<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/NCT01679418</url>
  </required_header>
  <id_info>
    <org_study_id>PONV_thyroidsurgery</org_study_id>
    <nct_id>NCT01679418</nct_id>
  </id_info>
  <brief_title>Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery</brief_title>
  <acronym>PONTS</acronym>
  <official_title>Randomized Controlled Trial on the Impact of Postoperative Drainage on Nausea and Vomiting After Thyroid- and Parathyroid Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Liestal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Liestal</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and&#xD;
      Vomiting (PONV)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients&#xD;
      describe PONV as more irritant in the postoperative course than the endured pain.&#xD;
      Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect&#xD;
      wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is&#xD;
      not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and&#xD;
      parathyroid surgery in a randomized controlled clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of post-operative nausea using visual analogue scale (VAS)</measure>
    <time_frame>24 hours post surgery</time_frame>
    <description>The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of postoperative vomiting using visual analogue scale (VAS)</measure>
    <time_frame>24 hours post surgery</time_frame>
    <description>The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of post-operative nausea using visual analogue scale (VAS)</measure>
    <time_frame>48 hours post surgery</time_frame>
    <description>The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of postoperative vomiting using visual analogue scale (VAS)</measure>
    <time_frame>48 hours post surgery</time_frame>
    <description>The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antiemetic therapy post surgery in patients with and without postoperative drainage</measure>
    <time_frame>after 48 hours</time_frame>
    <description>In the postoperative course, we counted the amount of anti-emetic interventions for patients post surgery over the first 48 hours. The givage of anti-emetic drugs was based on a prior determined protocol, that was strictly followed.&#xD;
The protocol was as follows for antiemetic drugs:&#xD;
First line Drug: Tropisetron 2 mg i.v. when patient is vomiting, max. twice a day. Second line therapy: Haloperidol 0.5 mg i.v. with a maximum of 3 mg every 24 hours, when first line therapy is not sufficient. The change to second line therapy is controlled by the study physician.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Drain placement (Group A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in group A received a wound drain after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-drain placement (group B)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients assigned to group B, did not receive a wound drain after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placement of a wound drain post surgery (Redon; Medicoplast)</intervention_name>
    <description>The wound drain, type Redon Drainage 3.0 mm in diameter</description>
    <arm_group_label>Drain placement (Group A)</arm_group_label>
    <other_name>Redon Drainage (Ref. 750), 3.0 mm in diameter</other_name>
    <other_name>Medicoplast, 66557 Illingen, Germany</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No-drain after surgery</intervention_name>
    <description>After surgery, no drain was put</description>
    <arm_group_label>No-drain placement (group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years of age&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  planed thyroid- or parathyroid resection&#xD;
&#xD;
          -  euthyreostatic preoperative condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years of age&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  retrosternal struma&#xD;
&#xD;
          -  known postoperative nausea and vomiting prior to surgery&#xD;
&#xD;
          -  severe and life threatening systemic health issues&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph A Maurer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Professor of Surgery, Head of the Department, Kantonsspital Liestal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Liestal</name>
      <address>
        <city>Liestal</city>
        <state>Basel-Landschaft</state>
        <zip>4410</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Schwarz W, Willy C, Ndjee C. [Gravity or suction drainage in thyroid surgery? Control of efficacy with ultrasound determination of residual hematoma]. Langenbecks Arch Chir. 1996;381(6):337-42. doi: 10.1007/BF00191314. Erratum In: Langenbecks Arch Chir 1997;382(2):116. German.</citation>
    <PMID>9082107</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>June 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>February 24, 2016</last_update_submitted>
  <last_update_submitted_qc>February 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Liestal</investigator_affiliation>
    <investigator_full_name>Christoph A. Maurer, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>PONV</keyword>
  <keyword>thyroid</keyword>
  <keyword>surgery</keyword>
  <keyword>nausea and vomiting</keyword>
  <keyword>postoperative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</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/NCT01679418
org study id: PONV_thyroidsurgery
nct id: NCT01679418
lead sponsor: 
has dmc: Yes
Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and
      Vomiting (PONV)
Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients
      describe PONV as more irritant in the postoperative course than the endured pain.
      Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect
      wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is
      not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and
      parathyroid surgery in a randomized controlled clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Assessment of post-operative nausea using visual analogue scale (VAS)
time frame: 24 hours post surgery
description: The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.
measure: Assessment of postoperative vomiting using visual analogue scale (VAS)
time frame: 24 hours post surgery
description: The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery
measure: Assessment of post-operative nausea using visual analogue scale (VAS)
time frame: 48 hours post surgery
description: The development of postoperative nausea was determined using a standard visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of nausea a number between 0 to 10.
measure: Assessment of postoperative vomiting using visual analogue scale (VAS)
time frame: 48 hours post surgery
description: The development of postoperative vomiting was determined using a standard Visual analogue scale (VAS) with range of 0 to 10. 0 indicated no nausea, 10 indicated very severe nausea. The patients indicated their felt degree of vomiting indicating a number between 0 to 10. The number of vomiting was counted within the first 48h post surgery
measure: Antiemetic therapy post surgery in patients with and without postoperative drainage
time frame: after 48 hours
description: In the postoperative course, we counted the amount of anti-emetic interventions for patients post surgery over the first 48 hours. The givage of anti-emetic drugs was based on a prior determined protocol, that was strictly followed.
The protocol was as follows for antiemetic drugs:
First line Drug: Tropisetron 2 mg i.v. when patient is vomiting, max. twice a day. Second line therapy: Haloperidol 0.5 mg i.v. with a maximum of 3 mg every 24 hours, when first line therapy is not sufficient. The change to second line therapy is controlled by the study physician.
arm group label: Drain placement (Group A)
arm group type: Active Comparator
description: Patients in group A received a wound drain after surgery.
arm group label: No-drain placement (group B)
arm group type: Sham Comparator
description: Patients assigned to group B, did not receive a wound drain after surgery.
intervention type: Device
intervention name: Placement of a wound drain post surgery (Redon; Medicoplast)
description: The wound drain, type Redon Drainage 3.0 mm in diameter
arm group label: Drain placement (Group A)
other name: Redon Drainage (Ref. 750), 3.0 mm in diameter
other name: Medicoplast, 66557 Illingen, Germany
intervention type: Other
intervention name: No-drain after surgery
description: After surgery, no drain was put
arm group label: No-drain placement (group B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Christoph A Maurer, MD
role: Study Director
affiliation: Professor of Surgery, Head of the Department, Kantonsspital Liestal
facility: 
country: Switzerland
citation: Schwarz W, Willy C, Ndjee C. [Gravity or suction drainage in thyroid surgery? Control of efficacy with ultrasound determination of residual hematoma]. Langenbecks Arch Chir. 1996;381(6):337-42. doi: 10.1007/BF00191314. Erratum In: Langenbecks Arch Chir 1997;382(2):116. German.
PMID: 9082107
responsible party type: Principal Investigator
investigator affiliation: Kantonsspital Liestal
investigator full name: Christoph A. Maurer, MD
investigator title: Principal investigator
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting