The primary objective of this clinical survey is to investigate the difference in morbidity and mortality after elective abdominal surgery for colon or rectal carcinoma in different age groups (55-75 years and older than 75 years).and to determine…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Protein and amino acid metabolism disorders NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infectious complications (fever, pneumonia, sepsis, bacteraemia, intrathoracic
or intra-abdominal infection, major wound infection, central-line infection,
urinary-tract infection); non-infectious complications as CV-complications
(infarct, cardiac failure, cerebrovascular accident, deep venous thrombosis,
hypotension and infarct), re-operation, transfusion-needed anemia, anastomotic
leakage and MOF; nutritional status by weight, BMI, Bioelectrical Impedance
Analysis (LBM, skeletal body mass, ECF, ICF, TBW) and metabolic status by and
amino acid profiles, CRP, albumin, glucose, insulin, fructosamine, HbA1c and
ADMA.
Secondary outcome
not applicable
Background summary
An increasing number of elderly patients are nowadays operated upon while still
little knowledge is gathered to determine risk factors that influence clinical
outcome. With increasing age, marked differences appear such as muscle loss
(sarcopenia, low fat free mass index) that compromise the ability to sustain
injury such as surgical trauma (Fujita S, J Nutr 2006; 136: 277, Volpi E, AJCN
2003; 78:250, Doherty T, J Appl Physiol 2003; 95 :1717) and are associated with
an increased length of hospital stay (Kyle UG, Clin nutr 2005; 24:133-142).
Morbidity rates, especially severe infectious and noninfectious complications,
of patients after major surgery, are significantly higher in malnourished
patients (Kuzu MA, World J of surg 2006; 30: 378-390).
Approximately one-third to one-half of hospitalized patients are malnourished
at the time of admission (McWhirter JP, BMJ 1994; 308945-948). Among
hospitalized elderly, nutritional status is even poorer. Protein-energy
malnutrition has been reported in up to 62% of hospitalized elderly patients
(Kagansky N, Am J Clin Nutr. 2005 Oct;82(4):784-91; quiz 913-4). With
increasing age the human body also changes with regards to lean body mass and
immunology (affected by undernutrition) (Lesourd B, Proc Nutr Soc. 2006
Aug;65(3):319-25), changes also attributing to increased vulnerability to
surgical trauma and these patients have more co-morbidity when presenting them
with an operable disease, such as arteriosclerosis, diabetes mellitus and other
degenerative diseases pointing at increased risks for poor clinical outcome1
(Bergeron E, Can J Surg 2005; 48:361).
Study objective
The primary objective of this clinical survey is to investigate the difference
in morbidity and mortality after elective abdominal surgery for colon or rectal
carcinoma in different age groups (55-75 years and older than 75 years).and to
determine age-related risk factors related to nutritional and metabolic
pre-operative status on postoperative outcome.
Study design
open, prospective, observational study in patients undergoing elective
abdominal surgery for colon or rectal carcinoma in different age groups
Study burden and risks
minimal burden as risks, no intervention is applied in this observational study
no direct benefit for this group of patients is anticipated
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
• Admission for elective abdominal surgery for colon or rectal carcinoma.
• Age: >55 years.
• Fit for elective surgery as defined by ASA score.
• Having obtained his/her informed consent
Exclusion criteria
Younger than 55 years
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 | NL15001.060.06 |