Partial Thickness vs Full Thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty

NCT07471191 | Not Yet Recruiting DMC

• 1 other identifier: grafts in endoscopy
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Objective: Compare 6-month graft success rates between 0.5 mm sliced and 1.8 mm full-thickness tragal cartilage grafts.(3) H1: Sliced cartilage yields ≥90% success versus ≤80% for full-thickness.(3) H0: No difference between arms. Secondary Objectives:

• PTA-ABG closure at 6/12 months.(4)
• Speech discrimination score improvement.(4)
• Operative time.(6)

Conditions

Tympanoplasty Surgery

Outcome Measures

Primary Outcomes (1)

• Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.

  Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.

  baseline

Interventions

endoscope DEVICE

endoscopic type 1 tympano plasty

Also known as: tympanoplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion (all required): * Age 18-65 years. * safe chronic perforation ≥6 months. * Subtotal (25-75%) or large (\>75%) pars tensa defect. * Dry ear ≥3 months (culture-negative). * Intact ossicles, healthy mucosa. * Viable tragal cartilage. * Informed written consent capability. Exclusion criteria : * unsafe otitis, * active discharge, * Eustachian dysfunction e.g cleft palate, * ossicular defects * prior surgery, * unfit patients * non-compliance

You may qualify if:

• Age 18-65 years.
• safe chronic perforation ≥6 months.
• Subtotal (25-75%) or large (\>75%) pars tensa defect.
• Dry ear ≥3 months (culture-negative).
• Intact ossicles, healthy mucosa.
• Viable tragal cartilage.
• Informed written consent capability.

You may not qualify if:

• unsafe otitis,
• active discharge,
• Eustachian dysfunction e.g cleft palate,
• ossicular defects
• prior surgery,
• unfit patients
• non-compliance

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Rizer FM. Overlay versus underlay tympanoplasty. Part II: the study. Laryngoscope. 1997 Dec;107(12 Pt 2):26-36. doi: 10.1097/00005537-199712001-00002.

  PMID: 9395344 BACKGROUND

MeSH Terms

Interventions

Endoscopes; Tympanoplasty

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Monica Gamil Tawfiq

CONTACT

01270882995; gamilmonica25@gmail.com

Ezzat Mohamed Saleh, Prof

CONTACT

01006722404; ezzatsaleh@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03