<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/NCT03749668</url>
  </required_header>
  <id_info>
    <org_study_id>2018-270</org_study_id>
    <nct_id>NCT03749668</nct_id>
  </id_info>
  <brief_title>Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP).</brief_title>
  <acronym>DIETERP</acronym>
  <official_title>Dietary Survey During the First Month After Colorectal Surgery Within an Enhanced Recovery Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      This observational study will quantify caloric-protein intake in 75 patients undergoing&#xD;
      colorectal surgery within an enhanced recovery program at CHU Liège. A dietary survey will be&#xD;
      performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day +&#xD;
      7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be&#xD;
      correlated with the medical and surgical characteristics of the patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for&#xD;
      colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of&#xD;
      Liège has been labelled as reference center for ERP after colorectal surgery by a&#xD;
      French-speaking organization GRACE (French-speaking group for Enhanced Recovery after&#xD;
      Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits&#xD;
      of such programs, some criticize ERP arguing that patients are asked to return home too&#xD;
      early, while they have not recovered a satisfactory autonomy. Few studies have investigated&#xD;
      the comfort and quality of home life of patients who have had ERP. We recently conducted a&#xD;
      retrospective study to evaluate this quality of life. It turns out that patients report&#xD;
      little postoperative pain, a sufficient degree of autonomy at home, and a high general&#xD;
      satisfaction score (&gt; 8.5 on a numerical scale of 0 to 10). However dietary and digestive&#xD;
      difficulties were described by about one third of the patients questioned. [6] Others have&#xD;
      also reported a caloric-protein deficit during the immediate postoperative period after&#xD;
      colorectal surgery, up to the 7th day in some of their patients [7].&#xD;
&#xD;
      Aim of the study. The aim of this study is to assess caloric-protein intake up to one month&#xD;
      after colorectal surgery within ERP.&#xD;
&#xD;
      General description. This observational study will quantify caloric-protein intake in 75&#xD;
      patients undergoing colorectal surgery according to an ERP at CHU Liège. A dietary survey&#xD;
      will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3,&#xD;
      Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be&#xD;
      correlated with the medical and surgical characteristics of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Actual">May 8, 2019</completion_date>
  <primary_completion_date type="Actual">May 8, 2019</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>calorie and protein intakes</measure>
    <time_frame>one month after hospital discharge</time_frame>
    <description>Using a dietary survey postoperative intake of calories and protein will be assessed in patients scheduled for colorectal surgery</description>
  </primary_outcome>
  <enrollment type="Actual">75</enrollment>
  <condition>Colorectal Surgery</condition>
  <condition>Calorie Deficiency</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non applicable</intervention_name>
    <description>no intervention in this observational study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient schedules for colorectal surgery with the ERP at CHU Liège (Belgium). Patients&#xD;
        age must be greater than 18 years. There is no maximum limit of age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient scheduled for colorectal surgery within an ERP at CHU Liège&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to answer the survey (cognitive disorders, bad knowledge of the French&#xD;
             language)&#xD;
&#xD;
          -  closure of loop ileostomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jean-François Brichant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Liege, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Jean François Brichant</investigator_full_name>
    <investigator_title>Head of the Anesthesiology department</investigator_title>
  </responsible_party>
  <keyword>surgery: colorectal</keyword>
  <keyword>enhanced recovery</keyword>
  <keyword>caloric intake</keyword>
  <keyword>protein intake</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03749668
org study id: 2018-270
nct id: NCT03749668
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study will quantify caloric-protein intake in 75 patients undergoing
      colorectal surgery within an enhanced recovery program at CHU Liège. A dietary survey will be
      performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day +
      7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be
      correlated with the medical and surgical characteristics of the patients
For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for
      colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of
      Liège has been labelled as reference center for ERP after colorectal surgery by a
      French-speaking organization GRACE (French-speaking group for Enhanced Recovery after
      Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits
      of such programs, some criticize ERP arguing that patients are asked to return home too
      early, while they have not recovered a satisfactory autonomy. Few studies have investigated
      the comfort and quality of home life of patients who have had ERP. We recently conducted a
      retrospective study to evaluate this quality of life. It turns out that patients report
      little postoperative pain, a sufficient degree of autonomy at home, and a high general
      satisfaction score (> 8.5 on a numerical scale of 0 to 10). However dietary and digestive
      difficulties were described by about one third of the patients questioned. [6] Others have
      also reported a caloric-protein deficit during the immediate postoperative period after
      colorectal surgery, up to the 7th day in some of their patients [7].

      Aim of the study. The aim of this study is to assess caloric-protein intake up to one month
      after colorectal surgery within ERP.

      General description. This observational study will quantify caloric-protein intake in 75
      patients undergoing colorectal surgery according to an ERP at CHU Liège. A dietary survey
      will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3,
      Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be
      correlated with the medical and surgical characteristics of the patients.
observational model: Cohort
time perspective: Prospective
measure: calorie and protein intakes
time frame: one month after hospital discharge
description: Using a dietary survey postoperative intake of calories and protein will be assessed in patients scheduled for colorectal surgery
intervention type: Other
intervention name: non applicable
description: no intervention in this observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jean-François Brichant, MD
role: Principal Investigator
affiliation: CHU Liege, Belgium
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Jean François Brichant
investigator title: Head of the Anesthesiology department
sharing ipd: No