self management training
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- University of Pennsylvania
Ileostomy
One Piece Drainable Pouch in Subjects With an Ileostomy
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
- Trial name
- NCT01939106
- Testing
- One Piece Drainable Pouch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- ConvaTec Inc.
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
Ileostomy, Colorectal Surgery
Early vs Standard Ileostomy Reversal
This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.
- Trial name
- NCT07601594
- Testing
- Ileostomy reversal
- Where
- Pakistan
- Volunteers
- 90 people
- Sponsor
- Gulab Devi Hospital
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