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Stoma Ileostomy clinical trials

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NCT ID: NCT06344078 Recruiting - Stoma Ileostomy Clinical Trials

Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).

SIGMA-D
Start date: January 1, 2024
Phase:
Study type: Observational

This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months.

NCT ID: NCT06152276 Recruiting - Colorectal Cancer Clinical Trials

SafeHeal Diverting Ileostomy Pivotal Study

SH-SOC23
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.

NCT ID: NCT05373888 Recruiting - Stoma Ileostomy Clinical Trials

Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients

Start date: April 1, 2022
Phase:
Study type: Observational

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 for Use (IFU). The data obtained during routine clinical use will be documented in electronic Case Report Forms (eCRF). The investigation will consist of an enrolment visit (Visit 1, or V1) and a final visit (Visit 2, or V2). The duration between the two visits is 14 (±3) days.

NCT ID: NCT04984161 Recruiting - Nurse's Role Clinical Trials

The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

This project; It is a quasi-experimental prospective study in a single group pre-test post-test order. No randomization will be made in the selection of the sample, and 30 nurses working in the Pediatric Surgery Clinic in hospitals in Izmir and meeting the inclusion criteria will be included in the study. The data of the study will be collected through the Nurse Descriptive Characteristics Questionnaire and the Pediatric Stoma Care Knowledge and Skills Questionnaire. Pre-training introductory characteristics and pediatric stoma care knowledge and skill level of all nurses participating in the study will be measured. After the measurement, the nurses participating in the study will be given training on pediatric stoma care. Immediately after the training and three months later, the pediatric stoma care knowledge and skill levels of the nurses participating in the study will be re-measured. The introductory characteristics of the nurses involved in the project will be given as number and percentage distributions. Comparisons between nurses' introductory characteristics and Stoma Knowledge and Skills Questionnaire before and after education; It will be evaluated by non-parametric or parametric appropriate test. Comparisons between nurses' Stoma Knowledge and Skills Questionnaire scores in the pre- and post-education period will be evaluated by non-parametric or parametric appropriate test in dependent groups. The statistical significance value of the project was determined as p≤0.005. It is planned that the results of the project will mediate an international article and statement in which the effect of stoma care education on the knowledge and skill level of pediatric surgery nurses is presented. As a result of the project, if it is determined that stoma care education has an effect on the knowledge and skill level of pediatric surgery nurses, it is predicted that the quality of care of children with stoma who receive care in other institutions and organizations can be increased and the comfort of the child can be increased.

NCT ID: NCT04763863 Recruiting - Quality of Life Clinical Trials

The Nordic Consensus Study

NCS
Start date: October 20, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04709445 Recruiting - Ulcerative Colitis Clinical Trials

Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

NCT ID: NCT04374890 Recruiting - Stoma Ileostomy Clinical Trials

Evaluation of a New Supporting Ostomy Product

Start date: May 2020
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.

NCT ID: NCT04202666 Recruiting - Stoma Ileostomy Clinical Trials

The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

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. How to choose suitable skin barrier is important.

NCT ID: NCT03424447 Recruiting - Ileostomy - Stoma Clinical Trials

Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Start date: November 20, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay