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Adeno-tonsillectomy in Treatment of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03475329
Recruitment Status : Not yet recruiting
First Posted : March 23, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Christina Farag Zaki, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Disordered Breathing Other: adenotonsillectomy

Detailed Description:

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


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adenoidectomy With Bilateral Partial Tonsillectomy Versus Adenoidectomy With Unilateral Complete Tonsillectomy in Treatment of Children With Obstructive Sleep-Disordered Breathing :Acomparative Study
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Group/Cohort Intervention/treatment
adenoidectomy with bilateral partial tonsillectomy Other: adenotonsillectomy
adenoidectomy with bilateral tonsillectomy versus adenoidectomy with unilateral complete tonsillectomy

adenoidectomy with complete unilateral tonsillectomy Other: adenotonsillectomy
adenoidectomy with bilateral tonsillectomy versus adenoidectomy with unilateral complete tonsillectomy




Primary Outcome Measures :
  1. postoperative pain assessed by cries scale [ Time Frame: two weeks ]
    The CRIES scale is used for infants > than or = 38 weeks of gestation. Characteristics of crying, oxygen requirement, changes in vital signs, facial expression, and sleep state are scored. A maximal score of 10 is possible. If the CRIES score is > 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital.The study will be carried on 60 consecutive cases.
Criteria

Inclusion Criteria:

  • • Age: 1-3 yeas.

    • Diagnosed to have Obstructive Sleep-Disordered Breathing (OSDB) due to adenotonsillar enlargement confirmed by flexible nasoendoscopic assessment.

Exclusion Criteria:

  • • Any associated medical comorbidity that contraindicates general anesthesia.

    • Children having other causes for OSDB (e.g. obesity, Down syndrome, craniofacial abnormalities, neuromuscular disorders, sickle cell disease, or mucopolysaccharidoses).
    • Refusal of enrollment in the research by care givers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475329


Contacts
Contact: Ahmed Aboulwafa Abdul Jaleel, prof .dr 01060871584 ahmadabeg@yahoo.com
Contact: Ahmed Hamed Mohamed Monib, lecturer 01001161152 ahmedmonib.orl@gmail.com

Sponsors and Collaborators
Assiut University

Responsible Party: Christina Farag Zaki, the principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03475329     History of Changes
Other Study ID Numbers: AITOOSA
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christina Farag Zaki, Assiut University:
pediatric obstructive sleep disordered breathing-partial tonsillectomy -unilateral complete tonsillectomy -adenoidectomy

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes