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NCT Number: NCT03763526

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)

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Key information

Conditions

Digestive System Cancer Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. postoperative complications

    Time frame: 1 month

    The complication were collected according to Clavin-Dindo Classification

  2. postoperative complications

    Time frame: 3 month

    The complication were collected according to Clavin-Dindo Classification

Secondary outcomes

  1. operative nutrition status

    Time frame: 1 month

    operative nutrition status assess by Nutrition Alert Form (NAF)

  2. operative nutrition status

    Time frame: 3 month

    operative nutrition assess by Nutrition Alert Form (NAF)

Other outcomes

  1. Length of hospital stay

    Time frame: 1 month

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2018
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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