|- candidate number||4337|
|- NTR Number||NTR1523|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-nov-2008|
|- Secondary IDs|| |
|- Public Title||Early Total Parenteral versus Enteral Nutrition to Reduce Postoperative Ileus after Major Rectal Surgery.|
|- Scientific Title||Early Total Parenteral versus Enteral Nutrition to Reduce Postoperative Ileus after Major Rectal Surgery.|
|- hypothesis||1- Our hypothesis is that the incidence of POI will decrease more in Group 1 (receiving enteral nutrition) than in group 2 (receiving parenteral nutrition).
2- Group 1 (receiving enteral nutrition) will have more days of vomiting in comparison to group 2 (receiving parenteral nutrition).
3- Early enteral nutrition (group 1) will have a shorter hospital length of stay in comparison to group 2.
4- Patients from group 1 (receiving enteral nutrition) will return to a normal diet sooner as compared with other group 2 (receiving parenteral nutrition).
|- Healt Condition(s) or Problem(s) studied||Nutrition, Rectal dissection, Parenteral nutrition, Enteral nutrition, Ileus|
|- Inclusion criteria||1. Patients who will undergo elective major rectal surgery such as low anterior resection or abdominal perineal resection with or without intra-operative radiotherapy (IORT) for primary or recurrent disease.
2. Fit for elective surgery as defined by ASA score 1 to 3. (Whereby ASA 1 corresponds to a healthy patient. ASA 2 corresponds to a patient with mild, controlled, functionally non-limiting systemic disease and ASA 3 corresponds to a patient with severe or poorly controlled systemic disease that is functionally limiting).
3. Having obtained his/her informed consent.
|- Exclusion criteria||1. Patients undergoing an emergency rectal operation. |
2. Patients undergoing synchronous partial liver or pulmonary resection.
3. Esophageal varices or known with gastric or esophageal bleeding.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-jan-2009|
|- planned closingdate||5-jan-2010|
|- Target number of participants||60|
|- Interventions||1- Enteral nutrition starting 8 hours postoperatively|
2- Parenteral nutrition starting 8 hours postoperatively
|- Primary outcome||- Postoperative Ileus|
|- Secondary outcome||- Nutritional status|
- Complications (infection, diarrhea, vomiting, high gastric residuals)
- Length of hospital stay
- Amino acids profile
- Glucose metabolism
- Routine blood measurements
- Acute Phase Response
|- Timepoints||V-1= Pre-operatively (one day before surgery)|
V1= Postoperatively Day 1
V2= Postoperatively Day 5
V3= Day of discharge
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.G. Boelens|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.G. Boelens|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Nutricia Nederland B.V.|
|- Brief summary||The main objective of this clinical study is to reduce postoperative ileus by early enteral nutrition as compared to early parenteral strategies in patients undergoing rectal surgery. Comparing different early strategies of artificial nutrition in combination with standard care will generate valuable information about the incidence of ileus, infectious complications and hospital length of stay in this population. |
|- Main changes (audit trail)|
|- RECORD||5-nov-2008 - 31-okt-2011|