Clinical trials: Colostomy Stoma
Perianal Dermatitis, Diaper Dermatitis
Perianal Maceration in Pediatric Ostomy Closure Patients
This pilot study will explore whether preoperative application of stool from the stoma bag to the perianal area will prevent/ decrease postoperative perianal maceration in pediatric ostomy closure patients.
- Conditions
- Perianal Dermatitis, Diaper Dermatitis, Postoperative Complications, Colostomy Site
- Trial name
- NCT04606004
- Testing
- Stool application, Standard of care skincare
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Pittsburgh
Hernia, Colostomy Stoma
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection
This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.
- Trial name
- NCT04793009
- Testing
- funnel-shaped, intraperitoneal mesh placement
- Volunteers
- 76 people
- Sponsor
- Walter Brunner
Quality of Life, Stoma Ileostomy
QoL of Colorectal Cancer Patients and Spouses
The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses.
- Conditions
- Quality of Life, Stoma Ileostomy, Stoma Colostomy, Rectum Cancer
- Trial name
- NCT04744792
- Testing
- Short Form - 36, WHODAS-II
- Volunteers
- 200 people
- Sponsor
- Cihangir Akyol
Rectal Neoplasms, Quality of Life
Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score
The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life.
- Conditions
- Rectal Neoplasms, Quality of Life, Colostomy Stoma
- Trial name
- NCT03516916
- Testing
- Questionnaires on HRQoL and sociodemography
- Where
- Denmark
- Volunteers
- 3,750 people
- Sponsor
- Aarhus University Hospital
Stoma Colostomy, Stoma Ileostomy
The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
The incidence of peristomy skin complication ranges from 15% to 65%. It is a serious issue and problem for patients care.The type of skin barrier is associated with peristomy skin complication.
- Trial name
- NCT04202666
- Testing
- convex skin barrier
- Where
- Taiwan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Rectal Neoplasms, Colostomy Stoma
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an…
- Conditions
- Rectal Neoplasms, Colostomy Stoma, Quality of Life
- Trial name
- NCT04141566
- Testing
- Perineal pseudocontinent colostomy, Permanent left iliac colostomy
- Where
- Morocco
- Volunteers
- 35 people
- Sponsor
- Moroccan Society of Surgery
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
Colorectal Neoplasms, Parastomal Hernia
Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy
TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ".
- Conditions
- Colorectal Neoplasms, Parastomal Hernia, Colostomy Stoma
- Trial name
- LONGCROSS (NCT04397783)
- Testing
- construction of an end colostomy
- Where
- 2 sites in Spain
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hospital Donostia
Chronic Radiation Proctitis, Rectal Bleeding
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does not respond to medical treatments including reagents, endoscopic argon plasma coagulation (APC) or topical formalin.
- Conditions
- Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma, Anemia
- Trial name
- NCT03397901
- Testing
- Transverse colostomy
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Colostomy Stoma
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds.
- Trial name
- NCT02544061
- Testing
- NM-IL-12
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Neumedicines Inc.
Colostomy Stoma, Ileostomy - Stoma
Needle-Aspirated Compression Dressing Following Ostomy Reversal
Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections.
- Conditions
- Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection, Wound Complication
- Trial name
- NCT03703661
- Testing
- Needle-Aspirated Negative Pressure Dressing, Control
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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
Colostomy Stoma
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Trial name
- NCT03108105
- Testing
- AOS-C2001-B
- Where
- France
- Volunteers
- 30 people
- Sponsor
- BBraun Medical SAS
Colostomy, Ileostomy - Stoma
Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy
The purpose of this study is to use routinely-collected health data from registers to examine the incidence of parastomal bulging (PB) at different time points in the first year after surgery for ileostomy or colostomy.
- Conditions
- Colostomy, Ileostomy - Stoma, Enterostomy
- Trial name
- NCT02811926
- Volunteers
- 5,019 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Electrolyte Depletion, Stoma Ileostomy
Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies
Oral sodium supplementation is currently administered in cases of poor weight gain in infants particularly in patients who have undergone gastrointestinal surgical procedures.
- Conditions
- Electrolyte Depletion, Stoma Ileostomy, Stoma Colostomy, Growth Failure
- Trial name
- USALTI (NCT03016195)
- Where
- United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Ileostomy - Stoma, Colostomy - Stoma
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
- Trial name
- NCT01957462
- Testing
- Coloplast Test V, Coloplast Test X
- Where
- Denmark
- Volunteers
- 31 people
- 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
Colostomy Stoma, Ileostomy Stoma
The Influence of Baseplate Adhesive on the Degree of Leakage
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
- Trial name
- NCT01995357
- Testing
- Coloplast Test A, Coloplast Test B, Standard product
- Where
- Denmark
- Volunteers
- 22 people
- Sponsor
- Coloplast A/S
Colostomy Stoma
Human Skin Test Model in Colostomists
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin…
- Trial name
- NCT01918085
- Testing
- Hydrocolloid strip, Strata strip
- Volunteers
- 22 people
- Sponsor
- Coloplast A/S
Stoma Colostomy
Performance Study of Newly Developed Ostomy Products
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies.
- Trial name
- NCT01513330
- Testing
- SenSura Mio, Standard Care
- Where
- Germany
- Volunteers
- 122 people
- Sponsor
- Coloplast A/S