Does peri-operative enteral nutrition and immunonutrition alter immunological response to surgery, improve blood supply to the gut and improve clinical outcome of patients undergoing restorative proctocolectomy?
| ISRCTN | ISRCTN12388805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12388805 |
| Secondary identifying numbers | N0515088426 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Sarah Mills
Scientific
Scientific
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow, Middlesex
HA1 3UJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Does peri-operative enteral nutrition and immunonutrition alter immunological response to surgery, improve blood supply to the gut and improve clinical outcome of patients undergoing restorative proctocolectomy? |
| Study objectives | Improved peri-operative enteral nutrition and immunonutrition beneficially alter the patient's immunological response to the insult of major pelvic surgery. Restorative proctocolectomy for ulcerative colitis is undertaken for two reasons, either because of the failure of medical management to control symptoms and dependence on immune suppressants or the risk of developing adenocarcinoma following many years of ulcerative colitis. Patients electing to undergo restorative proctocolectomy have therefore been suffering from a chronic disease that effects their nutritional and immune state, leading to higher rates of post operative complications including sepsis, leading to a significant increase in morbidity and hospital stay. Unfortunately, around 10% of ileoanal pouches fail and require excision the majority of these in the first 2 years due to pelvic sepsis. This trial will compare surrogate markers of immune modulation and clinical complications in fed and unfed groups to assess the benefit of peri-operative enteral nutrition. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Restorative proctocolectomy |
| Intervention | Patients will be assigned to one of three groups: Group 1 will receive normal pre-operative and post-operative care with no supplemental nutrition. Group 2 will receive one week pre-operative supplemental enteral nutrition isocalorific and isonitrogenous to IMPACT to provide 25 Kcal/kg/day. Group 3 will receive one week pre-operative supplemental enteral nutrition with IMPACT to provide 25 Kcal/kg/day. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Peripheral blood leukocyte subsets will be tested for intracellular pro-inflammatory cytokines InterLeukin-6 (IL-6), InterLeukin-2 (IL-2) and anti-inflammatory cytokine InterLeukin-10 (IL-10) using the technique of Carrock Sewell et al 1997. Phagocyte activity of both granulocytes and monocytes will be tested directly using fluroescein labeled opsonised bacteria. Blood will be taken prior to feeding, preoperatively, intraoperatively and on postoperative days three and seven. At laparotomy a biopsy of small bowel mucosa will be taken to assess leukocyte subsets for intracellular pro-inflammatory cytokines IL-6, IL-2 and anti-inflammatory cytokine IL-10. Phagocyte activity of both granulocytes will be tested directly using fluorescein labeled opsonised bacteria. Two further biopsies will be taken on days three and seven postoperatively for correlation with the peripheral blood immunology. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2000 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 30 patients aged between 18-65 years old |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
North West London Hospitals NHS Trust
Harrow, Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
North West London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/09/2016: No publications found, verifying study status with principal investigator.
