Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients

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)

Study Overview

• Status: Completed
• Conditions: Digestive System Cancer

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Thailand
  • Bankok
    • Bangkok, Bankok, Thailand, 10400
      • Chairat Supsamutchai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery.

Description

Inclusion Criteria:

• All patients GI cancer
• Elective surgery

Exclusion Criteria:

• Lack of oncologic treatment information before surgery
• No history of recurrent cancer or more than one cancer disease
• Patients who have been diagnosed with Carcinomatosis peritonei during the operation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	The complication were collected according to Clavin-Dindo Classification	1 month
postoperative complications	The complication were collected according to Clavin-Dindo Classification	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative nutrition status	operative nutrition status assess by Nutrition Alert Form (NAF)	1 month
operative nutrition status	operative nutrition assess by Nutrition Alert Form (NAF)	3 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay	1 month

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Study Chair: Chairat Supsamutchai, MD, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Perioperative Nutritional Status; Surgical Outcome in Digestive System Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms
• Other Study ID Numbers: 2018/526

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No