Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00286

2 Trial Registration Date

2011-05-07

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

nil

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Kwan Ka Chung Peter

ii Address

Department of ENT, Pamela Youde Nethersole Eastern Hosptial. 3 Lok Man Road, Chai Wan. HK

iii Phone

25956111

iv Email

kkc141@ha.org.hk

v Affiliation

Department of ENT, Pamela Youde Nethersole Eastern Hosptial

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Kwan Ka Chung Peter

ii Address

Department of ENT, Pamela Youde Nethersole Eastern Hosptial. 3 Lok Man Road, Chai Wan. HK

iii Phone

25956111

iv Email

kkc141@ha.org.hk

v Affiliation

Department of ENT, Pamela Youde Nethersole Eastern Hosptial

vi Country

9 Official Scientific Title of the Study

A prospective study of the effectiveness of incisionless office remedial myringoplasty with preserved temporalis fascia in early post-myringoplasty graft failure

10 Public Title

A prospective study of the effectiveness of incisionless office remedial myringoplasty with preserved temporalis fascia in early post-myringoplasty graft failure

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Office remedial myringoplasty

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-03-16

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Perforated tympanic membrane, post-myringoplasty graft failure

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Office remedial myringoplasty

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Once

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients with formal myringoplasty done in PYNEH and found to have a graft defect on follow-up in PYNEH SOPD

ii Exclusion Criteria

- Perforation >3mm
- Patient refusal
- Mentally/ cognitively disabled patients
- Patient unable to cooperate for procedure under microscope
- More than 3 months after the initial operation
- Perforations that are too anterior for incisionless permeatal approach
- Active infection
- No graft preservation

iii Age Minimum

16

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-05-11

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Intact graft at 6 months after office remedial myringoplasty

24 Secondary Outcome

Hearing improvement at 6 months after office remedial myringoplasty

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-07-04

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001357

28 Date of Registration in Primary Registry

2011-06-09

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-06-30