| CTRI Number |
CTRI/2017/08/009199 [Registered on: 01/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of The Efficacy of Endoscopic versus Microscopic Myringoplasty(surgical techniques) in Management of ear drum Perforations: A Randomized Clinical Trial. |
|
Scientific Title of Study
|
Comparison of The Efficacy of Endoscopic versus Microscopic Myringoplasty in Management of Pars Tensa Perforations: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Chandra Shekar Reddy |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Department of ENT
Jipmer
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9989303942 |
| Fax |
|
| Email |
dr.rcsreddy91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof SK Saxena |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of ENT
Jipmer
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442527018 |
| Fax |
|
| Email |
reddchandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Chandra Shekar Reddy |
| Designation |
Junior resident |
| Affiliation |
|
| Address |
Department of ENT
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9989303942 |
| Fax |
|
| Email |
dr.rcsreddy91@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of ENT
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| R Chandra Shekar Reddy |
JIPMER |
Department of ENT
JIPMER
Pondicherry
Pondicherry
PONDICHERRY |
9989303942
dr.rcsreddy91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic suppurative otitis media tubotympanic type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic myringoplasty |
Assessment of hearing outcomes, graft uptake and post operative complications after procedure. |
| Comparator Agent |
Microscopic Myringoplasty |
Assessment of hearing outcomes, graft uptake and post operative complications after procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed cases of CSOM TTD with pars tensa perforation and conductive hearing loss in the age group of 18 to 50 years of both sex in JIPMER hospital |
|
| ExclusionCriteria |
| Details |
1. Patients with active discharge from middle ear
2 CSOM of attico antral type
3. Patients with otitis externa
4. Patients with sensorineural hearing loss or mixed type hearing loss
5 Patients with abnormalities in ossicular chain
6 Patients with nasal allergy, bleeding diathesis, diabetes, hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hearing outcome in both the groups in the treatment of CSOM TTD |
Pre operative
8 weeks
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare graft uptake between both the groups |
8 weeks
3 months |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/09/2016 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comparision of the efficacy of endoscopic versus Microscopic Myringoplasty in the management of pars tensa perforations : A Randomised clinical trial. Closure of tympanic membrane perforations in the pars tensa region in a case of CSOM tubo tympanic type disease is known as myringoplasty. Various advancements in this surgery are now available and here we compare 2 novel procedures done for the treatment of pars tensa perforations. Hearing outcomes after both types of surgery will be assessed as the primary outcome and graft uptake will be the secondary outcome of this study. Block randomization will be followed. Data collection will be done and patient will be followed up post operatively at 8 weeks and 3 months for hearing assessment and graft uptake.Unpaired t test will be used to compare hearing outcomes between both the groups.Graft uptake will be statistically assessed by the chi square test or fischers test. This study aims to show both the techniques used for pars tensa perforation repair and advantages and disadvantages of each. |