<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/NCT04433338</url>
  </required_header>
  <id_info>
    <org_study_id>NL70092.081.19</org_study_id>
    <nct_id>NCT04433338</nct_id>
  </id_info>
  <brief_title>The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery</brief_title>
  <official_title>The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rijnstate Hospital</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>
      Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical&#xD;
      complications. However, results in the literature on the improvement of surgical procedure&#xD;
      and outcomes are still conflicting.&#xD;
&#xD;
      This study aims to evaluate the effect of preoperative weight loss by means of a 14-day&#xD;
      low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric&#xD;
      bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">July 2027</completion_date>
  <primary_completion_date type="Actual">June 22, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time of the RYGB procedure</measure>
    <time_frame>surgery</time_frame>
    <description>Duration of the surgical procedure, retrieved from the electronic medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of the RYGB procedure</measure>
    <time_frame>surgery</time_frame>
    <description>Ten aspects of the RYGB procedure will be scored on a 5-point Likert scale. The total score can range from 10 to 50, with 10 being the easiest.&#xD;
The ten aspects include:&#xD;
Exerting force on instruments (1=very low, 5= very high)&#xD;
Difficulty of moving the liver (1=very easy, 5=very difficult)&#xD;
Size of the liver (1=very small, 5= very large)&#xD;
Size of omentum (1=very small, 5= very large)&#xD;
Difficulty of approaching pouch (1=very easy, 5=very difficult)&#xD;
Accessibility of Treitz ligament (1=very easy, 5=very difficult)&#xD;
Difficulty of creating pouch (1=very easy, 5=very difficult)&#xD;
Difficulty of measuring small intestine (1=very easy, 5=very difficult)&#xD;
Difficulty of entero-entero connection (1=very easy, 5=very difficult)&#xD;
Difficulty of abdominal wall hernia repair (1=very easy, 5=very difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appearance of the patient's liver</measure>
    <time_frame>surgery</time_frame>
    <description>Includes four images of the liver in different stages (1= healthy, 2= fatty liver, 3= fatty liver with inflammation, 4= liver cirrhosis). Surgeons will be asked to choose the image that best matches the appearance of the patient's liver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative weight loss</measure>
    <time_frame>4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery</time_frame>
    <description>Body weight measurements to assess weight loss after surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility of the diet</measure>
    <time_frame>During the 14-day intervention period</time_frame>
    <description>Feasibility will be assessed via questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Compliance of the diet</measure>
    <time_frame>During the 14-day intervention period</time_frame>
    <description>Compliance will be assessed via food records</description>
  </other_outcome>
  <other_outcome>
    <measure>Complication rate</measure>
    <time_frame>First 30 days post-surgery</time_frame>
    <description>All short term complications during the first 30 days will be recorded and classified according to the Clavien-Dindo classification</description>
  </other_outcome>
  <other_outcome>
    <measure>Wound healing</measure>
    <time_frame>4 weeks</time_frame>
    <description>Degree of wound healing post-surgery will be checked based on appearance on a 5-point Likert scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Bariatric Surgery</condition>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention group will follow a low-calorie diet during 14 days before undergoing surgery. The diet will consist of both meal replacements and regular foods.&#xD;
For women, the diet provides ± 900 kcal, 50 grams of carbohydrates, 85 grams of protein, 30 grams of fat and 25 grams of fibres.&#xD;
For men, the diet provides ± 1000 kcal, 55 grams of carbohydrates, 100 grams of protein, 30 grams of fat and 30 grams of fibres.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group can eat according to the standard nutritional advices provided by their dietitian. These advices are intended to educate participants on the recommended eating pattern after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>14-day Low Calorie Diet</intervention_name>
    <description>Participants will be asked to:&#xD;
Use 4 (women) or 5 (men) Modifast meal replacements per day.&#xD;
Daily consume a minimum of 250 grams of (raw) vegetables without dressing.&#xD;
Daily consume 100 grams of lean meat/fish/meat analogues.&#xD;
Daily consume two spoons of liquid oil&#xD;
Daily drink at least 2.0 litres of water, coffee or tea without added sugar or milk, bouillon or sugar-free drinks.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)&#xD;
&#xD;
          -  Able to prepare the meal replacements at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergoing another bariatric procedure than primary RYGB.&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Contraindication for the usage of Modifast meal replacements:&#xD;
&#xD;
               -  Allergy or intolerance to any substance in the used meal replacements (Soy, milk,&#xD;
                  gluten, egg, peanuts, nuts and seeds)&#xD;
&#xD;
               -  Veganism&#xD;
&#xD;
               -  Kidney failure (GFR &lt; 90 ml/min/1.73m2), liver failure or cardiac insufficiency&#xD;
&#xD;
               -  A heart attack (myocardial infarct) in the past twelve months&#xD;
&#xD;
               -  Cancer&#xD;
&#xD;
               -  Hypokalaemia: serum potassium level &lt;3.4 mmol/l&#xD;
&#xD;
               -  Phenylketonuria &amp; Porphyria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric J Hazebroek, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vitalys, part of Rijnstate hospital/Wageningen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6811AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Morbid Obesity</keyword>
  <keyword>Weight Loss</keyword>
  <keyword>Diet</keyword>
  <keyword>RYGB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <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/NCT04433338
org study id: NL70092.081.19
nct id: NCT04433338
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical
      complications. However, results in the literature on the improvement of surgical procedure
      and outcomes are still conflicting.

