Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212420
Status:
UNKNOWN
Last Update Posted:
2007-09-24
First Post:
2005-09-13
Brief Title:
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None