Adeno-tonsillectomy in Treatment of Obstructive Sleep Apnea

January 21, 2019 updated by: Christina Farag Zaki, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • ASSUIT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 1 year (Child)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AITOOSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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