Clinical Trial: Nutritional Management of Acute and Chronic Enterocutaneous Fistulae

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Nutritional Management of Acute and Chronic Enterocutaneous Fistulae

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

Detailed Summary:

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.

Sponsor: London North West Healthcare NHS Trust

Current Primary Outcome: To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula

Original Primary Outcome: Same as current

Current Secondary Outcome: 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

Original Secondary Outcome: Same as current

Information By: London North West Healthcare NHS Trust

Dates:
Date Received: September 13, 2005
Date Started: December 2004
Date Completion:
Last Updated: September 21, 2007
Last Verified: September 2007