Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01535131 |
| Other study ID # |
PRO11060248 |
| Secondary ID |
R01DC011524 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 28, 2012 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
July 2022 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
