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CTRI Number  CTRI/2021/12/038620 [Registered on: 14/12/2021] Trial Registered Prospectively
Last Modified On: 03/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the results of two techniques (single and double flap technique) of endoscopic tympanoplasty - an ear surgery. 
Scientific Title of Study   Endoscopic Single Flap versus Double Flap Tympanoplasty: a Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shafaat Ahmad 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital, New Delhi 
Address  Department of ENT and Head & Neck Surgery, Room 328, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110002.

Central
DELHI
110002
India 
Phone  091-9718921772  
Fax    
Email  ent.shafaatahmad.2020@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Meher 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi 
Address  Room no 328, Department of ENT and Head & Neck Surgery, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110002.

Central
DELHI
110002
India 
Phone  091-9968894343  
Fax    
Email  ravimeher@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shafaat Ahmad 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital, New Delhi 
Address  Department of ENT and Head & Neck Surgery, Room 328, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110002.

Central
DELHI
110002
India 
Phone  091-9718921772  
Fax    
Email  ent.shafaatahmad.2020@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak Hospital, G.I.P.M.E.R. & G.N.E.C., New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated Lok Nayak Hospital GIPMER GNEC New Delhi 
Address  Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, New Delhi, Delhi 110002 
Type of Sponsor  Government medical college 
 
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 
Shafaat Ahmad  Department of ENT and Head & Neck Surgery, Maulana Azad Medical College and Lok Nayak Hospital  Department of ENT and Head & Neck Surgery, Room 328, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI 		 091-9718921772

ent.shafaatahmad.2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoscopic Double tympanomeatal flap tympanoplasty  •Posterior tympanomeatal flap will be elevated like, in group A. •Then, the anterior tympanomeatal flap will be elevated by giving a horizontal incision 3-6 mm lateral to the anterior portion of the annulus at 3 o clock. The canal skin and anterior annular ring will be elevated medially with a Rosen Needle. •Care will be taken to preserve the integrity of the annular ring while doing so. •The previously harvested fascia graft will be trimmed to appropriate size for full coverage of the perforation and tailored to have an anterior tip. •The trimmed fascia graft will be placed into the middle ear through the posterior flap and draped properly to cover the TM perforation. •The anterior tip will be picked up with the right-angle hook and pulled through the tunnel underneath the tympanic annulus, and out through the anterior tympanomeatal flap skin incision. •The anterior tympanomeatal flap followed by the posterior tympanomeatal flap will be placed back down into their native positions respectively. •Final position of the graft will be checked for after fixation with the margins of the tympanomeatal flap in the entire course. •Rest of the post-op care will remain the same as with the single tympanomeatal flap technique.  
Comparator Agent  Endoscopic Single tympanomeatal flap tympanoplasty  •The procedure will begin with a transcanal endoscopic examination of the TM. •A temporalis fascia graft will be harvested in standard fashion, pressed, and then dried. •The margins of the perforation will be freshened. •A posterior canal wall incision will be made 6-8 mm from annulus from 6 to 12 o’clock, then posterior tympanomeatal flap will be elevated with the posterior tympanic annulus to enter middle ear space. •Tympanic membrane will be dissected from handle of malleus and status of the middle ear and ossicular chain will be examined. •The middle ear will then be packed with gel foam followed by antibiotic soaked ribbon gauze. •The previously harvested fascia graft will be trimmed to appropriate size for full coverage of the perforation and placed over handle of malleus, below remnant of tympanic membrane and draped properly. •The posterior tympanomeatal flap will then be laid back down in native position followed by antibiotic ear pack and a standard ear pressure dressing will be applied for the first 24 hours and then removed. •The outer canal packing will be removed in 1 week at the first post-operative visit and otoscopic evaluation will be done to assess the graft intactness. •Endoscopic follow up evaluation and follow up Pure Tone Audiometry (PTA) will be done after 3 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age group >18 years & ≤ 60 years
2.Grade III and Grade IV tympanic membrane perforations.
3.Dry ear
4.Good cochlear reserve
 
 
ExclusionCriteria 
Details  1.Active mucosal disease
2.Atticoantral disease
3.Revision ear surgery
4.Active nasopharynx or sinus infection
5.Extensive tympanosclerosis
6.Suspected ossicular involvement
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Graft uptake rate at 3 months after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.  3 months after the intervention (surgery) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in air conduction- bone conduction gap (AB gap) after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.  3 months after the intervention(surgery) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/12/2021 
Date of Study Completion (India) 31/07/2022 
Date of First Enrollment (Global)  20/12/2021 
Date of Study Completion (Global) 31/07/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Submitted for publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 

Background and objectives: This study is aimed to compare the outcomes of the two techniques (endoscopic single flap tympanoplasty- ESFT versus endoscopic double flap tympanoplasty - EDFT) of endoscopic tympanoplasty for repairing large tympanic membrane (TM)perforations with limited anterior remnant.

Subjects and methods: In this randomised controlled trial, forty patients with large sized TM perforations were included and randomised in the ESFT and EDFT arms with twenty patients in each group. The ESFT group underwent conventional endoscopic transcanal tympanoplasty using temporalis fascia while the EDFT group underwent the double flap technique of endoscopic transcanal tympanoplasty with an additional anterior flap, outcomes were compared.

Results: Graft success rate was 85% (17/20 cases) in the ESFT group and 90%(18/20 cases) in the EDFT group. The ABG improvement median with interquartile range(IQR) was 5 dB (3.12 dB-10 dB) in the ESFT group and 8.75 dB (5dB-11.87 dB) in the EDFT group. The difference was not statistically significant.

Conclusions: When EDFT versus ESFT was attempted endoscopically in our study, there was no statistically significant difference in the graft success rate or hearing gain. Moreover, there was longer operative time and need for an extra incision while raising the anterior flap. This lack of statistically significant results in our study may be since the study has a very small sample size. Whether the same conclusion is reproducible needs to be further explored by a large size randomised controlled trial. 


 
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