NCT03475329

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

March 12, 2018

Last Update Submit

January 21, 2019

Conditions

Obstructive Sleep Disordered Breathing

Keywords

pediatric obstructive sleep disordered breathing-partial tonsillectomy -unilateral complete tonsillectomy -adenoidectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative pain assessed by cries scale

    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

Study Arms (2)

adenoidectomy with bilateral partial tonsillectomy

Other: adenotonsillectomy

adenoidectomy with complete unilateral tonsillectomy

Other: adenotonsillectomy

Interventions

adenotonsillectomyOTHER

adenoidectomy with bilateral tonsillectomy versus adenoidectomy with unilateral complete tonsillectomy

adenoidectomy with bilateral partial tonsillectomyadenoidectomy with complete unilateral tonsillectomy

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital.The study will be carried on 60 consecutive cases.

You may qualify if:

  • Age: 1-3 yeas.
  • Diagnosed to have Obstructive Sleep-Disordered Breathing (OSDB) due to adenotonsillar enlargement confirmed by flexible nasoendoscopic assessment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit

Asyut, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the principal investigator

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 23, 2018

Study Start

April 1, 2018

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

EG(1)