Furlow Palatoplasty With Tensor Tenopexy

Study Overview
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Brief Summary
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This study compares a standard method for palate repair (the Furlow palatoplasty) with a modification of that method to determine which, if either, is more effective in reducing the duration of middle-ear disease (fluid in the ear) in cleft palate patients.

Detailed Description
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Almost all infants and young children who were born with a cleft palate (with or without a cleft lip) have middle-ear disease and this condition can last into late childhood and early adolescence. The type of middle-ear disease that usually occurs in cleft palate patients is not associated with pain or symptoms, but the fluid in the middle-ear causes poor hearing and sometimes problems with balance. Past studies show that the middle-ear disease in infants and children with cleft palate is caused by their inability to open a natural tube that connects the back of the nose with the middle-ear (called the Eustachian tube). Opening the Eustachian tube is required to keep the pressure in the middle-ear equal to that of the atmosphere which prevents fluid from building up in the middle-ear. For this reason, middle-ear disease is usually treated by placing a small plastic tube in the eardrum which keeps the middle-ear pressure and pressure in the room (atmospheric pressure) equal even when the Eustachian tube fails to open. However, the disease often returns when the plastic tube becomes blocked or falls out and a new tube needs to be placed in the eardrum. The actions of two small muscles, the levator veli palatini (LVP) muscle and the tensor veli palatini (TVP) muscle combine to open the Eustachian tube and the LVP muscle plays a role in raising the palate during speech, swallowing and other activities. Both muscles run through the soft palate. In children with cleft palate, the usual position, orientation and function of both of these muscles are abnormal and few surgical procedures for palate repair focus on re-establishing a more normal orientation and attachment of these muscles. One well accepted method for repair of the palate, the Furlow palatoplasty is the standard procedure used by the two cleft palate surgeons involved in this study. During the Furlow palatoplasty the attachment of the TVP muscle is cut. Recently, a modification of the Furlow palatoplasty, called a tensor tenopexy, has been described that involves attaching the cut part of the TVP muscle to a bony hook in the soft palate in an effort to improve Eustachian tube function and lead to less middle-ear disease. One small study presented results suggesting that middle-ear disease was cured at an earlier age in those cleft palate patients who had their palates repaired using the modified Furlow procedure when compared to a number of other methods of palate repair, but these comparisons did not include the standard Furlow procedure. However, the design of that study was poor and the possible benefits of this small modification in the surgical procedure with respect to middle-ear disease need to be evaluated in a more formal study. Because the surgical procedures for the Furlow palatoplasty and the modified Furlow procedure are identical with the exception of the addition of anchoring the cut muscle attachment, a study of these two procedures will allow us to determine if the modified procedure does or does not improve middle-ear disease at an earlier age in patients with cleft palate.

Official Title
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Furlow Palatoplasty With Tensor Tenopexy for Otitis Media

Conditions
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Otitis Media, Cleft Palate

Intervention / Treatment
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* Procedure: palatoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cleft palate with or without cleft lip classified as Veau I through IV parental consent for procedure patients assigned to Drs. Losee, Davit, Grundwaldt, or Goldstein for palatoplasty children up to 15 months of age who have not had palatoplasty but have tympanostomy tubes Exclusion Criteria: patients with syndromic clefts or genetic abnormalities

Ages Eligible for Study
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Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Furlow palatoplasty<br>standard procedure | Procedure: palatoplasty<br>* procedure to close cleft palate<br>|
| Experimental: modified Furlow palatoplasty<br>standard procedure plus modification | Procedure: palatoplasty<br>* procedure to close cleft palate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hearing status | results of audiometric testing | 3-year visit | 
| otitis media status | diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit | 3 years of age | 
| Eustachian tube function (ETF) measures | ETF test results | 3-year visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Weighted Speech Score | obtained as standard of care | 3 years of age | 
| nasalence ratio | obtained as standard of care | 3 years of age | 
| McKay-Kummer SMAP test | obtained as standard of care | 3 years of age | 
| duration of speech therapy |  | by age 7 years | 
| need for revision palatoplasties |  | by 7 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otitis media, cleft palate