Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03763526 |
| Other study ID # |
2018/526 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2018 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Mahidol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Malnutrition is a common problem in cancer patients. It negatively influences patients'
prognosis and quality of life. In gastrointestinal patients, it is also caused by insufficient
food intake due to dysphagia, lack of appetite, nausea, vomiting, impaired digestion and
absorption.
Furthermore, influence of prior oncologic treatment (surgery, chemotherapy, and
radiotherapy), have been associated with prolonged hospital stay, more postoperative
complications and low survival outcome1-4. So, the proper assessment of nutrition status to
detect perioperative malnutrition may allow appropriate nutritional therapy and improve
survival5.
However, the important factor which prolongs survival rate is good preoperative nutrition
status because it effects the postoperative nutrition outcome. The objective of this study is
to correlate the association between pre- and postoperative nutrition status and surgical
outcomes.
The Nutrition Alert Form (NAF) is a clinical tool for determining nutritional status. The NAF
was modified from Subjective Global Assessment (SGA)6, and it is easy to use and does not
require nutritional expertise based on laboratory and physical examination. Therefore, the
NAF has been used extensively for screening of malnutrition in hospitalized Thai patients and
it can classify the nutritional status into three groups : NAF-A (Normal-Mild malnutrition),
NAF-B (Moderate malnutrition), NAF-C (Severe malnutrition)
Description:
Primary Questions
- What is the relationship between the preoperative nutrition status and the postoperative
nutrition status in gastrointestinal cancer patients ?
Secondary Questions
- What is the relationship between malnutrition during preoperative and postoperative stages,
compared with postoperative complications?
OBJECTIVE :
The objective of this study is to study the association between pre- and postoperative
nutrition status compared with postoperative complications and surgical outcome. The results
of this study may affect future nutrition practices and encourage different behaviors in
gastrointestinal cancer patients who prepare to undergo surgery.
Sample size is calculated by n=(z_(1-α/2)^2 p(1-p))/d^2
Proportion (p) = 0.80, Error (d) = 0.064 Alpha (α) = 0.05, Z(0.975) = 1.959964 Power = 0.80
Sample size (n) = 178 Include drop out 10 % = 196 patients
Patients:
For 196 gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who
underwent scheduled surgery. Every patient underwent nutritional assessment by NAF before
surgery and (1 & 3 months) after surgery at in the Department of Surgery, Ramathibodi
Hospital and Buriram Hospital from 20 November 2018. Patients with incomplete documents were
excluded from this study.
DATA COLLECTION AND DATA ANALYSIS:
- Pre-operative nutrition status assess by NAF
- Post-operative nutrition status at 1 month and 3 months assess by NAF
- All postoperative complications were collected according to Clavin-Dindo Classification8
- All case were included in this study, following TNM staging and others pathologic
parameters :
- Cancer type - Tumor grading
- Lymph node metastasis - Tumor depth
