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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34429

Enrollment

300

Registered

2010-09-23

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

artificial opening of the small intestine ileostomy

Interventions

Stitching the ileostomy intracutaneously instead of transcutaneously

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All patients who receive an end or loop ileostomy - Age between 18 and 80 years - Written informed consent

Exclusion criteria

Exclusion criteria: - Life expectancy of less than one year - BMI > 35 or

Design outcomes

Primary

Measure	Time frame
Leakage of feces under the stoma plaque and peristomal dermatitis around the stitiches or due to leakage of feces	—

Secondary

Measure	Time frame
Quality of life, as measured by the Stoma-Qol Stoma-related morbidity Cost analysis (Stoma materials and outpatient visits)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)