Chronic Otitis MediaPhase 3NCT00271778
A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media
A Phase 3 study testing mastoidotympanoplasty and tympanoplasty in people with Chronic Otitis Media and Tubotympanic Disease, run by Karnataka Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Chronic Otitis Media, Tubotympanic Disease
- What is being tested?
- mastoidotympanoplasty and tympanoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2003to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria:Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain -
Exclusion Criteria:1. atticoantral otitis media 2. Specific otitis media 3. Sensorineural hearing loss 4. Fixed/Dislocated ossicular chain 5. Uncorrectable disease focus in nose/throat 6. Chronic otitis media in active phase 7. Chronic otitis media with complications 8. Extensive unresectable tympanosclerosis
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
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.
Read the detailed description
Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 [30 cases in each group]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3.
Outcomes:
- Improvement of hearing
- Closure of tympanic perforation
- Recurrence of disease
- external ear canal stenosis
Tools for measurement of outcomes [before and after surgery]:
- Pure tone audiometry
- Impedance audiometry
- Otoendoscopy
- External ear canal dimensions
- Conditions
- Chronic Otitis Media, Tubotympanic Disease
- Being tested
- mastoidotympanoplasty and tympanoplasty
- Keywords
- Otitis media suppurative, surgery ear
- Medical subject headings
- Otitis Media, Suppurative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mastoidotympanoplasty and tympanoplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone audiometry
Impedance audiometry
Otoendoscopy
External ear canal dimensions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startJul 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Karnataka Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Vikram K Bhat, MS, DNB., Principal investigator, Karnataka Institute of Medical Sciences, Hubli, IndiaKhaja Naseeruddin, MS, DLO., Study director, Vijayanagar Institute of Medical Sciences, Bellary, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271778
- Sponsor's protocol ID
- M06b/2003-04
- Status last verified
- Dec 2005
- First submitted
- 3 Jan 2006
- Last updated
- 4 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
- ClinicalTrials.gov ID
- NCT00271778
- Acronym / sponsor ID
- M06b/2003-04
- Conditions
- Chronic Otitis Media, Tubotympanic Disease
- Keywords
- Otitis media suppurative, surgery ear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Karnataka Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Jun 2006
- First posted
- 4 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 [30 cases in each group]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3.
Outcomes:
- Improvement of hearing
- Closure of tympanic perforation
- Recurrence of disease
- external ear canal stenosis
Tools for measurement of outcomes [before and after surgery]:
- Pure tone audiometry
- Impedance audiometry
- Otoendoscopy
- External ear canal dimensions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mastoidotympanoplasty and tympanoplasty | Procedure or surgery | – |
Primary outcome
Pure tone audiometry
Impedance audiometry
Otoendoscopy
External ear canal dimensions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikram K Bhat, MS, DNB. principal investigator
Karnataka Institute of Medical Sciences, Hubli, India
Khaja Naseeruddin, MS, DLO. study director
Vijayanagar Institute of Medical Sciences, Bellary, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mastoidotympanoplasty and tympanoplasty in people with Chronic Otitis Media and Tubotympanic Disease, run by Karnataka Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone audiometry. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2006.