What is the mechanism of action of this treatment?

Common treatments for ileostomy include the use of ostomy belts, which provide support and security to the ostomy appliance. The primary mechanism of action for ostomy belts is to stabilize the ostomy bag, reducing the risk of leaks and skin irritation by keeping the appliance securely in place. This is crucial for ileostomy patients as it enhances their comfort, mobility, and confidence, thereby improving their overall quality of life. Additionally, the support from the belt can help prevent hernias around the stoma site, a common complication for ileostomy patients.

What side effects are associated with this type of intervention?

Common treatments for ileostomy include the use of ostomy belts, which provide support and security to the ostomy appliance. Known side effects of using ostomy belts can include skin irritation, discomfort, and pressure sores due to prolonged wear. Additionally, improper fitting can lead to leakage and reduced effectiveness of the ostomy appliance. Other treatments for ileostomy, such as stoma care products and dietary adjustments, may also have side effects like skin reactions and nutritional deficiencies.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of ileostomy itself. However, various medical devices, such as ostomy belts, are commonly used to provide support and security to the ostomy appliance. These belts help to stabilize the ostomy pouch, reduce the risk of leaks, and improve the quality of life for patients with an ileostomy. While the FDA does regulate medical devices, specific approvals for ostomy belts are not typically highlighted in the same way as drug approvals.

What other types of research exist?

Promising alternatives to the Ostomy Belt for ileostomy patients include: 1) Advanced adhesive technologies in ostomy appliances that provide better skin protection and longer wear times. 2) Customizable ostomy systems that offer a tailored fit for individual body contours. 3) Integrated sensor technology in ostomy bags to monitor output and detect leaks, enhancing security and reducing the need for additional support. 4) Lightweight, breathable support garments designed specifically for ostomy patients, offering discreet support without the bulk of traditional belts.

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Ostomy Belt for Improved Quality of Life in Ostomy Patients

N/A

Waitlist Available

Led By Vanessa Hui, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

18 - 70 years old

Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt

Must not have

Patients without stoma or unwilling to wear ostomy belt

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 weeks, baseline to 8 weeks post ostomy belt use

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether wearing a special belt can make life better for people who have undergone certain surgeries. The belt helps keep medical equipment secure and comfortable, which might help these patients feel more at ease and confident.

Who is the study for?

This trial is for patients aged 18-70 with a stoma from the University of Miami Hospital who are willing to try an ostomy belt. Participants must be able to give informed consent. Those without a stoma or unwilling to wear the belt, or have conditions that may interfere with the study cannot join.

What is being tested?

The study aims to determine if wearing an ostomy belt can enhance life quality for people with colostomies and ileostomies. It involves using the belt as part of their daily management routine.

What are the potential side effects?

While not explicitly mentioned, potential side effects might include discomfort, skin irritation, or mobility issues due to wearing the ostomy belt.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 70 years old.

Select...

I am a patient at University of Miami Hospital with a stoma and open to trying an ostomy belt.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a stoma or I refuse to wear an ostomy belt.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 weeks, baseline to 8 weeks post ostomy belt use

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 weeks, baseline to 8 weeks post ostomy belt use

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks, baseline to 8 weeks post ostomy belt use for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in quality of life as measured by SQOLS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ostomy belt groupExperimental Treatment1 Intervention

Participants in this group will receive ostomy belts for eight weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ostomy belt

2021

N/A

~40

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ileostomy include the use of ostomy belts, which provide support and security to the ostomy appliance. The primary mechanism of action for ostomy belts is to stabilize the ostomy bag, reducing the risk of leaks and skin irritation by keeping the appliance securely in place. This is crucial for ileostomy patients as it enhances their comfort, mobility, and confidence, thereby improving their overall quality of life. Additionally, the support from the belt can help prevent hernias around the stoma site, a common complication for ileostomy patients.

[A study of the value of colonic stenting as a bridge to elective surgery for the management of acute left-sided malignant colonic obstruction: the STENT-IN 2 study].