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Colostomy Stoma clinical trials

View clinical trials related to Colostomy Stoma.

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NCT ID: NCT06394115 Completed - Ileostomy - Stoma Clinical Trials

Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study

OUTFLOW
Start date: August 1, 2022
Phase:
Study type: Observational

The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.

NCT ID: NCT06320002 Recruiting - Surgery Clinical Trials

Communication Intervention for Fecal Ostomy Surgery

CI-oSurg
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention.

NCT ID: NCT06226753 Not yet recruiting - Anesthesia Clinical Trials

Impact of General Anesthesia v/s Spinal Anesthesia on ERAS Parameters in Intestinal Stoma Reversal

SPIGERAS
Start date: February 2024
Phase: N/A
Study type: Interventional

Randomized, Interventional ,Open labeled, Parallel Assignment and Superiority trial.

NCT ID: NCT05635188 Completed - Clinical trials for Surgical Procedure, Unspecified

Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection

Start date: January 2008
Phase:
Study type: Observational

This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).

NCT ID: NCT05466721 Completed - Colostomy Stoma Clinical Trials

Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

Start date: June 13, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05321134 Recruiting - Colo-rectal Cancer Clinical Trials

Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

Start date: April 28, 2022
Phase: N/A
Study type: Interventional

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

NCT ID: NCT05289765 Completed - Ileostomy - Stoma Clinical Trials

Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene

gAOVEstoma
Start date: February 22, 2022
Phase: N/A
Study type: Interventional

To evaluate the efficacy of the application of a neutral gel based on ecological extra virgin olive oil for peristomal skin hygiene in individuals with colostomy and ileostomy.

NCT ID: NCT05200416 Completed - Ileostomy - Stoma Clinical Trials

Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status. The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

NCT ID: NCT05163873 Completed - Quality of Life Clinical Trials

ExPECT: Extraperitoneal End Colostomy Trial

ExPECT
Start date: December 9, 2021
Phase: N/A
Study type: Interventional

A randomised controlled feasibility study to compare two surgery techniques in the formation of a permanent end colostomy; the trans-peritoneal(TP) technique - currently, the most commonly used technique and the investigational extra-peritoneal(EP) technique, which has been reported in small studies to reduce the risk of parastomal hernia . This feasibility study will primarily aim to determine the feasibility viability of progression to a full multi-centre trial and test study design acceptability for participants. Participants will be asked to consent to be randomised to either the TP or EP procedure during surgery. Following surgery, participants will be followed up to a maximum of 12 months and asked to complete quality of life questionnaires (EQ5D and Colostomy Impact Score). Participant data will also be accessed by research teams at site to collect data on stoma appliance use and complications.

NCT ID: NCT04974931 Not yet recruiting - Ileostomy - Stoma Clinical Trials

Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy

PRIC
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

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 significant financial ramifications. There have been comparative studies in the use of negative pressure wound therapy in reducing surgical site infections. PREVENA Incision Management System is a type of disposable, customizable and powered negative pressure system designed to help manage and protect surgical incisions and their surrounding environment. It is now commonly used as a surgical wound dressings in the setting of vascular surgeries, post-cesarean infections and colorectal resections. Our study is designed as a randomised controlled trial to examine if PREVERA therapy as a NPWT is more superior than conventional dressings in reducing the rate of surgical site infections.