Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
1 other identifier
interventional
150
1 country
1
Brief Summary
To Investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutaneous fistula
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedSeptember 24, 2007
September 1, 2007
September 13, 2005
September 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula
Secondary Outcomes (1)
investigating if different routes of nutrition affect fistula output, complication rates, overall nutrition and quality of life in patients with an enterocutaneous fistula. To measure the levels of intestinal growth factors and gut hormones in patients
Interventions
Eligibility Criteria
You may qualify if:
- patients with an enterocutaneous fistula for \> 14 days who have been referred to the Nutrition Team (or Pharmacy) for initiation of parenteral nutrition
You may not qualify if:
- generalised peritonitis or systemic sepsis (SIRS)
- immediate need for surgery or radiological drainage procedures
- other contraindicators to either enteral or parenteral feeding
- age \< 18 years old
- lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Mark's Hospital, North West London Hospitals NHS Trust
Harrow, Middlesex, HA1 3UJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David AJ Lloyd, MA, MRCP
St Mark's Hospital, North West London NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
December 1, 2004
Last Updated
September 24, 2007
Record last verified: 2007-09