<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/NCT03257280</url>
  </required_header>
  <id_info>
    <org_study_id>DOPGT_2015</org_study_id>
    <nct_id>NCT03257280</nct_id>
  </id_info>
  <brief_title>Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)</brief_title>
  <official_title>Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Gastric Cancer Patients After Total Gastrectomy: A Prospective Randomized Control Trial (DOPGT_2015)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized controlled clinical trial to clarify the effect of early&#xD;
      oral nutrition introduction after total gastrectomy in gastric cancer patients on the length&#xD;
      of hospital stay, comparing an experimental group vs control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total gastrectomy is a high complexity surgery that involves a high morbid-mortality. In&#xD;
      our center, the postoperative management consisted in 1 week period of non oral intake and&#xD;
      total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the&#xD;
      correct function of the anastomosis, in witch case, a progressive oral diet is begin.&#xD;
&#xD;
      In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was&#xD;
      introduced in the surgical patients attempting to improve their postoperative course. This&#xD;
      new concept includes the preoperative advices related to the surgery, the intensive&#xD;
      mobilization after surgery, the early oral diet, and to avoid the routinary use of the&#xD;
      nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically&#xD;
      in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is&#xD;
      still no good evidence to sport these practice.&#xD;
&#xD;
      Based on the reasons exposed before, the investigators design a prospective randomized&#xD;
      controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two&#xD;
      groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and&#xD;
      if no evidence of drainage leakage the participants will be randomized into two groups: one&#xD;
      of them with our classical postoperative management, and the other one implements an early&#xD;
      oral nutrition protocol, having in considerations its effectiveness, security, and impact on&#xD;
      the hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Postoperatory hospital stay in days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>During the admission, two weeks and one month after surgery</time_frame>
    <description>Postoperative Mortality: Deaths occurring during admission and / or within 30 days after surgery or during surgical admission if it lasts longer than 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmissions</measure>
    <time_frame>Two weeks and one month after surgery</time_frame>
    <description>It will be considered the income produced within 30 days after the surgical intervention in which the cause of the admission is attributed to a complication in relation to the surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>First day of hospital admission, two weeks and one month after surgery</time_frame>
    <description>weight shall be measured in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anastomotic dehiscence</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Anastomotic dehiscence: If the intra-abdominal drainage presents a purulent appearance or an amylase determination&gt; 30, suspicion of anastomosis dehiscence will be made; In this situation, a clinical test (intake of methylene blue) radiological test (with oral contrast) or endoscopy will be requested to confirm the diagnosis. Anastomosis dehiscence will be confirmed if any of the following occurs:&#xD;
Exit of methylene blue through intra-abdominal drainage&#xD;
Contrast leakage in a radiological test performed for sepsis&#xD;
Evidence of dehiscence in a fibrogastroscopy&#xD;
Evidence of anastomotic dehiscence during a reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duodenal stump leak</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Intra-abdominal drainage presents a purulent appearance with amylase determination&gt; 30 and a bilirubin value higher than plasmatic bilirubin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paralytic ileus</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>When three of the following criteria are met.&#xD;
Oral intolerance after the fourth postoperative day Abdominal distention and tympanism No bowel motions or flatus Compatible abdominal x-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-Abdominal abscesses</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Radiological criteria:&#xD;
Air inside the collection Collection with heterogeneous and irregular pickup or wall pickup Collection with heterogeneous content&#xD;
Isolation of one or more microorganisms in culture after percutaneous collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Hemoperitoneum</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Presence of blood in the abdominal cavity after gastrectomy that needs any kind of treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evisceration</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Extrusion of viscera outside the body through a surgical incision</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superficial Incisional Surgical Site Infection</measure>
    <time_frame>postoperative 1 day to discharge, up to 1 month after surgery</time_frame>
    <description>Superficial Incisional Surgical Site Infection&#xD;
Infection within 30 days after the operation and only involves skin and subcutaneous tissue of the incision and at least one of the following:&#xD;
Purulent drainage with or without laboratory confirmation, from the superficial incision.&#xD;
Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.&#xD;
At least one of the following signs or symptoms of infection: pain or tenderness, localised swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.&#xD;
Diagnosis of superficial incisional surgical site infection made by a surgeon or attending physician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>First day of hospital admission, two weeks and one month after surgery</time_frame>
    <description>Height shall be measured in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of weight lost</measure>
    <time_frame>First day of hospital admission, two weeks and one month after surgery</time_frame>
    <description>Percentage of weight lost shall be measured in percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impedancemetry</measure>
    <time_frame>First day of hospital admission, two weeks and one month after surgery</time_frame>
    <description>The impedanciometry will record:&#xD;
Phase-angle Na / K ratio Basal metabolism (Kcal) Fat mass percentage Muscle mass percentage Cell mass percentage Extracellular mass percentage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Early Oral Nutrition After Total Gastrectomy</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Early oral nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In our center, the classical postoperative management consisted in one week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a three days progressive oral diet is begin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early oral nutrition</intervention_name>
    <description>An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.</description>
    <arm_group_label>Early oral nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients requiring radical total gastrectomy for gastric cancer.&#xD;
&#xD;
          -  18 or above years old.&#xD;
&#xD;
          -  Acceptance and signing the full informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with poorly controlled diabetes mellitus (glycosylated hemoglobin levels&#xD;
             greater than 7%)&#xD;
&#xD;
          -  Emergency surgery.&#xD;
&#xD;
          -  Total gastrectomy with esophagus-jejunal manual suture.&#xD;
&#xD;
          -  Early dehiscence of esophagus-jejunal anastomosis (first 24 hours).&#xD;
&#xD;
          -  Reintervention for abdominal complication in the first 24 hours.&#xD;
&#xD;
          -  Surgery involving large intestinal or colon resections.&#xD;
&#xD;
          -  Proximal resection margin affected requiring a esophagectomy and reconstruction with&#xD;
             coloplasty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leandre Farran Teixidor, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bellvitge University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leandre Farran Teixidor, PhD, MD</last_name>
    <phone>+34-93-335-90-11</phone>
    <phone_ext>2316</phone_ext>
    <email>lfarran@bellvitgehospital.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fernando Estremiana Garcia, MD</last_name>
    <phone>+34-93-335-90-11</phone>
    <phone_ext>2316</phone_ext>
    <email>festremiana@bellvitgehospital.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Leandre Farran Teixidor</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leandre Farran Teixidor, PhD, MD</last_name>
      <phone>+34-93-335-90-11</phone>
      <phone_ext>2316</phone_ext>
      <email>lfarran@bellvitgehospital.cat</email>
    </contact>
    <contact_backup>
      <last_name>Fernando Estremiana Garcia, MD</last_name>
      <phone>+34-93-335-90-11</phone>
      <phone_ext>2316</phone_ext>
      <email>festremiana@bellvitgehospital.cat</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
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    <citation>Mabvuure NT, Roman A, Khan OA. Enteral immunonutrition versus standard enteral nutrition for patients undergoing oesophagogastric resection for cancer. Int J Surg. 2013;11(2):122-7. doi: 10.1016/j.ijsu.2012.12.012. Epub 2012 Dec 26. Erratum In: Int J Surg. 2014;12(5):549. Roman, Ina [corrected to Roman, Alexandrina].</citation>
    <PMID>23274278</PMID>
  </reference>
  <reference>
    <citation>Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.</citation>
    <PMID>25047143</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Leandre Farran Teixidor</investigator_full_name>
    <investigator_title>Chief of oesophagogastric surgery department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT03257280
org study id: DOPGT_2015
nct id: NCT03257280
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomized controlled clinical trial to clarify the effect of early
      oral nutrition introduction after total gastrectomy in gastric cancer patients on the length
      of hospital stay, comparing an experimental group vs control group.
The total gastrectomy is a high complexity surgery that involves a high morbid-mortality. In
      our center, the postoperative management consisted in 1 week period of non oral intake and
      total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the
      correct function of the anastomosis, in witch case, a progressive oral diet is begin.

      In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was
      introduced in the surgical patients attempting to improve their postoperative course. This
      new concept includes the preoperative advices related to the surgery, the intensive
      mobilization after surgery, the early oral diet, and to avoid the routinary use of the
      nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically
      in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is
      still no good evidence to sport these practice.