      This study aims to evaluate the effect of preoperative weight loss by means of a 14-day
      low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric
      bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative time of the RYGB procedure
time frame: surgery
description: Duration of the surgical procedure, retrieved from the electronic medical record
measure: Ease of the RYGB procedure
time frame: surgery
description: Ten aspects of the RYGB procedure will be scored on a 5-point Likert scale. The total score can range from 10 to 50, with 10 being the easiest.
The ten aspects include:
Exerting force on instruments (1=very low, 5= very high)
Difficulty of moving the liver (1=very easy, 5=very difficult)
Size of the liver (1=very small, 5= very large)
Size of omentum (1=very small, 5= very large)
Difficulty of approaching pouch (1=very easy, 5=very difficult)
Accessibility of Treitz ligament (1=very easy, 5=very difficult)
Difficulty of creating pouch (1=very easy, 5=very difficult)
Difficulty of measuring small intestine (1=very easy, 5=very difficult)
Difficulty of entero-entero connection (1=very easy, 5=very difficult)
Difficulty of abdominal wall hernia repair (1=very easy, 5=very difficult)
measure: Appearance of the patient's liver
time frame: surgery
description: Includes four images of the liver in different stages (1= healthy, 2= fatty liver, 3= fatty liver with inflammation, 4= liver cirrhosis). Surgeons will be asked to choose the image that best matches the appearance of the patient's liver.
measure: Post-operative weight loss
time frame: 4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery
description: Body weight measurements to assess weight loss after surgery
measure: Feasibility of the diet
time frame: During the 14-day intervention period
description: Feasibility will be assessed via questionnaires
measure: Compliance of the diet
time frame: During the 14-day intervention period
description: Compliance will be assessed via food records
measure: Complication rate
time frame: First 30 days post-surgery
description: All short term complications during the first 30 days will be recorded and classified according to the Clavien-Dindo classification
measure: Wound healing
time frame: 4 weeks
description: Degree of wound healing post-surgery will be checked based on appearance on a 5-point Likert scale.
arm group label: Intervention group
arm group type: Experimental
description: Participants in the intervention group will follow a low-calorie diet during 14 days before undergoing surgery. The diet will consist of both meal replacements and regular foods.
For women, the diet provides ± 900 kcal, 50 grams of carbohydrates, 85 grams of protein, 30 grams of fat and 25 grams of fibres.
For men, the diet provides ± 1000 kcal, 55 grams of carbohydrates, 100 grams of protein, 30 grams of fat and 30 grams of fibres.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group can eat according to the standard nutritional advices provided by their dietitian. These advices are intended to educate participants on the recommended eating pattern after surgery.
intervention type: Other
intervention name: 14-day Low Calorie Diet
description: Participants will be asked to:
Use 4 (women) or 5 (men) Modifast meal replacements per day.
Daily consume a minimum of 250 grams of (raw) vegetables without dressing.
Daily consume 100 grams of lean meat/fish/meat analogues.
Daily consume two spoons of liquid oil
Daily drink at least 2.0 litres of water, coffee or tea without added sugar or milk, bouillon or sugar-free drinks.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Eric J Hazebroek, MD, PhD
role: Principal Investigator
affiliation: Vitalys, part of Rijnstate hospital/Wageningen University
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Obesity, Morbid
mesh term: Weight Loss
sharing ipd: No