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Patient Education for Ostomy Care

N/A

Recruiting

Led By Bruce W Robb, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who do NOT have any history of prior colostomy or ileostomy

Scheduled to undergo surgery at IU Health North Hospital that will result in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six weeks

Awards & highlights

Study Summary

This trial will compare two different methods of teaching people with ostomies how to care for their stomas.

Who is the study for?

This trial is for adults over 18 who are scheduled to have surgery at IU Health North Hospital resulting in a colostomy or ileostomy, without prior history of such procedures. They must be able to attend extra clinic visits for ostomy education and care, and not planning any urinary diversions.Check my eligibility

What is being tested?

The study compares standard ostomy site care with additional pre-operative and two-week post-operative education sessions. It aims to determine if more teaching improves patient outcomes after they've had an operation that results in an ostomy.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, there are no direct side effects from drugs; however, participants may experience varying levels of anxiety or comfort based on the amount of information provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had a colostomy or ileostomy.

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I am scheduled for surgery at IU Health North Hospital for a colostomy or ileostomy.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Life

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Two-week Post Operative EducationExperimental Treatment3 Interventions

In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.

Group II: Pre-Operative EducationExperimental Treatment2 Interventions

In addition to standard ostomy education, subjects will receive additional education pre-operatively.

Group III: StandardActive Control1 Intervention

Subjects will receive standard ostomy education.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard

2013

Completed Phase 4

~5340

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,996 Total Patients Enrolled

Bruce W Robb, MDPrincipal InvestigatorIndiana University, Department of Surgery

Media Library

Standard Clinical Trial Eligibility Overview. Trial Name: NCT02036268 — N/A

Ostomy Research Study Groups: Pre-Operative Education, Two-week Post Operative Education, Standard

Ostomy Clinical Trial 2023: Standard Highlights & Side Effects. Trial Name: NCT02036268 — N/A

Standard 2023 Treatment Timeline for Medical Study. Trial Name: NCT02036268 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are receiving treatment in this trial?

"Affirmative. The information available on clinicaltrials.gov states that this medical study is still recruiting participants, which it began to do since May 1st 2012 and was last updated February 19th 2019. This trial requires 75 volunteers from one specific location."

Answered by AI

Does this research initiative accept participants over 25 years of age?

"According to the specifications of this clinical trial, eligible participants must fall between 18 and 90 years old."

Answered by AI

Is this study recruiting any additional participants?

"According to data hosted on clinicaltrials.gov, this research is presently enrolling participants - its first posting was on May 1st 2012 and it was recently updated February 19th 2019."

Answered by AI

May I join in the experimental program?

"This clinical trial is seeking 75 participants with ostomies aged 18-90. To be eligible for enrolment, potential candidates must fulfil the following criteria: Being at least eighteen years of age during consenting., Scheduled to undergo surgery at IU Health North Hospital which will result in a temporary/permanent colostomy/ileostomy due to benign or malignant disease processes., Not having any pre-existing urostomy or other urinary diversion and not planning to have one as part of their surgical procedure., Willingly attending 2 additional clinic visits centred on teaching and care relating to stomas., Having no prior history of colost"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Different Levels of Patient Education for Care of Ostomy Site

Bruce W. Robb 2012. "Different Levels of Patient Education for Care of Ostomy Site". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02036268.

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