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

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ClinicalTrials.gov Identifier: NCT03763526
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief 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)


Condition or disease
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

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Study Type : Observational
Estimated Enrollment : 196 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Length of hospital stay [ Time Frame: 1 month ]
    Length of hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763526


Contacts
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Contact: Chairat Supsamutchai, MD (66)0851156958 pogeneral2007@hotmail.com
Contact: Songpol Phosuwan, MD (66)0818755110 chocotong@hotmail.com

Locations
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Thailand
Chairat Supsamutchai Recruiting
Bangkok, Bankok, Thailand, 10400
Contact: Chairat Supsamutchai, MD    022011527 ext 245    pogeneral2007@hotmail.com   
Contact: Chumpon Wilasrusmee, MD    022011527 ext 145    chumpon.wil@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
Investigators
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Study Chair: Chairat Supsamutchai, MD Faculty of Medicine Ramathibodi Hospital, Mahidol University.

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03763526     History of Changes
Other Study ID Numbers: 2018/526
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Perioperative Nutritional Status
Surgical Outcome in Digestive System Cancer
Additional relevant MeSH terms:
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Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases