Research with human participants

Overview of medical research in the Netherlands

INTESTINAL INFLAMMATION IN PATIENTS WITH A STOMA ON THE ILEUM- a pilot study

Published:
Last updated:

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Ethical review
Approved WMO
Status
Will not start
Health condition type
Gastrointestinal inflammatory conditions
Study type
Observational invasive

ID

NL-OMON35630

Source

ToetsingOnline

Brief title

INTESTINAL INFLAMMATION - a pilot study

Condition

  • Gastrointestinal inflammatory conditions

Synonym

diversion enteritis

Research involving

Human

Sponsors and support

Primary sponsor :
Universiteit Maastricht
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
diversion enteritis, intestinal inflammation

Outcome measures

Primary outcome

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Secondary outcome

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Background summary

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Study objective

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Study design

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Study burden and risks

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Public
Universiteit Maastricht

Universiteitssingel 50
6200 MD Maastricht
Nederland
Scientific
Universiteit Maastricht

Universiteitssingel 50
6200 MD Maastricht
Nederland

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- Patients with a stoma on the ileum or transverse colon
- Stoma constructed at least 1 month before inclusion
- Age above 18 years
- Written informed consent

Exclusion criteria

- Inflammatory bowel disease (IBD)
- Covering stoma on small intestine
- Antibiotic treatment 1 month prior to endoscopy or surgery

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Will not start
Enrollment :
10
Type :
Anticipated

Approved WMO
Date :
Application type :
First submission
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL23566.068.08