Nutritional Management of Acute and Chronic Enterocutaneous Fistulae

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St Mark's Hospital Foundation
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00212420
First received: September 13, 2005
Last updated: September 21, 2007
Last verified: September 2007
  Purpose

To Investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutaneous fistula


Condition Intervention
Enterocutaneous Fistulae
Procedure: parenteral nutrition; enteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Management of Acute and Chronic Enterocutaneous Fistulae

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

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

Estimated Enrollment: 150
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212420

Contacts
Contact: David AJ Lloyd, MA, MRCP david.lloyd@nwlh.nhs.uk
Contact: Simon Gabe, MD simon.gabe@nwlh.nhs.uk

Locations
United Kingdom
St Mark's Hospital, North West London Hospitals NHS Trust Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Contact: Alan Warnes, PhD       alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova, MA       iva.hauptmannova@nwlh.nhs.uk   
Principal Investigator: David AJ Lloyd, MA MRCP         
Sponsors and Collaborators
North West London Hospitals NHS Trust
St Mark's Hospital Foundation
Investigators
Principal Investigator: David AJ Lloyd, MA, MRCP St Mark's Hospital, North West London NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00212420     History of Changes
Other Study ID Numbers: 04/Q0405/CEF106
Study First Received: September 13, 2005
Last Updated: September 21, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
fistula; enterocutaneous; nutrition;enteral; parenteral; TPN

Additional relevant MeSH terms:
Fistula
Intestinal Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 21, 2014