<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/NCT01669330</url>
  </required_header>
  <id_info>
    <org_study_id>NW20012011</org_study_id>
    <nct_id>NCT01669330</nct_id>
  </id_info>
  <brief_title>Laparoscopic Nissen Versus Anterior Partial Fundoplication</brief_title>
  <official_title>Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most widely used operative technique for gastroesophageal reflux is total fundoplication&#xD;
      where the gastric fundus is sutured around the distal esophagus like a wrap. This operation&#xD;
      effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related&#xD;
      to over-competence of the gastroesophageal junction. 40% of the operated patients experience&#xD;
      increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique&#xD;
      where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of&#xD;
      the front wall of the esophagus is covered with fundus. An anterior fundoplication is un&#xD;
      attempt to create a more physiologic reflux control and less functional problems&#xD;
      postoperatively. The aim with this study is to compare the results postoperatively, both&#xD;
      short time and long time results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To establish if there is a difference in the incidence of postoperative flatulence after&#xD;
      the two different operative techniques. The secondary aims are to establish differences in&#xD;
      relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital&#xD;
      stay, sick-leave and complications.&#xD;
&#xD;
      Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are&#xD;
      randomised between the two operations. Postoperatively, telephone interview is performed&#xD;
      weekly the first two months. One year and ten years postoperatively. The patients are&#xD;
      investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom&#xD;
      evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2001</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative flatulence?</measure>
    <time_frame>Postoperative one year</time_frame>
    <description>To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse? Complications? Functional problems?</measure>
    <time_frame>Postoperatively three months, one year and ten years</time_frame>
    <description>To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Gastroesophageal Reflux</condition>
  <arm_group>
    <arm_group_label>Total fundoplication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: Laparoscopic Nissen fundoplication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anterior partial fundoplication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: Laparoscopic anterior partial fundoplication</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nissen fundoplication</intervention_name>
    <description>Laparoscopic Nissen fundoplication</description>
    <arm_group_label>Total fundoplication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic antireflux surgery ad modum Watson</intervention_name>
    <description>Laparoscopic anterior fundoplication</description>
    <arm_group_label>Anterior partial fundoplication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:18-65 years.&#xD;
&#xD;
          -  Good results of PPI treatment (&lt;3 months) resulting in reduced heart burn and acid&#xD;
             regurgitations.&#xD;
&#xD;
          -  Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery on the stomach&#xD;
&#xD;
          -  Patients with IBS (criteria ROM II)&#xD;
&#xD;
          -  Severe disease, for example diabetes mellitus, cardiopulmonary disease or renal&#xD;
             disease, that would influence outcome measurement&#xD;
&#xD;
          -  Patients with active ulcer disease&#xD;
&#xD;
          -  Paraesophageal hernia&#xD;
&#xD;
          -  Patient that are incapable to understand the study information (for example mentally&#xD;
             disorder, drug abuse)&#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>Pauline Djerf, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Skane</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery</name>
      <address>
        <city>Kalmar</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Surgery</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Surgery</name>
      <address>
        <city>Malmö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Surgery</name>
      <address>
        <city>Trollhättan</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>November 22, 2011</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>April 9, 2014</last_update_submitted>
  <last_update_submitted_qc>April 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastroesophageal Reflux</keyword>
  <keyword>Fundoplication</keyword>
  <keyword>Surgical Procedures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</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/NCT01669330
org study id: NW20012011
nct id: NCT01669330
lead sponsor: 
has dmc: No
The most widely used operative technique for gastroesophageal reflux is total fundoplication
      where the gastric fundus is sutured around the distal esophagus like a wrap. This operation
      effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related
      to over-competence of the gastroesophageal junction. 40% of the operated patients experience
      increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique
      where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of
      the front wall of the esophagus is covered with fundus. An anterior fundoplication is un
      attempt to create a more physiologic reflux control and less functional problems
      postoperatively. The aim with this study is to compare the results postoperatively, both
      short time and long time results.
Aim: To establish if there is a difference in the incidence of postoperative flatulence after
      the two different operative techniques. The secondary aims are to establish differences in
      relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital
      stay, sick-leave and complications.

      Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are
      randomised between the two operations. Postoperatively, telephone interview is performed
      weekly the first two months. One year and ten years postoperatively. The patients are
      investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom
      evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative flatulence?
time frame: Postoperative one year
description: To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.
measure: Relapse? Complications? Functional problems?
time frame: Postoperatively three months, one year and ten years
description: To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.
arm group label: Total fundoplication
arm group type: Active Comparator
description: Procedure: Laparoscopic Nissen fundoplication
arm group label: Anterior partial fundoplication
arm group type: Active Comparator
description: Procedure: Laparoscopic anterior partial fundoplication
intervention type: Procedure
intervention name: Nissen fundoplication
description: Laparoscopic Nissen fundoplication
arm group label: Total fundoplication
intervention type: Procedure
intervention name: Laparoscopic antireflux surgery ad modum Watson
description: Laparoscopic anterior fundoplication
arm group label: Anterior partial fundoplication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pauline Djerf, Md
role: Principal Investigator
affiliation: Region Skane
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux