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Colostomy Stoma clinical trials

View clinical trials related to Colostomy Stoma.

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NCT ID: NCT04793009 Completed - Hernia Clinical Trials

Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection

Start date: January 1, 2013
Phase:
Study type: Observational

This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.

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: NCT04397783 Recruiting - Clinical trials for Colorectal Neoplasms

Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

LONGCROSS
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

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 ". DESIGN: Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio. POPULATION: Patients undergoing colorectal cancer surgery a definitive end colostomy. OBJECTIVES: The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery. Secondary objectives are: 1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery. 2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. 4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale). DESCRIPTION OF THE INTERVENTION: An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia. DURATION OF THE STUDY: The expected duration of the study is 3 years. PATIENT FOLLOW UP TIME: The planned follow-up time is 2 years. EXPECTED RECRUITMENT TIME: 12 months.

NCT ID: NCT04282473 Recruiting - Parastomal Hernia Clinical Trials

Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

RESEDAE
Start date: May 24, 2022
Phase:
Study type: Observational

This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

NCT ID: NCT04141566 Completed - Quality of Life Clinical Trials

Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma

Start date: January 1, 2018
Phase:
Study type: Observational

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 abdominoperineal resection (APR) for ultra low rectal cancer

NCT ID: NCT03770078 Completed - Ileostomy - Stoma Clinical Trials

Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

Start date: November 12, 2018
Phase: N/A
Study type: Interventional

The study investigates the performance of a new adhesive with regard to the skin condition

NCT ID: NCT03707392 Recruiting - Ileostomy - Stoma Clinical Trials

A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching

Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

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 and postoperative stoma care teaching video. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.

NCT ID: NCT03703661 Enrolling by invitation - Clinical trials for Surgical Site Infection

Needle-Aspirated Compression Dressing Following Ostomy Reversal

Start date: August 27, 2017
Phase: Phase 3
Study type: Interventional

Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections. This study studies the effect of a low cost needle-aspirated negative pressure compression dressing on rates of wound infection at prior ostomy site in patients undergoing ostomy reversal surgery.

NCT ID: NCT03516916 Enrolling by invitation - Quality of Life Clinical Trials

Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score

Start date: February 1, 2019
Phase:
Study type: Observational [Patient Registry]

The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life. As the oncological results have improved over the last decades the number of survivors from rectal cancer who have to adjust to a cancer free life in their own homes is increasing. To enable the identification of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7 items of stoma related factors with significant impact on HRQoL. The purpose of the present project is to perform an international validation of the CI-score and to demonstrate its applicability. The construct validity of the CI-score will be studied internationally on crosssectional cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey, Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the 5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ C30 questionnaire v3.0). The impact of the challenges related to having a stoma may vary with different demographic, socioeconomic and cultural factors. Supplementary data on stoma care, demographics and socioeconomic status will be gathered to study the impact of patient-related factors and cultural differences on HRQoL in rectal cancer survivors with an ostomy.

NCT ID: NCT03397901 Recruiting - Anemia Clinical Trials

Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study

Start date: July 20, 2018
Phase: N/A
Study type: Interventional

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. We proposed this prospective cohort study, to assess the efficacy and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe anemia, to provide higher-quality evidence of colostomy in these patients.