<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/NCT03760341</url>
  </required_header>
  <id_info>
    <org_study_id>0087-14-RMB</org_study_id>
    <nct_id>NCT03760341</nct_id>
  </id_info>
  <brief_title>Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients</brief_title>
  <official_title>Does the Technique of Adenoidectomy Influence the Results of the Surgery? A Prospective Randomized Single Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      Background: Adenoidectomy is one of the most common procedures done by the otolaryngologist.&#xD;
      The procedure can be performed using the cold method (mainly adenoid curettes) or the hot&#xD;
      method (suction diathermy). Both techniques have similar intra and post-operative outcomes.&#xD;
      However, the long term clinical outcome in improving the sleep disorder symptoms was never&#xD;
      compared between the two methods.&#xD;
&#xD;
      Objective: To compare the advantages using the hot method compared to the cold method&#xD;
      adenoidectomy in the long term follow up.&#xD;
&#xD;
      Methods: A prospective, randomized, single blinded study of children undergoing adenoidectomy&#xD;
      between the years 2014-2017. Patients were randomized to hot or cold adenoidectomy&#xD;
      techniques. The primary outcome was change of the Pediatric Sleep Questionnaire Score (PSQ)&#xD;
      scores one month and one year after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common cause of sleep disordered breathing in children is enlargement of the&#xD;
      adenoids and tonsils relative to the upper airway space.&#xD;
&#xD;
      Obstructive sleep apnea could cause pulmonary and cardiovascular complications, and could&#xD;
      influence negatively the l quality of life of the child. Adenoidectomy with or without&#xD;
      tonsillectomy is one of the most common procedures done by the otolaryngologist.&#xD;
      Adenoidectomy is performed under general anesthesia .The main indications for the procedure&#xD;
      include adenoid hypertrophy, obstructive sleep apnea, chronic adenoiditis, and chronic otitis&#xD;
      media (ref 1).&#xD;
&#xD;
      Historically recommended instrumentation for performing adenoidectomy has varied from a steel&#xD;
      nail, cutting or biting forceps, adenotomes and adenoid curettes.&#xD;
&#xD;
      In 2009 the National institute for health and clinical excellence has published guidelines on&#xD;
      the use of suction diathermia adenoidectomy which showed that the method is as effective as&#xD;
      or even more than cold method, the method is considered more secure with some advantage in&#xD;
      terms of complications of adenoidectomy2, Several studies compared different surgical methods&#xD;
      for adenoidectomy. Usually the parameters for comparison were : surgery time, amount of&#xD;
      bleeding, complications and regrowth rate (ref 2). None of them examined long term clinical&#xD;
      outcome.&#xD;
&#xD;
      The GOLD STANDARD in terms of evaluation of sleep apnea in children is PSG (Polysomnography).&#xD;
      However, due to the availability and cost of this test, new methods for assessing these&#xD;
      children are studied. Alternatively, some questionnaires were prepared in order to evaluate&#xD;
      obstructive sleep apnea in children. One of these questionnaires is the PEDIATRIC SLEEP&#xD;
      QUESTIONNARE that contains 22 easy to understand questions which should be answered by&#xD;
      YES/NO/IDONT KNOW (ref 3). A result of &gt;0.33 (more than 7 questions answered by yes) should&#xD;
      be taken to PSG . In the year 2000 the same group that created the questionnaire published an&#xD;
      article in the Sleep Medicine Journal that showed high sensitivity and high validity for&#xD;
      sleep apnea diagnosis. The conclusion was that this questionnaire can replace the PSG in&#xD;
      clinical trials (ref 3). In 2007 the same group released another study which demonstrates the&#xD;
      advantage of the questionnaire compared to PSG evaluation in terms of cognitive and&#xD;
      behavioral morbidity of in OSA (Obstructive Sleep Apnea) (ref 4).&#xD;
&#xD;
      In this study the investigators aim to investigate whether there any advantages using SUCTION&#xD;
      DIATHERMY in adenoidectomy versus Cold method adenoidectomy in terms of sleep questionnaire&#xD;
      score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric Sleep Questionnaire scores</measure>
    <time_frame>a month and a year following the surgery</time_frame>
    <description>changes in the Pediatric Sleep Questionnaire scores compared to baseline (before the surgery)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intra-operative complications</measure>
    <time_frame>intraoperative</time_frame>
    <description>complications during the surgery (i.e. bleeding)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative complications</measure>
    <time_frame>up till a month following the surgery</time_frame>
    <description>complications following the surgery (i.e. fever, bleeding)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Adenoid; Growth</condition>
  <arm_group>
    <arm_group_label>cold adenoidectomy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - cold method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hot method adenoidectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - hot method</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>adenoidectomy - cold method</intervention_name>
    <description>a surgery for adenoid removal or reduction under general anesthesia using surgical curretes</description>
    <arm_group_label>cold adenoidectomy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>adenoidectomy - hot method</intervention_name>
    <description>a surgery for adenoid removal or reduction under general anesthesia using suction diathermy</description>
    <arm_group_label>hot method adenoidectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 1 to 15&#xD;
&#xD;
          2. Children with obstructive sleep apnea&#xD;
&#xD;
          3. Children whose parents agreed to be enrolled in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children who underwent adenoidectomy in the past&#xD;
&#xD;
          2. Refusal for participation by the parent.&#xD;
&#xD;
          3. a diagnosis of malignancy&#xD;
&#xD;
          4. Unable to adhere follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Arie Gordin, MD</investigator_full_name>
    <investigator_title>Head of pediatric otolaryngology division</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT03760341
org study id: 0087-14-RMB
nct id: NCT03760341
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Adenoidectomy is one of the most common procedures done by the otolaryngologist.
      The procedure can be performed using the cold method (mainly adenoid curettes) or the hot
      method (suction diathermy). Both techniques have similar intra and post-operative outcomes.
      However, the long term clinical outcome in improving the sleep disorder symptoms was never
      compared between the two methods.