      Based on the reasons exposed before, the investigators design a prospective randomized
      controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two
      groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and
      if no evidence of drainage leakage the participants will be randomized into two groups: one
      of them with our classical postoperative management, and the other one implements an early
      oral nutrition protocol, having in considerations its effectiveness, security, and impact on
      the hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Hospital stay
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Postoperatory hospital stay in days
measure: Mortality
time frame: During the admission, two weeks and one month after surgery
description: Postoperative Mortality: Deaths occurring during admission and / or within 30 days after surgery or during surgical admission if it lasts longer than 30 days.
measure: Hospital readmissions
time frame: Two weeks and one month after surgery
description: It will be considered the income produced within 30 days after the surgical intervention in which the cause of the admission is attributed to a complication in relation to the surgical intervention.
measure: Weight
time frame: First day of hospital admission, two weeks and one month after surgery
description: weight shall be measured in kilograms
measure: Anastomotic dehiscence
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Anastomotic dehiscence: If the intra-abdominal drainage presents a purulent appearance or an amylase determination> 30, suspicion of anastomosis dehiscence will be made; In this situation, a clinical test (intake of methylene blue) radiological test (with oral contrast) or endoscopy will be requested to confirm the diagnosis. Anastomosis dehiscence will be confirmed if any of the following occurs:
Exit of methylene blue through intra-abdominal drainage
Contrast leakage in a radiological test performed for sepsis
Evidence of dehiscence in a fibrogastroscopy
Evidence of anastomotic dehiscence during a reintervention
measure: Duodenal stump leak
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Intra-abdominal drainage presents a purulent appearance with amylase determination> 30 and a bilirubin value higher than plasmatic bilirubin.
measure: Paralytic ileus
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: When three of the following criteria are met.
Oral intolerance after the fourth postoperative day Abdominal distention and tympanism No bowel motions or flatus Compatible abdominal x-ray
measure: Intra-Abdominal abscesses
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Radiological criteria:
Air inside the collection Collection with heterogeneous and irregular pickup or wall pickup Collection with heterogeneous content
Isolation of one or more microorganisms in culture after percutaneous collection
measure: Postoperative Hemoperitoneum
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Presence of blood in the abdominal cavity after gastrectomy that needs any kind of treatments
measure: Evisceration
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Extrusion of viscera outside the body through a surgical incision
measure: Superficial Incisional Surgical Site Infection
time frame: postoperative 1 day to discharge, up to 1 month after surgery
description: Superficial Incisional Surgical Site Infection
Infection within 30 days after the operation and only involves skin and subcutaneous tissue of the incision and at least one of the following:
Purulent drainage with or without laboratory confirmation, from the superficial incision.
Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
At least one of the following signs or symptoms of infection: pain or tenderness, localised swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.
Diagnosis of superficial incisional surgical site infection made by a surgeon or attending physician.
measure: Height
time frame: First day of hospital admission, two weeks and one month after surgery
description: Height shall be measured in meters
measure: Percentage of weight lost
time frame: First day of hospital admission, two weeks and one month after surgery
description: Percentage of weight lost shall be measured in percentage
measure: Impedancemetry
time frame: First day of hospital admission, two weeks and one month after surgery
description: The impedanciometry will record:
Phase-angle Na / K ratio Basal metabolism (Kcal) Fat mass percentage Muscle mass percentage Cell mass percentage Extracellular mass percentage
arm group label: Early oral nutrition
arm group type: Experimental
description: An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
arm group label: control group
arm group type: No Intervention
description: In our center, the classical postoperative management consisted in one week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a three days progressive oral diet is begin.
intervention type: Other
intervention name: Early oral nutrition
description: An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
arm group label: Early oral nutrition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leandre Farran Teixidor, PhD, MD
role: Principal Investigator
affiliation: Bellvitge University Hospital
last name: Leandre Farran Teixidor, PhD, MD
phone: +34-93-335-90-11
phone ext: 2316
email: lfarran@bellvitgehospital.cat
last name: Fernando Estremiana Garcia, MD
phone: +34-93-335-90-11
phone ext: 2316
email: festremiana@bellvitgehospital.cat
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
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PMID: 25047143
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Leandre Farran Teixidor
investigator title: Chief of oesophagogastric surgery department
mesh term: Stomach Neoplasms