FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/019026 [Registered on: 09/05/2019] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of repair of ear drum with and without full stability of graft  
Scientific Title of Study   A randomized study of type I tympanoplasty with and without stabilization of graft by Anterior Tympanomeatal flap. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhinav Srivastava 
Designation  Associate Professor 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of ENT Room Number 1203 Opposite Suresh Sharma Nagar Pilibhit Bypass Road
Opposite Suresh Sharma Nagar Pilibhit Bypass Road
Bareilly
UTTAR PRADESH
243006
India 
Phone  05812525063  
Fax  05812526152  
Email  drabhinavsrivastava7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhinav Srivastava 
Designation  Associate Professor 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of ENT Room Number 1203 Opposite Suresh Sharma Nagar Pilibhit Bypass Road
Suresh Sharma Nagar Pilibhit Bypass Road
Bareilly
UTTAR PRADESH
243006
India 
Phone  05812525063  
Fax  05812526152  
Email  drabhinavsrivastava7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhinav Srivastava 
Designation  Associate Professor 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Opposite Suresh Sharma Nagar Pilibhit Bypass Road
Pilibhit Bypass Road
Bareilly
UTTAR PRADESH
243006
India 
Phone  05812525063  
Fax  05812526152  
Email  drabhinavsrivastava7@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital, Pilibhit bypass Road Bareilly 
 
Primary Sponsor  
Name  Dr Abhinav Srivastava 
Address  Associate Professor Department of ENT Rohilkhand Medical College and Hospital, Bareilly 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhinav Srivastava  Rohilkhand Medical College and Hospital, Bareilly  Room Number 1203, Department of ENT, Rohilkhand Medical College and Hospital, Pilibhit bypass Road,
Bareilly
UTTAR PRADESH 		 05812525063
05812526152
info@rmcbareilly.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) of Rohilkhand Medical College and Hospital, Bareilly  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H720||Central perforation of tympanic membrane,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anterior Tympanomeatal Flap  Stabilizing the graft by flap made in the anterior part of external auditory canal named as Anterior Tympanomeatal Flap 
Comparator Agent  Conventional method of type 1 tympanoplasty  To compare the results of outcome of type 1 tympanoplasty with stabilization of graft with anterior tympanomeatal flap with the comparator group that underwent type 1 tympanoplasty by conventional method. Outcome will be evaluated in terms of graft uptake and hearing gain at 3 and 6 months 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patient of inactive mucosal disease,
Patients 12 years and above,
Patients with conductive hearing loss less than 50 dB
 
 
ExclusionCriteria 
Details  Patients less than 12 years,
Patients with previous history of ear surgery, Patients with sensory neural hearing loss,
Patients with congenital anomaly
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To see the outcome of surgery in terms of graft uptake and hearing gain in the two groups at 3 and 6 months  3 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To see the blunting of anterior tympanomeatal angle and its affect on hearing   3 and 6 months 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/05/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1. Pradeep P, Abhimanyu A, Priti L. Circumferential Elevation of Tympanomeatal Flap: A Novel technique for subtotal an Anterior perforation Closure. Ann Otolaryngol Rhinol. 2015;2(7):1052. 2. Mokhtarinejad F, Okhovat SA, Barzegar F. Surgical and Hearing results of the circumferential sub annular grafting technique in tympanoplasty: A randomized clinical study. Am J Otolaryngol. 2012; 33:75-9  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   All the cases of inactive mucosal type of Chronic Suppurative Otitis Media(CSOM) will be divided into two groups based on lottery method of randomization. one group A will undergo type 1 tympanoplasty by conventional method and the other group B will be done by stabilization of graft by anterior tympanomeatal flap. The result will be evaluated in the two groups in terms of graft uptake and hearing gain at 3 and 6 months. 
Close