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Clinical Trials/CTRI/2024/03/064494
CTRI/2024/03/064494
Not yet recruiting
Phase 4

A Comparative study of clinical outcomes of adenoidectomy using Microdebrider versus Curette

B Suma1 site in 1 country22 target enrollmentStarted: March 30, 2024Last updated:
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Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
B Suma
Enrollment
22
Locations
1
Primary Endpoint
Improvement in hearing thresholds from pre-intervention study levels measured in
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
3.00 Year(s) to 30.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Inclusion Criteria
  • •Patients belonging to age group of 3-30 years.
  • •Patients with clinical features of adenoid hypertrophy and indicated for adenoidectomy surgery.
  • •Patients fit for surgery.
  • •Patients/ patient’s attendants who are willing to participate in the study.

Exclusion Criteria

  • •Patients/ patient’s attendants who do not give valid informed and written consent.
  • •Patients with cleft palate/ craniofacial deformities
  • •Patients with other causes of hearing loss.

Outcomes

Primary Outcomes

Improvement in hearing thresholds from pre-intervention study levels measured in

Time Frame: before surgery(baseline) and 12 weeks after surgery

dB HL, using pure tone audiometry.

Time Frame: before surgery(baseline) and 12 weeks after surgery

Secondary Outcomes

  • 1. Improvement in tympanogram type: Type B or C to Type A.(2. Comparison of Otoendoscopy findings)

Investigators

Sponsor
B Suma
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

B Suma

Bangalore Medical College and Research Institute

Study Sites (1)

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