      Objective: To compare the advantages using the hot method compared to the cold method
      adenoidectomy in the long term follow up.

      Methods: A prospective, randomized, single blinded study of children undergoing adenoidectomy
      between the years 2014-2017. Patients were randomized to hot or cold adenoidectomy
      techniques. The primary outcome was change of the Pediatric Sleep Questionnaire Score (PSQ)
      scores one month and one year after surgery.
The most common cause of sleep disordered breathing in children is enlargement of the
      adenoids and tonsils relative to the upper airway space.

      Obstructive sleep apnea could cause pulmonary and cardiovascular complications, and could
      influence negatively the l quality of life of the child. Adenoidectomy with or without
      tonsillectomy is one of the most common procedures done by the otolaryngologist.
      Adenoidectomy is performed under general anesthesia .The main indications for the procedure
      include adenoid hypertrophy, obstructive sleep apnea, chronic adenoiditis, and chronic otitis
      media (ref 1).

      Historically recommended instrumentation for performing adenoidectomy has varied from a steel
      nail, cutting or biting forceps, adenotomes and adenoid curettes.

      In 2009 the National institute for health and clinical excellence has published guidelines on
      the use of suction diathermia adenoidectomy which showed that the method is as effective as
      or even more than cold method, the method is considered more secure with some advantage in
      terms of complications of adenoidectomy2, Several studies compared different surgical methods
      for adenoidectomy. Usually the parameters for comparison were : surgery time, amount of
      bleeding, complications and regrowth rate (ref 2). None of them examined long term clinical
      outcome.

      The GOLD STANDARD in terms of evaluation of sleep apnea in children is PSG (Polysomnography).
      However, due to the availability and cost of this test, new methods for assessing these
      children are studied. Alternatively, some questionnaires were prepared in order to evaluate
      obstructive sleep apnea in children. One of these questionnaires is the PEDIATRIC SLEEP
      QUESTIONNARE that contains 22 easy to understand questions which should be answered by
      YES/NO/IDONT KNOW (ref 3). A result of >0.33 (more than 7 questions answered by yes) should
      be taken to PSG . In the year 2000 the same group that created the questionnaire published an
      article in the Sleep Medicine Journal that showed high sensitivity and high validity for
      sleep apnea diagnosis. The conclusion was that this questionnaire can replace the PSG in
      clinical trials (ref 3). In 2007 the same group released another study which demonstrates the
      advantage of the questionnaire compared to PSG evaluation in terms of cognitive and
      behavioral morbidity of in OSA (Obstructive Sleep Apnea) (ref 4).

      In this study the investigators aim to investigate whether there any advantages using SUCTION
      DIATHERMY in adenoidectomy versus Cold method adenoidectomy in terms of sleep questionnaire
      score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Pediatric Sleep Questionnaire scores
time frame: a month and a year following the surgery
description: changes in the Pediatric Sleep Questionnaire scores compared to baseline (before the surgery)
measure: intra-operative complications
time frame: intraoperative
description: complications during the surgery (i.e. bleeding)
measure: post-operative complications
time frame: up till a month following the surgery
description: complications following the surgery (i.e. fever, bleeding)
arm group label: cold adenoidectomy group
arm group type: Active Comparator
description: this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - cold method
arm group label: hot method adenoidectomy
arm group type: Active Comparator
description: this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - hot method
intervention type: Procedure
intervention name: adenoidectomy - cold method
description: a surgery for adenoid removal or reduction under general anesthesia using surgical curretes
arm group label: cold adenoidectomy group
intervention type: Procedure
intervention name: adenoidectomy - hot method
description: a surgery for adenoid removal or reduction under general anesthesia using suction diathermy
arm group label: hot method adenoidectomy
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Arie Gordin, MD
investigator title: Head of pediatric otolaryngology division
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No