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 |
| Protocol serial number | N0515088426 |
| Sponsor | Department of Health (UK) |
| Funder | North West London Hospitals NHS Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow, Middlesex
HA1 3UJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/09/2016: No publications found, verifying study status with principal investigator.
