The main objective of this clinical survey is to improve the nutritional status of patients undergoing major rectal surgery, thereby aiming to reduce postoperative ileus using the Bengmark a self-migrating nasojejunal tube and early enteral…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative ileus (duration in days)
Secondary outcome
Nutritional status will be measured using weight and bio-impendence
measurements (Body stat).
Complications
Lenght of hospitalisation
Amino acid profiles
Glucose metabolism: bij glucose, insuline and HbA1c
Background summary
Nutritional problems are common in hospitalized surgical patients, high
percentages of patients undergoing colorectal surgery become more malnourished
while hospitalized. Patients with malnutrition tend to stay longer in the
hospital with increased costs and more infectious complications.
Numerous studies show that early enteral nutrition leads to better clinical
outcome . Unfortunately no solid evidence until now has established clear
evidence based on nutritional guidelines for this specific group of patients.
Study objective
The main objective of this clinical survey is to improve the nutritional status
of patients undergoing major rectal surgery, thereby aiming to reduce
postoperative ileus using the Bengmark a self-migrating nasojejunal tube and
early enteral nutritional strategies.
Study design
Open, randomized study, Catharina hospital, Eindhoven
Group 1: Oral challenge (conventional nutritional regime)
Group 2: early enteral nutrition starting 8 hours postoperatively, the same day
as
surgery.
Group 3: Late enteral nutrition starting 16 hours postoperatively, the morning
after surgery.
Group 2 and 3 will receive early nutrition via naso-jejunal tube (Bengmark) to
overcome the delayed gastric motility and will be compared with group 1.
There will be 3 research visits, weight and nutritional state will be measured
at day of admission, day after surgery and one week after surgery.
At these days also (extra) blood will be taken (total of 15 cc) and the BIA
measurements will be done. Thereby eventually clinical complications and length
of hospitalization will be reported.
BIA measuring is an easy and totaly not invasive measurement. While patients
are lying down, 4 electrodes are placed on the wrists and ankles. A little
electrical pulse (which is not noticeable) will be send through the body. The
impedance analyser calculates the composition of fluid in extracellular,
intracellular space, muscle and fat tissue by using the bodie's resistances.
Study burden and risks
1. patients (group 2 and 3) will receive a naso-jejunal tube which is
characterized by minimal complications and good patient compliance. Some
adverse effects such as nausea, vomiting, diarrhea, cramps and irritation of
the nose, throat, are known.
2. The location of the tube will be checked during surgery and there will not
be started with feeding untill it is sure that the tube location is correct.
And only when the patient is stable (MAP>60mmHg, gastric retention<100ml/h)
3. 3 times extra blood will be taken in total 15 cc, weight and nutritional
status will be measured as described above
4. some time after the end of the study, the investigators can contact the
patient , to follow up the longterm outcome
Michelangelolaan 2
5623 EJ Eindhoven
NL
Michelangelolaan 2
5623 EJ Eindhoven
NL
Listed location countries
Age
Inclusion criteria
Elective surgery
colorectal surgery by cancer
IORT
informed consent
Exclusion criteria
emergency rectal surgery
synchroneous partial liver resection or pulmonary resection
esophageal varices or GI bleeding
Design
Recruitment
Medical products/devices used
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 |
---|---|
CCMO | NL13927.060.06 |