| CTRI Number |
CTRI/2024/04/065726 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between endoscopic and microscopic type 1 tympanoplasty. |
|
Scientific Title of Study
|
A Study to compare functional outcomes of Microscopic versus Endoscopic 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. Shivangi Patnecha |
| Designation |
Post graduate junior resident department of otorhinolaryngology and head and neck surgery |
| Affiliation |
All India institute of medical sciences AIIMS, Raipur |
| Address |
Department of ENT and Head and Neck Surgery, C block, ground floor, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9784081123 |
| Fax |
|
| Email |
vp.patnecha98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr. Renu Rajguru |
| Designation |
Head of the department, department of ENT and Head and Neck Surgery |
| Affiliation |
All India institute of medical sciences AIIMS, Raipur |
| Address |
Department of ENT and Head and Neck Surgery, C block, ground floor, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9784081123 |
| Fax |
|
| Email |
renurajguru@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shivangi Patnecha |
| Designation |
Post graduate junior resident department of otorhinolaryngology and head and neck surgery |
| Affiliation |
All India institute of medical sciences AIIMS Raipur |
| Address |
Department of ENT and Head and Neck Surgery, C block, ground floor, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9784081123 |
| Fax |
|
| Email |
vp.patnecha98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr SHIVANGI PATNECHA |
| Address |
Department of ENT and head and neck surgery, C block, ground floor, AIIMS raipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Shivangi Patnecha |
All India institute of medical sciences AIIMS Raipur |
Department of ENT and Head and Neck Surgery, AIIMS, tatibandh, Raipur, Chhattisgarh PIN 492099
Raipur
CHHATTISGARH |
9784081123
vp.patnecha98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 492099(C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic Type 1 tympanoplasty |
In endoscopic tympanoplasty, a zero degree, rigid endoscope with camera and monitor will be used. Temporalis fascia graft will be harvested through a 2–3 cm incision in the hairline above the helix. Margins of the perforation will be freshened, tympanomeatal flap will be elevated, ossicular status to be assessed, middle ear disease clearance to be done. A 30-degree endoscope will be used in cases with overhangs, for close-up and angled views. Medicated Gelfoam would be placed in the middle ear, underlay technique to be used to place the graft and the tympanomeatal flap will be repositioned .Medicated gel foam to be placed in the external auditory canal. Frequent withdrawal of the endoscope to be done to avoid the heat-induced caloric effect or thermal injuries.
Graft uptake and PTA will be done and checked at 3 months and 6 months follow up |
| Comparator Agent |
Microscopic Type 1 tympanoplasty |
All of the conventional microscopic tympanoplasties would be performed using Carl Zeiss Microscope via the postauricular approach with post-aural William Wilde’s incision. Temporalis fascia graft will be harvested, then posterior meatotomy would be done, margins of the perforation to be freshened, canalplasty to be done whenever required, tympanomeatal flap will be elevated, ossicular status to be assessed, middle ear disease clearance will be done, medicated Gel foam to be placed in the middle ear and underlay technique to be used to place the graft and secured by doing anterior tucking and the tympanomeatal flap will be repositioned. Medicated gel foam will be placed in the external auditory canal and wound closure to be done. The Mastoid dressing to be done and advise would be given accordingly.
Graft uptake and PTA will be done and checked at 3 months and 6 months follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of COM mucosal in age group 18-65 yrs, with Central perforations , consenting for surgery. |
|
| ExclusionCriteria |
| Details |
-Pregnant patients,smoker, known diabetic, any other comorbidities
-COM squamosal.
-Large Central perforation, subtotal or total perforations
-Patient with Active ear discharge.
- Patient with suspected ossicular discontinuity or fixation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
We hope to get – Good success rate after endoscopic Tympanoplasty in terms of graft uptake and hearing improvement .
Less intraoperative and post operative pain. |
Follow up at 3 months and 6 months period after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Tympanoplasty refers to any operation involving reconstruction of the tympanic membrane and/or the ossicular chain after eradication of disease. The prevalence of Otitis media varies widely and causes a serious burden of illness globally. Chronic Suppurative Otitis Media (CSOM) accounts for a global burden of 65-330 million individuals with draining ears, 60% of whom suffer from significant hearing impairment. Endoscopes make it possible to address the target pathology transcanal, while minimizing dissection of normal tissue done purely for exposure, leading to the evolution of minimally-invasive ear surgery and reducing morbidity. As there are very few studies showing data of central india about endoscopic tympanoplasty, therefore we are doing this comparative study Between microscopic and endoscopic tympanoplasty. We will be comparing their outcomes in terms of graft uptake and PTA at 3 months and 6 months interval post operatively. |