Clinical trials: Colostomy Site
Colorectal Carcinoma
Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons.
- Trial name
- STAPLER (NCT02652702)
- Testing
- circular stapler-assisted colostomy, conventional hand-stitching colostomy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Zhejiang University
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
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
Rectal Cancer, Rectal Tumor
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
- Conditions
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- NCT04184973
- Testing
- CG-100 intraluminal bypass device, Stoma
- Where
- 10 sites in United States, Germany and 3 more
- Volunteers
- 250 people
- Sponsor
- Colospan Ltd.
Colorectal Cancer, Quality of Life
Peristomal Skin Complications and Quality of Life
This study is a single blind semi-experimental study. Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.
- Conditions
- Colorectal Cancer, Quality of Life, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT04375930
- Testing
- STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dokuz Eylul University
Stoma Site Leakage, Quality of Life
The Nordic Consensus Study
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.
- Conditions
- Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy
- Trial name
- NCS (NCT04763863)
- Testing
- Body Assessment Tool, Clinical usability evaluation of the Body Assessment Tool
- Where
- Denmark
- Volunteers
- 121 people
- Sponsor
- Coloplast A/S
Stoma Site Infection, Ileostomy - Stoma
Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy
Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy and colostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose…
- Conditions
- Stoma Site Infection, Ileostomy - Stoma, Colostomy Stoma
- Trial name
- PRIC (NCT04974931)
- Testing
- PREVENA Incision Management System
- Where
- Ireland
- Volunteers
- 50 people
- Sponsor
- St. James's Hospital, Ireland
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
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
This prospective, longitudinal observational cohort study aims to investigate the radiological incidence, anatomical progression, and impact on quality of life (QoL) of parastomal hernia (PH) in patients operated on for…
- Trial name
- NCT07909148
- Testing
- Routine Surveillance Computed Tomography (CT)
- Where
- Sweden
- Volunteers
- 135 people
- Sponsor
- Region Skane
Colostomy, Colorectal Neoplasm
A Randomized Trial on the Technical Aspects of Stoma Construction.
An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included.
- Conditions
- Colostomy, Colorectal Neoplasm, Diverticulitis
- Trial name
- NCT01694238
- Testing
- Cruciate incision, Circular incision, Mesh enforced cruciate incision
- Where
- Sweden
- Volunteers
- 209 people
- Sponsor
- Sahlgrenska University Hospital
Colorectal Cancer
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.
- Trial name
- NCT04449822
- Testing
- Emergency surgery, Colonic stenting
- Where
- Georgia
- Volunteers
- 40 people
- Sponsor
- Zaza Demetrashvili
Rectal Cancer
PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate. This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher…
- Trial name
- PROTECT (NCT04357171)
- Testing
- Low anterior resection with protective loop ileostomy, Low anterior resection with protective loop transverse colostomy
- Volunteers
- 202 people
- Sponsor
- Russian Society of Colorectal Surgeons
Ostomy - Ileostomy or Colostomy, Canser
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
The aim of this study is to examine the effect of ostomy care education-delivered to patients who have undergone ostomy surgery using the Teach-back method on patients' self-care ability, ostomy compliance, and anxiety levels.
- Conditions
- Ostomy - Ileostomy or Colostomy, Canser, Ileus, Intestinal Cancer
- Trial name
- NCT07788079
- Testing
- TEACH BACK METHOD
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people
- Sponsor
- Saglik Bilimleri Universitesi
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
Colorectal Cancer, Diverticulitis, Colonic
Colorectal Omics and OfCS Proteoglycans
This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.
- Conditions
- Colorectal Cancer, Diverticulitis, Colonic, Inflammatory Bowel Diseases, Stoma Colostomy
- Trial name
- COCO (NCT06287671)
- Testing
- Colorectal resection or stoma closure
- Where
- 2 sites in Denmark
- Volunteers
- 1,000 people
- Sponsor
- Claus Anders Bertelsen, PhD, MD
Diverticulum, Colon, Colorectal Neoplasms
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- NCT01880918
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- novoGI
Colorectal Cancer, Colorectal Neoplasms Malignant
Postoperative Effects of Different Enterostomy Approaches
Exploring the effect of protective ileostomy compared with transverse colostomy on the occurrence of complications, the occurrence of serious side effects of adjuvant chemotherapy and disease recurrence in patients with low…
- Conditions
- Colorectal Cancer, Colorectal Neoplasms Malignant, Intestinal Neoplasms, Malignant
- Trial name
- NCT05853094
- Testing
- Ileostomy, Transverse colostomy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
Colon Cancer
Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
The aim of this study is to determine whether chemotherapy prior to tumor removal (neoadjuvant chemotherapy), in patients undergoing treatment for colon cancer in occlusion (CCO), would improve the rate of patients able to…
- Trial name
- COnCERTO (NCT06107920)
- Testing
- Neoadjuvant chemotherapy
- Where
- 28 sites in France
- Volunteers
- 232 people
- Sponsor
- University Hospital, Rouen
Colorectal Cancer, Bladder Cancer
Connecting Audio and Radio Sensing Systems to Improve Care at Home
This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- AURA (NCT05344950)
- Testing
- Audio + Radio (AURA)
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center