Clinical trials: Stoma
Ostomy
Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e.
- Trial name
- QoLMio (NCT04635215)
- Testing
- Sensura Mio Bodyfit technology ostomy pouches
- Where
- 78 sites in France
- Volunteers
- 195 people
- Sponsor
- Laboratoires Coloplast S.A.S
Irritant Dermatitis, Stoma Site Dermatitis
Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture (MASD) compared to usual wound care treatment.
- Conditions
- Irritant Dermatitis, Stoma Site Dermatitis, Wound of Skin
- Trial name
- ISR-CASP-MASD (NCT06178289)
- Testing
- 3M Cavilon Advanced Skin Protectant, Standard hospital wound treatment protocol
- Where
- 3 sites in Belgium
- Volunteers
- 36 people
- Sponsor
- University Ghent
Stoma Ileostomy
Clinical Investigation Exploring Two Ostomy Product Prototypes
Two ostomy product prototypes (Test product A and B) will be tested in this investigation. All subjects will test both Test product A and B, with a minimum of 7 days apart.
- Trial name
- NCT06237686
- Testing
- CP363
- Where
- Denmark
- Volunteers
- 11 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
- Trial name
- NCT03619226
- Testing
- test patch
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
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
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
Diverticular Disease of Colon, Colostomy Complication
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
Brief Summary This multicenter study compares the effectiveness of primary anastomosis with diverting loop ileostomy to Hartmann's procedure for managing perforated sigmoid diverticulitis in stable patients.
- Conditions
- Diverticular Disease of Colon, Colostomy Complication, Colostomy - Stoma
- Trial name
- ARES (NCT06794905)
- Volunteers
- 578 people
- Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
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
Stoma Site Infection
Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal
Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management…
- Trial name
- NESTOR (NCT03781206)
- Testing
- PICO™ 7
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Istituto Clinico Humanitas
Stoma Colostomy, Stoma Ileostomy
Management Of Stoma In Patients Younger Than 3 Months Old
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also…
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Neonatal Disease
- Trial name
- STOMP (NCT06458699)
- Where
- France
- Volunteers
- 82 people
- Sponsor
- University Hospital, Clermont-Ferrand
Surgical Adhesions, Blood Loss, Surgical
Pilot Study Differential Dissector™ for Blunt Dissection
The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the…
- Trial name
- NCT02382952
- Testing
- Differential Dissector, Standard Dissection Method
- Sponsor
- University of North Carolina, Chapel Hill
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
Rectal Cancer
Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better…
- Trial name
- NCT03487484
- Testing
- Quality of Life Questionnaire for gastrointestinal tract, Quality of Life Questionnaire, Faecal Incontinence Score
- Where
- Switzerland
- Volunteers
- 5 people
- Sponsor
- University Hospital, Basel, Switzerland
Neoplasms Malignant, Rectal Cancer
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair.
- Conditions
- Neoplasms Malignant, Rectal Cancer, Hernia Incisional, Surgery
- Trial name
- ProMeLAR (NCT05939687)
- Testing
- mesh, non-mesh
- Where
- Russia
- Volunteers
- 142 people
- Sponsor
- Blokhin's Russian Cancer Research Center