Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
Primary Purpose
Enterocutaneous Fistulae
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
parenteral nutrition; enteral nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Enterocutaneous Fistulae focused on measuring fistula; enterocutaneous; nutrition;enteral; parenteral; TPN
Eligibility Criteria
Inclusion Criteria: patients with an enterocutaneous fistula for > 14 days who have been referred to the Nutrition Team (or Pharmacy) for initiation of parenteral nutrition Exclusion Criteria: 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
Sites / Locations
- St Mark's Hospital, North West London Hospitals NHS TrustRecruiting
Outcomes
Primary Outcome Measures
To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00212420
First Posted
September 13, 2005
Last Updated
September 21, 2007
Sponsor
London North West Healthcare NHS Trust
Collaborators
St Mark's Hospital Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00212420
Brief Title
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
Official Title
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
London North West Healthcare NHS Trust
Collaborators
St Mark's Hospital Foundation
4. Oversight
5. Study Description
Brief Summary
To Investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutaneous fistula
Detailed Description
Enterocutaneous fistulae are abnormal connections between bowel and skin through which bowel contents pass. Their management present a considerable medical and surgical challenge. Since the 1970s the mainstray of treatment has been supportive with initiation of a "nil by mouth" regimen and intravenous (parenteral) nutrition with the aim of stabilising the patient and inducing gastrointestinal tract rest. There seems to have been an unquestioned benefit attributed to total parenteral nutrition (TPN) in the 1970s and 1980s which has carried through to the current day. This rigid approach to the management of enterocutaneous fistulae is almost universal and yet an extensive literature search suggests both mixed results from clinical trials and mixed opinions from experts in the field.
A large study published in the late 1970s (Souters et al. 1979) demonstrated that there was a 44% mortality in patients with an enterocutaneous fistula from 1946 to 1959 which fell to 15% between 1960 and 1970 with the introduction of improved parasurgical care; after 1970 no further decrease in mortality rate was observed despite the introduction of parenteral nutrition. It could therefore be argued that parenteral nutrition offers no real additional benefit to these patients. Surprisingly there is no information in the literature comparing enteral nutrition with parenteral nutrition in patients with an enterocutaneous fistula.
Enter nutrition is more physiological, is associated with fewer complications and is cheaper when compared to parenteral nutrition. If parenteral nutrition were shown to offer no benefit with regards to fistula closure in patients with enterocutaneous fistula then enteral feeding would be the nutritional modality of choice. This would constitute a major shift in the current management of such patients.
Recent research has shown that the supply of nutrients to the lining of the gastrointestinal tract can have a significant effect on the growth of the cells lining the gut and on the motility as a whole. Many of these effects are mediated by intestinal growth factors such and glucagon-like peptide-2 (GLP-2) and gut hormones such as cholecystokinin (CCK) and peptide YY (YYY. Although no studies have been performed looking at the levels of growth factors and gut hormones in patients with enterocutaneous fistulae, it seems theoretically likely that the route of nutrition in these patients will have an effect on the levels of these intestinal growth factors and gut hormones. This in turn may have effect on fistula healing and fistula output. Modulation of the levels of these growth factors and gut hormones may provide new therapeutic options in the future management of enterocutaneous fistulae.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterocutaneous Fistulae
Keywords
fistula; enterocutaneous; nutrition;enteral; parenteral; TPN
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
parenteral nutrition; enteral nutrition
Primary Outcome Measure Information:
Title
To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with an enterocutaneous fistula for > 14 days who have been referred to the Nutrition Team (or Pharmacy) for initiation of parenteral nutrition
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David AJ Lloyd, MA, MRCP
Email
david.lloyd@nwlh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Gabe, MD
Email
simon.gabe@nwlh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David AJ Lloyd, MA, MRCP
Organizational Affiliation
St Mark's Hospital, North West London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mark's Hospital, North West London Hospitals NHS Trust
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Warnes, PhD
Email
alan.warnes@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Iva Hauptmannova, MA
Email
iva.hauptmannova@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
David AJ Lloyd, MA MRCP
12. IPD Sharing Statement
Learn more about this trial
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
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