Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients
Condition: Obstructive Sleep Apnea; Adenoid; Growth
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): adenoidectomy - cold method; adenoidectomy - hot method
Intervention type(s): Procedure; Procedure
Intervention description(s): a surgery for adenoid removal or reduction under general anesthesia using surgical curretes; a surgery for adenoid removal or reduction under general anesthesia using suction diathermy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment