Colostomy Stoma Clinical Trial
Official title:
HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care. The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01995357 -
The Influence of Baseplate Adhesive on the Degree of Leakage
|
N/A | |
| Recruiting |
NCT04763863 -
The Nordic Consensus Study
|
||
| Completed |
NCT02974634 -
Ostomy Telehealth For Cancer Survivors
|
N/A | |
| Completed |
NCT03770078 -
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
|
N/A | |
| Not yet recruiting |
NCT04974931 -
Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy
|
N/A | |
| Recruiting |
NCT04282473 -
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
|
||
| Recruiting |
NCT06320002 -
Communication Intervention for Fecal Ostomy Surgery
|
N/A | |
| Completed |
NCT02544061 -
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
|
Phase 2 | |
| Completed |
NCT03108105 -
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
|
N/A | |
| Recruiting |
NCT03397901 -
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
|
N/A | |
| Recruiting |
NCT03707392 -
A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching
|
Phase 3 | |
| Completed |
NCT05635188 -
Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection
|
||
| Completed |
NCT05200416 -
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
|
N/A | |
| Completed |
NCT04141566 -
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
|
||
| Completed |
NCT04793009 -
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection
|
||
| Completed |
NCT05289765 -
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
|
N/A | |
| Not yet recruiting |
NCT06226753 -
Impact of General Anesthesia v/s Spinal Anesthesia on ERAS Parameters in Intestinal Stoma Reversal
|
N/A | |
| Enrolling by invitation |
NCT03516916 -
Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score
|
||
| Completed |
NCT05163873 -
ExPECT: Extraperitoneal End Colostomy Trial
|
N/A | |
| Enrolling by invitation |
NCT03703661 -
Needle-Aspirated Compression Dressing Following Ostomy Reversal
|
Phase 3 |