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


- candidate number8129
- NTR NumberNTR2369
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2010
- Secondary IDs10/150 METC AMC
- Public TitleIntracutaneously versus transcutaneously sutured ileostomy: A randomized multicenter trial (ISI trial).
- Scientific TitleIntracutaneously versus transcutaneously sutured ileostomy: A randomized multicenter trial (ISI trial).
- ACRONYMISI trial
- hypothesisAn intracutaneously sutured ileostomy may be more effective than a transcutaneously sutured ileostomy to reduce peristomal dermatitis, leakage and costs and to improve quality of life of patients with an ileostomy.
- Healt Condition(s) or Problem(s) studiedAttachment, Ileostomy, Leakage, Feces, Skin irritation
- Inclusion criteria1. All patients who receive an end or loop ileostomy;
2. Age between 18 and 80 years;
3. Written informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate31-dec-2012
- Target number of participants268
- InterventionsThe 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 transcutaneous character of the stitches can cause skin irritation around the stitches, it might cause leakage of feces under the stoma plaque thereby increasing skin irritation and early release of stoma plaque. This will also increase costs, because the stoma materials will have to be changed more often.

The trial is designed as a 10-center randomized clinical trial including all patients who receive an ileostomy. Patients will be randomized to receive either an intracutaneously or transcutaneously sutured ileostomy.
- Primary outcomeLeakage of feces under the stoma plaque and peristomal dermatitis around the stitches or due to leakage of feces.
- Secondary outcome1. Quality of life, as measured by the Stoma-Qol;
2. Stoma-related morbidity;
3. Cost analysis (Stoma materials and outpatient visits).
- Timepoints1. Skin irritation and stoma related morbidity: At one week, two weeks, one month, two and three months;
2. !uality of life: One month and three months;
3. Cost analysis with a diary up to three months.
- Trial web sitewww.isitrial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.F. Sier
- CONTACT for SCIENTIFIC QUERIES M.F. Sier
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dansac, Coloplast, Convatec
- PublicationsN/A
- Brief summaryIn colorectal surgery, an ileostomy is often constructed to protect temporarily a distal colonic anastomosis. Even though the construction of an ileostomy is a procedure commonly performed by both general and colorectal surgeons, it has a high morbidity rate. In several studies the complication rate varied between 21 and 60 per cent. Thus, receiving an ileostomy has been associated with a decreased quality of life and a reduced physical and psycological well being.
Enterostomal therapists see many stoma-related complications, for example leakage of feces under the stoma plaque. This in turn can cause peristomal dermatitis, granuloma and fungal infections.
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 transcutaneous character of the stitches can cause skin irritation around the stitches, it might cause leakage of feces under the stoma plaque thereby increasing skin irritation and early release of stoma plaque. This will also increase costs, because the stoma materials will have to be changed more often.
The trial is designed as a 10-center randomized clinical trial including all patients who receive an ileostomy. Patients will be randomized to receive either an intracutaneously or transcutaneously sutured ileostomy. Primary outcomes are leakage, skin irritation, costs and the patients’ quality of life.
In order to detect an effect size of 0.05 at a 5% two-sided significance level with a power of 80%, a minimum sample size of 134 patients per treatment group is required. Patients will be included from September 2010 until March 2012, with a minimum follow-up duration of three months.
- Main changes (audit trail)
- RECORD9-jun-2010 - 1-okt-2014


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