The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main clinical outcome parameter is postoperative ileus.
Secondary outcome
- Anastomotic leakage
- Aspiration pneumonia
- Gastric volumes preoperatively
- Length of functional recovery
- The local and systemic inflammatory response
- Surgical complications
- Length of stay
- Intestinal barrier function and local inflammation in the gut
- Need for additional surgical, radiological or endoscopic interventions
- Need for ICU admission and total length of ICU stay
- micriobiota in feces pre and postoperatively
- Quality of life (EQ-5D and EORTC-QLQ-C30 at baseline, after 3 and 6 months)
Background summary
Postoperative ileus and anastomotic leakage are complications associated with
short-term morbidity and mortality following colorectal surgery. Based on
experimental studies, we hypothesize that enriched enteral nutrition shortly
before, during and early after colorectal surgery reduces inflammation by
stimulation of the autonomic nervous system and thereby postoperative ileus
(POI) and anastomotic leakage.
Study objective
The main objective is to investigate the effects of perioperative nutrition on
postoperative ileus and anastomotic leakage in patients undergoing colorectal
surgery
Study design
A prospective double-blind randomized controlled trial
Intervention
Perioperative nutrition via a nasojejunal tube
Study burden and risks
Patients allocated in both groups receive a selfmigrating nasojejunal tube one
day before surgery. The position of the tube is checked via X-ray the same day.
Blood samples will be collected at several predefined moments in relation to
the moment of incision. Furthermore, gastric emptying will be assessed via
ultrasound as previously performed in another protocol in the Catharina
Hospital (SANICS trial M11-1102, CCMO NL25588.096.08). This intervention may
benefit the patient by reducing postoperative complications and enhancement of
recovery.
Peritoneal lavage is performed at the start of surgery and at the end of
surgery. Also gastric content is measured during surgery. It is expected that
these procedures will be no burden for the patient.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
- patients that undergo colorectal surgery with primary anastomosis
- written informed consent
- age above 18 years
Exclusion criteria
- use of medication that disrupts acetylcholine metabolism
- steroid use
- previous gastric or esophageal resection
- peritoneal metastases found during surgery
- pre-existent or creation of an ileostomy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02175979 |
| CCMO | NL45640.060.13 |
| OMON | NL-OMON20551 |