NCT00271778

Brief Summary

Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.

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 below P25 for phase_3

Timeline
Completed

Started Jul 2003

Typical duration for phase_3

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

Study Start

First participant enrolled

July 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 4, 2006

Status Verified

December 1, 2005

First QC Date

January 3, 2006

Last Update Submit

January 3, 2006

Conditions

Chronic Otitis MediaTubotympanic Disease

Keywords

Otitis media suppurativesurgery ear

Outcome Measures

Primary Outcomes (4)

  • Pure tone audiometry

  • Impedance audiometry

  • Otoendoscopy

  • External ear canal dimensions

Interventions

mastoidotympanoplasty and tympanoplastyPROCEDURE

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ENT, KIMS

Hubli, Karnataka, 580021, India

Location

MeSH Terms

Conditions

Otitis Media, Suppurative

Interventions

Tympanoplasty

Condition Hierarchy (Ancestors)

SuppurationInfectionsOtitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Vikram K Bhat, MS, DNB.

    Karnataka Institute of Medical Sciences, Hubli, India

    PRINCIPAL INVESTIGATOR

  • Khaja Naseeruddin, MS, DLO.

    Vijayanagar Institute of Medical Sciences, Bellary, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

July 1, 2003

Study Completion

June 1, 2006

Last Updated

January 4, 2006

Record last verified: 2005-12

Locations

IN(1)