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ID
Source
Brief title
Health condition
Nutrition, Rectal Surgery, Ileus, Infection, Length of hospital stay, Amino acids, Glucose, Immune function
Voeding, Rectum chirurgie, Ileus, Infectie, Duur van opname, Aminozuren, Glucose, Immuunsysteem
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
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).
Study design
V-1= Pre-operatively (one day before surgery)
V1= Postoperatively Day 1
V2= Postoperatively Day 5
V3= Day of discharge
Intervention
1- Enteral nutrition starting 8 hours postoperatively
2- Parenteral nutrition starting 8 hours postoperatively
P.G. Boelens
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
+31 (0)40 2399111
drboelens@hotmail.com
P.G. Boelens
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
+31 (0)40 2399111
drboelens@hotmail.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL678 |
| NTR-old | NTR1523 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |