Intracutaneously versus transcutaneously sutured ileostomy: A randomized multicenter trial (ISI trial).

Recruiting

• Conditions: patients requiring an ileostomy for malignant or infectious diseases of the intestinal tract.ileostomy, leakage, feces, skin irritation, stitches, sutures

• Registration Number: NL-OMON23654
• Lead Sponsor: AMC

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 268

Inclusion Criteria

1. All patients who receive an end or loop ileostomy;

2. Age between 18 and 80 years;

Exclusion Criteria

1. Life expectancy of less than one year;

2. BMI > 35 or < 18;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eakage of feces under the stoma plaque and peristomal dermatitis around the stitches or due to leakage of feces.

Secondary Outcome Measures

Name	Time	Method
1. Quality of life, as measured by the Stoma-Qol;<br /><br>2. Stoma-related morbidity;<br /><br>3. Cost analysis (Stoma materials and outpatient visits).<br>