Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607746154860 Date of Registration: 06/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outcomes of Endoscopic Type I Cartilage Tympanoplasty With and Without Meatal Flap Elevation
Official scientific title A prospective, two-arm, parallel-group randomized controlled trial of endoscopic type I cartilage tympanoplasty with versus without tympanomeatal flap elevation in adults with inactive tubotympanic chronic suppurative otitis media
Brief summary describing the background and objectives of the trial Chronic suppurative otitis media is a common cause of persistent tympanic membrane perforation and conductive hearing loss, and type I tympanoplasty is the standard surgical repair. Elevation of a tympanomeatal flap is a traditional step that improves exposure but may increase postoperative pain and operative time; with modern endoscopy, a flapless transcanal push-through technique is possible, but its relative outcomes are unclear. This single-centre randomized controlled trial compared endoscopic type I cartilage tympanoplasty with versus without tympanomeatal flap elevation in 50 adults with inactive tubotympanic CSOM. Co-primary outcomes were graft uptake and air–bone gap closure at three months; secondary outcomes were early postoperative pain, audiometric thresholds and complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2024
Actual trial start date 01/12/2024
Anticipated date of last follow up 01/10/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Endoscopic type I cartilage tympanoplasty WITH tympanomeatal flap elevation Single surgical procedure under general anaesthesia Single operative session; follow-up to 3 months A superiorly based tympanomeatal flap was raised through radial incisions (3 and 9 o'clock), the annulus exposed and perforation edges freshened. A tragal cartilage–perichondrium graft (~0.5 mm) was placed by underlay with Gelfoam support, the flap repositioned, and the canal packed with antibiotic-soaked Gelfoam. Single 0° 3 mm rigid endoscope, single surgeon. 25 Active-Treatment of Control Group
Experimental Group Endoscopic type I cartilage tympanoplasty WITHOUT flap elevation Single surgical procedure under general anaesthesia Single operative session; follow-up to 3 months No tympanomeatal flap was raised. After freshening the perforation edges, a tragal cartilage–perichondrium graft (~0.5 mm) was folded and pushed medially through the perforation under endoscopic vision, then unfolded into an underlay position beneath the remnant. Canal packed with antibiotic-soaked Gelfoam. Single 0° 3 mm rigid endoscope, single surgeon. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18 years or older Inactive tubotympanic chronic suppurative otitis media (CSOM) Dry central tympanic membrane perforation for at least 3 months Conductive hearing loss with no sensorineural component (normal bone conduction) Intact, mobile ossicular chain Normal middle-ear mucosa on otoscopic/endoscopic examination Unfit for general anaesthesia Cervical-spine disorders limiting operative positioning Active otorrhoea, granulation tissue or mucosal inflammation Atticoantral disease or cholesteatoma Traumatic perforation Previous (revision) ear surgery on the affected ear Otitis externa Sensorineural hearing loss Refusal to participate Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/12/2024 Faculty of Medicine Research Ethics Committee Minia University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Minia University Minya 61511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Graft uptake/success (complete vs partial vs failed/re-perforated), assessed by endoscopic otoscopy 3 months postoperatively
Primary Outcome Hearing improvement — air–bone gap (ABG) closure to ≤20 dB or a reduction of ≥10 dB from baseline, by pure-tone audiometry 3 months postoperatively
Secondary Outcome Early postoperative pain on the Visual Analogue Scale (VAS, 0–10) 4 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Hospital University Hospital, Faculty of Medicine Minya Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Shaban Mohamed Qotb Faculty of Medicine, Minia University Minya Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia University Faculty of Medicine, Minia University Minya Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Shaban mohamed.shabanmedical@gmail.com +201156308414 Faculty of Medicine, Minia University
City Postal code Country Position/Affiliation
Minya Egypt Resident
Role Name Email Phone Street address
Public Enquiries Mohamed Shaban mohamed.shabanmedical@gmail.com +201156308414 Faculty of Medicine, Minia University
City Postal code Country Position/Affiliation
Minya Egypt Resident
Role Name Email Phone Street address
Scientific Enquiries Mohamed Shaban mohamed.shabanmedical@gmail.com +201156308414 Faculty of Medicine, Minia University
City Postal code Country Position/Affiliation
Minya Egypt Resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The de-identified individual participant datasets generated and analysed during this study are available from the corresponding author on reasonable request. Patient confidentiality precludes public deposition. Study Protocol Available from the time of publication, with no end date, on reasonable request to the corresponding author. Requests should be made in writing to the corresponding author and will be considered for methodologically sound proposals, subject to institutional and ethical approval.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 27/06/2026 Reviewer’s comments This single-centre randomized controlled trial compared endoscopic type I cartilage tympanoplasty performed with tympanomeatal flap elevation versus the flapless transcanal push-through technique in 50 adults with inactive tubotympanic CSOM. Co-primary outcomes were graft uptake and air–bone gap closure at three months; secondary outcomes were early postoperative pain, audiometric thresholds and complications. Chronic suppurative otitis media is a common cause of persistent tympanic membrane perforation and conductive hearing loss, and type I tympanoplasty is the standard surgical repair. Elevation of a tympanomeatal flap is a traditional step that improves exposure but may increase postoperative pain and operative time; with modern endoscopy, a flapless transcanal push-through technique is possible, but its relative outcomes are unclear. This single-centre randomized controlled trial compared endoscopic type I cartilage tympanoplasty with versus without tympanomeatal flap elevation in 50 adults with inactive tubotympanic CSOM. Co-primary outcomes were graft uptake and air–bone gap closure at three months; secondary outcomes were early postoperative pain, audiometric thresholds and complications.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/07/2026 PACTR Admin 01 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/06/2026 Reviewer’s comments personal efforts of the authors, Faculty of Medicine, Minia University, Minya, , Egypt, , Mohamed Shaban Mohamed Qotb, Faculty of Medicine, Minia University, Minya, , Egypt, Self Funded,