Trial Outcomes & Findings for Comparison of Sleep Study Results After Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy (NCT NCT00887471)

Results Overview

Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Baseline and 4 years

Results posted on

2014-02-10

Participant Flow

Review of surgical case logs identified 45 patients with positive polysomnography (PSG) (laboratory-based, home or nap)who had undergone PITA and 101 with positive PSG who had undergone T\&A.

Of these 15 PITA patients entered and completed the study and 15 matched T\&A patients entered and completed the study.

Participant milestones

Participant milestones
Measure	Children Who Underwent PITA Children who underwent partial intracapsular tonsillectomy and adenoidectomy.	Children Who Underwent T&A Children who underwent total tonsillectomy and adenoidectomy.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Sleep Study Results After Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children Who Underwent PITA n=15 Participants Children who underwent partial intracapsular tonsillectomy and adenoidectomy.	Children Who Underwent T&A n=15 Participants Children who underwent total tonsillectomy and adenoidectomy.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.33 years STANDARD_DEVIATION 3.65 • n=5 Participants	6.15 years STANDARD_DEVIATION 3.29 • n=7 Participants	5.74 years STANDARD_DEVIATION 3.44 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 years

Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point

Outcome measures

Outcome measures
Measure	Children Who Underwent PITA n=15 Participants Children who underwent partial intracapsular tonsillectomy and adenoidectomy.	Children Who Underwent T&A n=15 Participants Children who underwent total tonsillectomy and adenoidectomy.
Median Change in Apnea-hypopnea Index (AHI)	3.8 events per hour of sleep Standard Deviation 8.5	8.0 events per hour of sleep Standard Deviation 18.7

SECONDARY outcome

Timeframe: Baseline and 4 years

Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study

Outcome measures

Outcome measures
Measure	Children Who Underwent PITA n=15 Participants Children who underwent partial intracapsular tonsillectomy and adenoidectomy.	Children Who Underwent T&A n=15 Participants Children who underwent total tonsillectomy and adenoidectomy.
Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5	5 participants	4 participants

Adverse Events

Children Who Underwent PITA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children Who Underwent T&A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nira A Goldstein, MD

SUNY Downsate Medical Center

Phone: 718-270-1638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place