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CTRI Number  CTRI/2024/07/070573 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
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 two techniques of microsurgery for fixing hole in the eardrum which are not healing on their own 
Scientific Title of Study   A Comparative Study Between Interlay and Underlay in Type 1 Tympanoplasty 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudip Kumar Nath 
Designation  Post Graduate Trainee 
Affiliation  Silchar Medical College and Hospital  
Address  Department of Otorhinolaryngology, Silchar Medical College and Hospital, Ghungoor, Silchar, Cachar

Cachar
ASSAM
788014
India 
Phone  9706642040  
Fax    
Email  nathsud@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kripamoy Nath 
Designation  Associate Professor 
Affiliation  Silchar Medical College and Hospital 
Address  Department of Otorhinolaryngology, Silchar Medical College and Hospital, Ghungoor, Silchar, Cachar

Cachar
ASSAM
788014
India 
Phone  9435074250  
Fax    
Email  krips.nat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kripamoy Nath 
Designation  Associate Professor 
Affiliation  Silchar Medical College and Hospital 
Address  Department of Otorhinolaryngology, Silchar Medical College and Hospital, Ghungoor, Silchar, Cachar

Cachar
ASSAM
788014
India 
Phone  9435074250  
Fax    
Email  krips.nat@gmail.com  
 
Source of Monetary or Material Support  
Silchar Medical College and Hospital, Ghungoor, Silchar, District- Cachar, State- Assam, Pin- 788014 
 
Primary Sponsor  
Name  Dr Sudip Kumar Nath 
Address  Department of Otorhinolaryngology, Silchar Medical College and Hospital, Ghungoor, Silchar, Dist-Cachar, State-Assam,Pin-788014 (India) 
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 Sudip Kumar Nath  Silchar Medical College and Hospital  New SMCH Building ,Department of Otorhinolaryngology, 2nd Floor, SMCH, Ghungoor, Silchar, Assam- 788014
Cachar
ASSAM 		 9706642040

nathsud@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Silchar Medical College and Hospital  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  Interlay Type 1 Tympanoplasty  In interlay procedure, the graft is sandwiched between the canal wall and the remnant of tympanic membrane mucosa on one side, and tympanomeatal flap with squamous epithelial and fibrous layers on the other side.  
Comparator Agent  Underlay type 1 tympanoplasty  In underlay type 1 tympanoplasty the graft is placed medial to the tympanic membrane remnant and handle of malleus. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cases of chronic otitis media with inactive mucosal disease with a small to large central perforation and pure conductive hearing loss were included in the study. Active mucosal disease under local and systemic antibiotic coverage for 7 days. Both males and females in the age group of 10 to 60 years of age were included in the study. 
 
ExclusionCriteria 
Details  1.Patients with squamosal disease
2.Patients with ossicular discontinuity/ necrosis
3.Patients below 10 years and above 60 years were excluded from the study.
4.Patients with active focus of infection in throat, nose and oral cavity
5.Patients who fail to follow-up for at least 3 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To analyse and compare the outcomes of interlay and underlay techniques in type 1 tympanoplasty in terms of graft uptake and hearing improvement.  1 month, 3 months and 6 months after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To find the incidence of CSOM in 10- 60yrs age group  1 yr 
Expected findings and complications after type 1 tympanoplasty  1 yrs 
To find out the etiological factors of mucosal type of COM  1 yr 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   24/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chronic suppurative otitis media (CSOM) has a major impact on the social life of a person in the form of hearing disability. The discharge from the ear is also troublesome causing great discomfort to the patient. The mucosal type of CSOM can be treated surgically by tympanoplasty. It is a procedure done to repair the defect in the tympanic membrane after eradicating all the disease in the middle ear cleft with or without reconstruction of ossicular chain . The classification is based on the placement of graft in relation to the remnant tympanic membrane as:

(a) Underlay technique—graft is placed medial to the mucosal layer.

(b) Overlay technique—graft is placed lateral to the fibrous layer of tympanic membrane after elevating all squamous epithelium.

(c) Interlay technique—graft is placed between the fibrous layer and the endothelial (mucosal) layer of the drum remnant.

In overlay technique there are chances of anterior canal wall blunting, lateralisation of the graft, formation of epithelial pearls, excessive membrane thickness, and longer duration of healing and increased risk of iatrogenic cholesteatoma . The disadvantages of underlay technique are that the middle ear space is reduced, there are chances of medialisation of the graft , less suitable for large anterior perforations  and longer healing time.

In interlay technique the graft is supported medially by the mucosal layer and laterally by the fibro squamous layer thus contributing to the following advantages:

a)     There is no blunting, as the anterior sulcus is skin lined.

b)    Interlay is more physiological and anatomical compared to underlay and overlay

c)     No lateralisation, as the graft is placed medial to mallets and fibro-squamous layer.

d)    No epithelial cyst formation.

e)     No medialisation.

f)     Can clear tympanosclerosis from anterosuperior quadrant easily.

g)    Myringitis due to endothelium overgrowth on the graft is avoided.

h)    No reduction in middle ear space.

The present study is undertaken to evaluate the outcome of type 1 interlay tympanoplasty in comparison to underlay techniques. The objectives are to evaluate the graft take up rate, to compare the hearing improvement and to study the complications associated with interlay technique and underlay technique.


 
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