Enterocutaneous FistulaeNCT00212420
Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
A study testing parenteral nutrition; enteral nutrition in people with Enterocutaneous Fistulae, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
To Investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutaneous fistula Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterocutaneous Fistulae
- What is being tested?
- parenteral nutrition; enteral nutrition
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2004to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an enterocutaneous fistula for > 14 days who have been referred to the Nutrition Team (or Pharmacy) for initiation of parenteral nutrition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
David AJ Lloyd, MA, MRCP contact
Simon Gabe, MD contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Mark's Hospital, North West London Hospitals NHS Trust
Harrow, Middlesex, HA1 3UJ
Alan Warnes, PhD, alan.warnes@nwlh.nhs.uk
Iva Hauptmannova, MA, iva.hauptmannova@nwlh.nhs.uk
About this study
To Investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutaneous fistula
Read the 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.
- Conditions
- Enterocutaneous Fistulae
- Being tested
- parenteral nutrition; enteral nutrition
- Keywords
- fistula; enterocutaneous; nutrition;enteral; parenteral; TPN
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parenteral nutrition; enteral nutritionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterocutaneous FistulaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St Mark's Hospital Foundation
- Investigators
- David AJ Lloyd, MA, MRCP, Principal investigator, St Mark's Hospital, North West London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212420
- Sponsor's protocol ID
- 04/Q0405/CEF106
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2005
- Last updated
- 24 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Management of Acute and Chronic Enterocutaneous Fistulae
- ClinicalTrials.gov ID
- NCT00212420
- Acronym / sponsor ID
- 04/Q0405/CEF106
- Conditions
- Enterocutaneous Fistulae
- Keywords
- fistula; enterocutaneous; nutrition;enteral; parenteral; TPN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- St Mark's Hospital Foundation
- Study start
- Dec 2004
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with an enterocutaneous fistula for > 14 days who have been referred to the Nutrition Team (or Pharmacy) for initiation of parenteral nutrition
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parenteral nutrition; enteral nutrition | Procedure or surgery | – |
Primary outcome
To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula
1 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David AJ Lloyd, MA, MRCP contact
Simon Gabe, MD contact
David AJ Lloyd, MA, MRCP principal investigator
St Mark's Hospital, North West London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parenteral nutrition; enteral nutrition in people with Enterocutaneous Fistulae, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David AJ Lloyd, MA, MRCP (david.lloyd@nwlh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate whether different routes of nutrition affect the probability of fistula closure in patients with an enterocutanous fistula. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.