<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03763526</url>
  </required_header>
  <id_info>
    <org_study_id>2018/526</org_study_id>
    <nct_id>NCT03763526</nct_id>
  </id_info>
  <brief_title>Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients</brief_title>
  <official_title>Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnutrition is a common problem in cancer patients. It negatively inﬂuences patients'&#xD;
      prognosis and quality of life. In gastrointestinal patients, it is also caused by insufﬁcient&#xD;
      food intake due to dysphagia, lack of appetite, nausea, vomiting, impaired digestion and&#xD;
      absorption.&#xD;
&#xD;
      Furthermore, influence of prior oncologic treatment (surgery, chemotherapy, and&#xD;
      radiotherapy), have been associated with prolonged hospital stay, more postoperative&#xD;
      complications and low survival outcome1-4. So, the proper assessment of nutrition status to&#xD;
      detect perioperative malnutrition may allow appropriate nutritional therapy and improve&#xD;
      survival5.&#xD;
&#xD;
      However, the important factor which prolongs survival rate is good preoperative nutrition&#xD;
      status because it effects the postoperative nutrition outcome. The objective of this study is&#xD;
      to correlate the association between pre- and postoperative nutrition status and surgical&#xD;
      outcomes.&#xD;
&#xD;
      The Nutrition Alert Form (NAF) is a clinical tool for determining nutritional status. The NAF&#xD;
      was modified from Subjective Global Assessment (SGA)6, and it is easy to use and does not&#xD;
      require nutritional expertise based on laboratory and physical examination. Therefore, the&#xD;
      NAF has been used extensively for screening of malnutrition in hospitalized Thai patients and&#xD;
      it can classify the nutritional status into three groups : NAF-A (Normal-Mild malnutrition),&#xD;
      NAF-B (Moderate malnutrition), NAF-C (Severe malnutrition)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Questions&#xD;
&#xD;
      - What is the relationship between the preoperative nutrition status and the postoperative&#xD;
      nutrition status in gastrointestinal cancer patients ?&#xD;
&#xD;
      Secondary Questions&#xD;
&#xD;
      - What is the relationship between malnutrition during preoperative and postoperative stages,&#xD;
      compared with postoperative complications?&#xD;
&#xD;
      OBJECTIVE :&#xD;
&#xD;
      The objective of this study is to study the association between pre- and postoperative&#xD;
      nutrition status compared with postoperative complications and surgical outcome. The results&#xD;
      of this study may affect future nutrition practices and encourage different behaviors in&#xD;
      gastrointestinal cancer patients who prepare to undergo surgery.&#xD;
&#xD;
      Sample size is calculated by n=(z_(1-α/2)^2 p(1-p))/d^2&#xD;
&#xD;
      Proportion (p) = 0.80, Error (d) = 0.064 Alpha (α) = 0.05, Z(0.975) = 1.959964 Power = 0.80&#xD;
      Sample size (n) = 178 Include drop out 10 % = 196 patients&#xD;
&#xD;
      Patients:&#xD;
&#xD;
      For 196 gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who&#xD;
      underwent scheduled surgery. Every patient underwent nutritional assessment by NAF before&#xD;
      surgery and (1 &amp; 3 months) after surgery at in the Department of Surgery, Ramathibodi&#xD;
      Hospital and Buriram Hospital from 20 November 2018. Patients with incomplete documents were&#xD;
      excluded from this study.&#xD;
&#xD;
      DATA COLLECTION AND DATA ANALYSIS:&#xD;
&#xD;
        -  Pre-operative nutrition status assess by NAF&#xD;
&#xD;
        -  Post-operative nutrition status at 1 month and 3 months assess by NAF&#xD;
&#xD;
        -  All postoperative complications were collected according to Clavin-Dindo Classification8&#xD;
&#xD;
        -  All case were included in this study, following TNM staging and others pathologic&#xD;
           parameters :&#xD;
&#xD;
        -  Cancer type - Tumor grading&#xD;
&#xD;
        -  Lymph node metastasis - Tumor depth&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>1 month</time_frame>
    <description>The complication were collected according to Clavin-Dindo Classification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>3 month</time_frame>
    <description>The complication were collected according to Clavin-Dindo Classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operative nutrition status</measure>
    <time_frame>1 month</time_frame>
    <description>operative nutrition status assess by Nutrition Alert Form (NAF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operative nutrition status</measure>
    <time_frame>3 month</time_frame>
    <description>operative nutrition assess by Nutrition Alert Form (NAF)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1 month</time_frame>
    <description>Length of hospital stay</description>
  </other_outcome>
  <enrollment type="Actual">196</enrollment>
  <condition>Digestive System Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who&#xD;
        underwent scheduled surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients GI cancer&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of oncologic treatment information before surgery&#xD;
&#xD;
          -  No history of recurrent cancer or more than one cancer disease&#xD;
&#xD;
          -  Patients who have been diagnosed with Carcinomatosis peritonei during the operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chairat Supsamutchai, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chairat Supsamutchai</name>
      <address>
        <city>Bangkok</city>
        <state>Bankok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perioperative Nutritional Status</keyword>
  <keyword>Surgical Outcome in Digestive System Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03763526
org study id: 2018/526
nct id: NCT03763526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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)
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
observational model: Cohort
time perspective: Prospective
measure: postoperative complications
time frame: 1 month
description: The complication were collected according to Clavin-Dindo Classification
measure: postoperative complications
time frame: 3 month
description: The complication were collected according to Clavin-Dindo Classification
measure: operative nutrition status
time frame: 1 month
description: operative nutrition status assess by Nutrition Alert Form (NAF)
measure: operative nutrition status
time frame: 3 month
description: operative nutrition assess by Nutrition Alert Form (NAF)
measure: Length of hospital stay
time frame: 1 month
description: Length of hospital stay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chairat Supsamutchai, MD
role: Study Chair
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Digestive System Neoplasms