Quantitative and functional echographic assessment of reconstructed schisis (cleft lip)

When children with a cleft lip are born a recontruction has to be performed in
which the continuity of the m.orbicularis oris has to be restored. After the
surgical intervention the amount of scar tissue and its position have
functional and esthetic consequences. Although the esthetic outcome of an
intervention might clinically assessed, it remains unclear to what extend the
continuity and the functionality of the muscle have been established. For this
reason, it is important to investigate the anatomy of the reconstructed lip.
Moreover, it is unknown to what extend scartissue has an effect on muscle
function. By making detailed anatomical information available, it might be
possible to better evaluate the outcome of treatment. It is also of importance
to quantify the contractive performance of the involved muscle in order to give
the surgeon feed-back To achieve a refinement of the reconstructed method and
to support decision making of further therapy. Two techniques have been
developed to determine the anatomical and functional characteristics of the m.
orbicularis oris by means of ultrasonography ( or echography). Characteristics
of the ultrasound images are being quantified to determine the composition of
tissues. A technique called elastography has been developed to quantify and
visualize the deformation of tissues during function. We hypothesize that scar
tissue can be differentiated from healthy tissue by relative echo level and
that scar tissue shows no active deformation during functional movement while
normal tissue shows up to 25% of deformation with SD of 5-10%.

Objective 1: To determine the differences in composition of tissues and
function of the upper lip between reconstructed cleft lip patients and healthy
subjects.

Objective 2: To test the possibility to detect anatomical and functional
differences prior to and after final reconstructive lip surgery in cleft
patients.

First part of the study:
Case-control study
Duration and setting: The subjects will be asked to make one appointment of 30
minutes for collection of ultrasound data at the out-patients clinic of the
department of Pediatrics Radboud University Nijmegen Medical Centre and to make
3D facial photographs at the out-patients clinic of the department of
Maxillofacial Surgery Radboud University Nijmegen Medical Centre.

Second part of the study:
Cohort study
Duration and setting:
-One appointment of 30 minutes is made with patients one week prior to the
final reconstructive lip surgery to collect ultrasound data and to make facial
photographs.
-Four appointments of 30 minutes are made with subjects ten days, one month, 3
months and six months after surgery to collect ultrasound data and to make 3D
facial photographs
All appointments are held at the out-patients clinic of the department of
Pediatrics Radboud University Nijmegen Medical Centre.

No burden except time. No risks