<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/NCT04436159</url>
  </required_header>
  <id_info>
    <org_study_id>2008/179-31</org_study_id>
    <nct_id>NCT04436159</nct_id>
  </id_info>
  <brief_title>Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.</brief_title>
  <official_title>Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ersta Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska University 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>
      Short-term follow up after surgery of para-esophageal hernia comparing two different types of&#xD;
      fundoplication&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective&#xD;
      treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should&#xD;
      be included in the hiatal reconstruction in order to reduce the risk of postoperative&#xD;
      gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be&#xD;
      recommend is yet to be determined.&#xD;
&#xD;
      One might argue that the overall durability and effectiveness of a partial fundoplication in&#xD;
      the control of reflux might be less reliable than a total wrap, but on the contrary, the&#xD;
      latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.&#xD;
&#xD;
      We therefore designed a double blind randomized clinical trial in which patients with&#xD;
      symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total&#xD;
      (Nissen) fundoplication after hernia reduction and crural repair.&#xD;
&#xD;
      Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery&#xD;
      of para-esophageal hernia with addition of total fundoplication vs posterial partial&#xD;
      fundoplication.&#xD;
&#xD;
      Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36:&#xD;
      physical and mental component scores.&#xD;
&#xD;
      Time points: 1, 3 and 6 months after surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2009</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ogilvie dysphagia score</measure>
    <time_frame>6 months</time_frame>
    <description>The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intra-and postoperative courses</measure>
    <time_frame>6 mohths</time_frame>
    <description>Peri and postoperative complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>6 months</time_frame>
    <description>postoperative length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Watson dysphagia score</measure>
    <time_frame>6 months</time_frame>
    <description>Watson dysphagia score is a validated instrument for benign dysphagia where the patient is asked whether he/she always, sometimes or never has difficulty swallowing nine different groups of liquid and food items.&#xD;
This gives a score ranging from zero to 45, where 45 represents the worst possible dysphagia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acid reflux control</measure>
    <time_frame>6 months</time_frame>
    <description>24-hour pH monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (SF-36)</measure>
    <time_frame>6 months</time_frame>
    <description>The Swedish version of this validated global questionnaire is presented as physical and mental summary component scores (PCS and MCS, respectively). Each subscale scores reaches a value of at the most 100, where higher values reflect better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiology</measure>
    <time_frame>6 months</time_frame>
    <description>Radiologically verified recurrent hiatal hernia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Paraesophageal Hernia</condition>
  <condition>Gastro Esophageal Reflux</condition>
  <arm_group>
    <arm_group_label>Nissen fundoplication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Addition of 360 fundoplication after crural closure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Toupet fundoplication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Addition of 180 posterior fundoplication after crural closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Addition of 360 fundoplication after crural closure</intervention_name>
    <description>A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.</description>
    <arm_group_label>Nissen fundoplication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Addition of 180 posterior fundoplication after crural closure</intervention_name>
    <description>The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures.&#xD;
Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively.</description>
    <arm_group_label>Toupet fundoplication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital&#xD;
             and Karolinska University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 18 years&#xD;
&#xD;
          -  axial sliding hiatal hernia only (type I)&#xD;
&#xD;
          -  missing informed consent&#xD;
&#xD;
          -  previous hiatal hernia surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score IV or above&#xD;
&#xD;
          -  achalasia&#xD;
&#xD;
          -  Zollinger-Ellison syndrome&#xD;
&#xD;
          -  malignant tumor&#xD;
&#xD;
          -  inability or unwillingness to complete questionnaires&#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>Lars Lundell, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ersta Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 28, 2021</last_update_submitted>
  <last_update_submitted_qc>August 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Lars Lundell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Nissen fundoplication</keyword>
  <keyword>Toupet fundoplication</keyword>
  <keyword>crural repair</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Hiatal</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/NCT04436159
org study id: 2008/179-31
nct id: NCT04436159
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Short-term follow up after surgery of para-esophageal hernia comparing two different types of
      fundoplication
Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective
      treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should
      be included in the hiatal reconstruction in order to reduce the risk of postoperative
      gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be
      recommend is yet to be determined.

      One might argue that the overall durability and effectiveness of a partial fundoplication in
      the control of reflux might be less reliable than a total wrap, but on the contrary, the
      latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.

      We therefore designed a double blind randomized clinical trial in which patients with
      symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total
      (Nissen) fundoplication after hernia reduction and crural repair.

      Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery
      of para-esophageal hernia with addition of total fundoplication vs posterial partial
      fundoplication.

      Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36:
      physical and mental component scores.

      Time points: 1, 3 and 6 months after surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ogilvie dysphagia score
time frame: 6 months
description: The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .
measure: intra-and postoperative courses
time frame: 6 mohths
description: Peri and postoperative complications.
measure: length of hospital stay
time frame: 6 months
description: postoperative length of hospital stay
measure: Watson dysphagia score
time frame: 6 months
description: Watson dysphagia score is a validated instrument for benign dysphagia where the patient is asked whether he/she always, sometimes or never has difficulty swallowing nine different groups of liquid and food items.
This gives a score ranging from zero to 45, where 45 represents the worst possible dysphagia.
measure: Acid reflux control
time frame: 6 months
description: 24-hour pH monitoring
measure: Quality of Life (SF-36)
time frame: 6 months
description: The Swedish version of this validated global questionnaire is presented as physical and mental summary component scores (PCS and MCS, respectively). Each subscale scores reaches a value of at the most 100, where higher values reflect better health status.
measure: Radiology
time frame: 6 months
description: Radiologically verified recurrent hiatal hernia
arm group label: Nissen fundoplication
arm group type: Active Comparator
description: Addition of 360 fundoplication after crural closure
arm group label: Toupet fundoplication
arm group type: Active Comparator
description: Addition of 180 posterior fundoplication after crural closure
intervention type: Procedure
intervention name: Addition of 360 fundoplication after crural closure
description: A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.
arm group label: Nissen fundoplication
intervention type: Procedure
intervention name: Addition of 180 posterior fundoplication after crural closure
description: The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures.
Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively.
arm group label: Toupet fundoplication
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Lundell, professor
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Lars Lundell
investigator title: Professor
mesh term: Gastroesophageal Reflux
mesh term: Hernia
mesh term: Hernia, Hiatal
sharing ipd: No