| CTRI Number |
CTRI/2019/02/017654 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare success using wet and dry graft in ear surgery |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMIZED STUDY TO COMPARE SURGICAL OUTCOME USING WET AND DRY TEMPORALIS FASCIA GRAFT IN TYMPANOPLASTY TYPE I |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PC VERMA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
JLN MEDICAL COLLEGE |
| Address |
ROOM NO 70
ENT DEPARTMENT
JLN MEDICAL COLLEGE
Ajmer
ROOM NO 70
ENT DEPARTMENT
JLN MEDICAL COLLEGE
ajmer
Ajmer
RAJASTHAN
335001
India |
| Phone |
9414008278 |
| Fax |
|
| Email |
drpcverma.ent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha sharma |
| Designation |
Resident doctor |
| Affiliation |
JLN Medical college |
| Address |
Room no 70
ENT department
JLN medical college
Room no 70
ENT department
JLN medical college
Ajmer
RAJASTHAN
305001
India |
| Phone |
7597425828 |
| Fax |
|
| Email |
shraddhsharma.sharma7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PC VERMA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
JLN MEDICAL COLLEGE |
| Address |
ROOM NO 70
ENT DEPARTMENT
JLN MEDICAL COLLEGE
Ajmer
ROOM NO 70
ENT DEPARTMENT
JLN MEDICAL COLLEGE
ajmer
RAJASTHAN
335001
India |
| Phone |
9414008278 |
| Fax |
|
| Email |
drpcverma.ent@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JLN MEDICAL COLLEGE |
| Address |
JLN MEDICAL COLLEGE
Ajmer
Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shraddha Sharma |
JLN medical college |
JLN medical college
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN |
7597425828
shraddhsharma.sharma7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,JLN medical college,ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H66||Suppurative and unspecified otitismedia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tympanoplasty type I |
Wet and dry temporalis fascia graft in Tympanoplasty type I |
| Comparator Agent |
wet and dry temporalis fascia graft |
Wet and dry temporalis fascia graft in Tympanoplasty type I |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases of chronic suppurative otitis media tubotympanic type with central perforation having no active discharge for a period of at least 6 weeks. |
|
| ExclusionCriteria |
| Details |
1. Cholesteatoma and granulation
2. Cases of retraction pocket/atelectatic ear.
3. Ossicular chain immobility or defect in ossicles
4. Revision cases
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft. |
To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft. |
The duration of study is of one year. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to evaluate
and compare the surgical outcome of tympanoplasty type I using dry and wet
temporalis fascia graft with following objectives-
Primary
Objective:
1. * Quality of life
measurements for patients with chronic suppurative otitis media using Chronic
Ear Survey questionnaire
2. * To
compare the surgical outcome using dry and wet temporal fascia graft in type 1
tympanoplasty for graft uptake, primary
closure of perforation, recurrent
and residual perforation.
3. * To compare audiological outcome using dry and wet temporal fascia
graft in type 1 tympanoplasty.
Secondary
objective:
1. * To
compare the total operation time and graft placement time using wet
versus dry temporal fascia graft in type 1 tympanoplasty.
2. * To
find out complications after tympanoplasty type I. |