This study investigates the impact of a goal directed nutritional support protocol on sarcopenia in oncological patients undergoing an esophagectomy and secondary the incidence of anastomotic leakage and pneumonia, surgical infection and lenght of…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sarcopenia (psoas and muscle area on L3 level) is the primary outcome. The
dofference in skeletal muscle index between the baseline CT-scan and the
routine CT-scan made before surgery will be the primary outcome
Secondary outcome
Secondary outcomes are anastomic leakage, pneumonia, infection, length of
hospital stay, readmission rate, survival
Background summary
Overall survival of patients with resectable esophageal cancer remains poor,
with 1 5-year survival of 23-47%. At time of diagnosis 50-85% of patients with
esophageal cancer are malnourished. This study investigates whether a goal
directed nutritional support protocol in oncological patients undergoing an
esophagectomy can reduce sarcopenia (muscle loss) and complications in these
patients.
Study objective
This study investigates the impact of a goal directed nutritional support
protocol on sarcopenia in oncological patients undergoing an esophagectomy and
secondary the incidence of anastomotic leakage and pneumonia, surgical
infection and lenght of stay, radmission rate and survival.
Study design
In this before/after multicenter study results of a goal directed nutritional
support wil be compared with nutritional care as usual. In het UMCG, 50
patients who had surgery in the past year, will be asked to take an additional
CT-scan one year after surgery. In the UMCG 50 patients will recieve the
intervention. In the ZGT hospital, first, 50 patients will be included with
care as usual. Next, 50 patients will recieve the intervention as well.
Intervention
The intervention is of a goal directed nutritional support, which consists of:
-The use of one nutritional case manager: one dietitian during the whole
treatment: during radiochemotherapy, hospitalizationa and postoperatively
-Monitoring of nutritional assessment oby PG-SGA (more awareness of
malnutrition)
-Weekly registration of food intake
-Measuring of energy-requirements by an indirect calorimeter (results in better
energy requirements than use of calculation formulas)
-Proactive use of sip-feedings, enteral tube feeding and parenteral nutrition
during the whole treatment period
Study burden and risks
Following the regular visits to the hospital, the patient will vist a nurse or
dietitian seven times in 15 months. A visit takes about 30 to 60 minutes extra.
The following additional procedures will take place:
-Measurement of the upper arm and hand grip strength
-Combined with ususal blood tests an additional blood sample taken to study the
nutritional status.
-The patient will be asked 3x to collect 24-hours urine to determine the muscle
mass
The patient is given a nutritional support from a dietitian
The patient will be asked to fill out two short questionnaires for each clinic
visit (five times). These questionnaire concern their (problems with) food
intake and their quality of life
-Daily energy requirements will be detemined twice at rest (of which 1x during
hospitalization). For this purpose, the amount of oxygen and carbion dioxide is
measured in the inhaled and exhaled air for 15 mintues while the patient is
lying on a bed. Meanwhile, by means of four patched on the patient's hand and
foot the muscle, fat and water content of the body will be determined
(bio-impedance analyses)
-The patient will be asked to wat a pedometer every two days before their visit
to the surgeon
-The patient receives an additional CT-scan wit a lower radiation dose. The
CT-scan will onlu be used to determine the muscle mass. It is not used for any
other (diagnostical) purpose.
-The small additional radiation exposure of the additional low dose CT-scan and
the extra time the research will take are neglible. This will not outweigh the
benefits of the potential increase of well-being and possibly better
nutritional status and longer survival of these patients. Most people are very
interested in their bodycomposition.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Patients >18 years that undergo an esophagectomy for cancer with cervial or intrathoracic anastomosis.
Written informed consent
Exclusion criteria
Inability to provide written consent or inability to fill out questionnaires
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 |
---|---|
CCMO | NL66893.042.18 |
Other | UMCG201600361 |