Obstructive Sleep Disordered Breathing Clinical Trial
Official title:
Adenoidectomy With Bilateral Partial Tonsillectomy Versus Adenoidectomy With Unilateral Complete Tonsillectomy in Treatment of Children With Obstructive Sleep-Disordered Breathing :Acomparative Study
The aim of the study is to evaluate adenoidectomy with bilateral partial tonsillectomy compared with adenoidectomy with classical unilateral complete tonsillectomy for management of pediatric Obstructive Sleep-Disordered Breathing (OSDB) in terms of efficacy of the technique and reducing postoperative complications.
Tonsillectomy is one of commonly performed pediatric otorhinolaryngology surgeries.
The two main indications of tonsillectomy in children include recurrent tonsillitis and
Obstructive Sleep-Disordered Breathing (OSDB); including obstructive sleep apnea and upper
airway resistance syndrome.
Total tonsillectomy means total removal of the tonsillar tissue with the tonsillar capsule.
The main drawbacks of tonsillectomy are the potential for serious postoperative bleeding,
postoperative pain, eating and drinking difficulties, and reduced immune function in the
early stages after the operation. Partial tonsillectomy (intracapsular tonsillectomy,
subtotal tonsillectomy) means subtotal removal of tonsillar tissue, leaving a margin of
tissue on the tonsillar capsule . In contrast to complete tonsil removal, Partial
tonsillectomy does not violate the capsule, and leaves lymphoid tissue as a protective tissue
on the pharyngeal muscle layer thus preserving of the connective tissue capsule and
pharyngeal muscles. This diminishes the direct and indirect trauma during an intraoperative
procedure and the inflammation due to secondary infection during the postoperative period.
Recently, children with OSDB have benefited from the less invasive partial tonsillectomy with
less pain, equivalent or easier recovery, better food intake, and maintain the immunological
function of the tonsils, while being as effective as tonsillectomy for resolving upper-airway
obstructive symptoms.
Many studies have evaluated the outcomes of the two techniques, but uncertainty remains with
regard to the efficacy, complications and long term outcomes. Some studies have reported the
recurrence of obstructive symptoms due to regrowth of the remaining tonsillar tissue. Thus,
it is important to evaluate Partial tonsillectomy comprehensively, especially paying
attention to short-term and long-term results.
Over the last years, unilateral complete tonsillectomy (usually combined with adenoidectomy)
was the most commonly utilized procedure for treatment of pediatric obstructive
sleep-disordered breathing below the age of four years old in Otorhinolaryngology Department,
Assiut University
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01918007 -
Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study
|
N/A | |
| Withdrawn |
NCT00519402 -
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing
|
N/A |