Eustachian Tube Function and Myringoplasty/Tympanoplasty

NCT01766856 | Terminated

• 1 other identifier: PRO12040564
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether the likely success of closing a hole in the eardrum can be predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that connects the back of the nose with the middle ear. When a person goes up in an airplane and their ears "pop" or when one yawns and their ears "pop", that is the Eustachian tube opening. The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as in the environment and keeping the middle ear free of fluid. It is thought that in children with middle-ear disease, the muscles that open the Eustachian tube do not work very well; this seems to get better in many children as they get older. It is thought that poor Eustachian tube function is the cause of failures when holes in the eardrum are patched and also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see whether it can be predicted, based on testing Eustachian tube function before surgery, whether patching the eardrum will be successful and whether fluid will come back in the ear after it is patched.

Conditions

Tympanic Membrane Perforation

Keywords

perforation; tympanoplasty; myringoplasty; Eustachian tube function; tympanostomy tube

Outcome Measures

Primary Outcomes (2)

• Healing of perforation

  Evidence of intact eardrum at 12 months after surgery

  12 months

• Recurrence of otitis media

  Recurrence of otitis media (acute otitis media and/or otitis media with effusion) by 12 months

  by 12 months

Study Arms (1)

children undergoing myringoplasty/tympanoplasty

child having repair of eardrum because of hole in eardrum after tube extruded or after tube removal

Other: Eustachian tube function testing

Interventions

Eustachian tube function testing OTHER

Eustachian tube function testing will consist of some or all of the following tests: Inflation/Deflation test, Forced Response test, Compliance test,Valsalva, Toynbee and Sniffing

children undergoing myringoplasty/tympanoplasty

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing myringoplasty/tympanoplasty for eardrum perforation after a tube or after a retained tube is removed.

You may qualify if:

• years old
• being scheduled for myringoplasty/tympanoplasty with removal of a patent tube or for repair of existing eardrum perforation remaining after a tube
• less than or equal to 8 weeks prior to surgery

You may not qualify if:

• syndromic or with craniofacial malformation (eg, Down syndrome, cleft palate)
• parent anticipates being unable to keep appointments (e.g., moving out of area)
• child unable to tolerate testing

Sponsors & Collaborators

• University of Pittsburgh: lead
• Department of Pediatric Otolaryngology: collaborator

Study Sites (1)

ENT Research Center, Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Officials

• Margaretha L Casselbrant, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 11, 2013
• Study Start: November 1, 2012
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)