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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23654

Enrollment

268

Registered

2010-06-09

Start date

2010-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

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

Interventions

The objective of this trial is to compare the effectiveness of intracutaneously versus transcutaneously sutured ileostomy to reduce leakage, costs and to improve patients’quality of life. The transcut

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients who receive an end or loop ileostomy; 2. Age between 18 and 80 years; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Life expectancy of less than one year; 2. BMI > 35 or < 18; 3. Emergency surgery; 4. ASA IV; 5. Insufficient command of the Dutch language or cognitively unable to complete Dutch questionnaires.

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Quality of life, as measured by the Stoma-Qol; 2. Stoma-related morbidity; 3. Cost analysis (Stoma materials and outpatient visits).	—

Contacts

Public ContactM.F. Sier

Meibergdreef 9

mfsier@amc.nl+31 (0)6 42273862

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)