Clinical trial NCT00070811: Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
Official title: Functional Outcomes of Cleft Lip and Lip Revision Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip
Cleft Lip and Palate
Keywords: Facial form
Facial animation
Lip muscle reconstruction
Lip form
Lip function
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2003-10-13
Enrollment: 127
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited and screened mainly in the UNC Craniofacial Center, the Graduate Orthodontic Clinic, the Pediatric Dentistry Clinic, and the Orthodontic Faculty Practice of the University of North Carolina.

Brief summary: The purpose of this study is to determine whether secondary (revision) surgery to the lip in patients with cleft lip and palate is effective in improving lip function and appearance.

Detailed description: Children born with clefting of the upper lip exhibit obvious disfigurement of the upper lip and nose. As illustrated below, primary lip surgery of the infant dramatically improves the severe deformity of the perioral and nasal region. It is widely recognized, however, that most patients require additional lip surgeries for an optimum esthetic result. Clinicians often disagree as to when this end point is reached since the decision for additional lip revision is based on subjective clinical assessments.

Facial morphology during function has a major impact on how a person is perceived in society and is known to be an important component of the esthetic outcome for cleft patients, but it has been particularly difficult to incorporate measures of lip function into the decision-making process. It is likely that the different surgical procedures for both primary lip closure and secondary lip revision could be improved if the effects of alternative surgical techniques on function were better understood. The subjects for this project consist of two cleft lip and palate patient groups treated at the University of North Carolina (UNC) Craniofacial Center: one cleft group will be patients who are candidates for additional lip revision surgery; the other cleft group will be patients who have been judged not to need lip revision; and a matched non-cleft group who present for routine dental care at UNC School of Dentistry. The goals of this project are to objectively measure and quantify functional facial impairment in cleft patients, and to establish more reliable, functionally relevant outcome criteria for treatment planning and evaluation of these individuals. Our specific aims, therefore, are to

1. In a prospective non-randomized controlled clinical trial, evaluate the efficacy of lip revision surgery by a) Examining longitudinal changes in function after lip revision, and b) Examining whether the change in function after lip revision differs from the change that would be observed due to maturation only in the matched non-cleft 'normal' group, and the change in the cleft but non-lip revised group.
2. a) Estimate the effect of cleft lip and palate on function after primary lip and palate repair but prior to lip revision surgery by comparing those patients scheduled to receive a lip revision with those who are judged not to need a lip revision, and b) Estimate the impairment in function in cleft lip and palate patients without lip revision relative to matched non-cleft subjects.
3. Compare the assessments of dynamic lip function provided by objective measures with subjective clinical judgments/ratings of craniofacial plastic surgeons who perform lip revision surgery, and evaluate the potential of the new methods for clinical application.
4. Evaluate whether objective information when added to the clinician's subjective evaluation of a patient alters the surgical treatment plan or the goals of treatment when subjective and objective information are incorporated in the decision-making and treatment planning process. This specific aim will be useful in adapting and assessing the potential of the new objective methods for application in a clinical setting.
5. To establish 'parameters of care' criteria for secondary lip revision treatment decision-making based on standardized, systematic subjective evaluation, and an objective measurement of movement capacity during function of the upper lip.
6. Assess the long-term effects of maturation on function following lip revision by continuing data-collection beyond the one-year post-revision on patients recruited during the period of the initial grant and long-term follow-up (18 and 30 months) on newly recruited lip revision patients, and in so doing, evaluate the efficacy of cleft lip revision surgery.

To address these aims, we have identified a group of highly qualified individuals with widely recognized expertise in the application of the proposed methodologies, and a panel of surgeons experienced in cleft care for clinical evaluation of outcomes. This expertise, the availability of an appropriate patient resource, and the home institution's 40-year history of strong commitment to the care of these patients and craniofacial research, all favor success in meeting the goals of the project.

Eligibility criteria: 1. Children:

   Cleft lip and palate revision and non-revision patients.

   Inclusion criteria:
   * A previously-repaired complete unilateral or bilateral cleft lip and cleft palate;
   * For the lip revision patients, the professional clinical recommendation by the Center's craniofacial plastic surgeon for a full-thickness lip revision;
   * Patient interest / parent willingness to participate in the study;
   * An ability to comprehend verbal instructions; and
   * An age range of 5-17 yrs.

   Exclusion criteria:
   * The presence of an isolated cleft lip;
   * Previous lip-revision surgery or other facial soft-tissue surgery;
   * Previous orthognathic surgery;
   * A diagnosis of a craniofacial anomaly other than cleft lip and palate;
   * A medical history of diabetes, collagen vascular disease, systemic neurologic impairment; or
   * Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered.

   Non-cleft subjects.

   Inclusion criteria:
   * Patient interest / parent willingness to participate in the study;
   * An ability to comprehend verbal instructions; and
   * An age range of 5-17 yrs.

   Exclusion criteria:
   * Previous orthognathic or facial soft-tissue surgery;
   * A medical history of diabetes, collagen vascular disease, systemic neurologic impairment; or
   * Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered.
2. Infants

Cleft lip and palate patients.

Inclusion Criteria:

* The professional clinical recommendation by the Center's craniofacial plastic surgeon for a cleft lip repair surgery;
* Parent willingness to have baby participate in the study;
* An age range of 0-6 months.

Exclusion Criteria:

* Has had surgery for any reason
* A diagnosis of a craniofacial anomaly other than cleft lip and palate;
* A medical history of diabetes, collagen vascular disease, and systemic neurologic impairment

Non-cleft subjects.

Inclusion Criteria:

* Parent willingness to have baby participate in the study;
* An age range of 0-6 months.

Exclusion Criteria

* Has had surgery for any reason including bone surgery
* A medical history of diabetes, collagen vascular disease, and systemic neurological impairment

Primary outcomes:
measure: Facial movement/animation
timeFrame: 6
Secondary outcomes:
measure: Lip Force
timeFrame: 6
measure: EMG
timeFrame: 6
measure: Lip sensation
timeFrame: 6
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of NC at Chapel Hill
name: Carroll-Ann Trotman, BDS, MA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreatta RD, Barlow SM. Somatosensory gating is dependent on the rate of force recruitment in the human orofacial system. J Speech Lang Hear Res. 2009 Dec;52(6):1566-78. doi: 10.1044/1092-4388(2009/08-0116). Epub 2009 Aug 28.
citation: Trotman CA, Faraway JJ, Essick GK. Three-dimensional nasolabial displacement during movement in repaired cleft lip and palate patients. Plast Reconstr Surg. 2000 Apr;105(4):1273-83. doi: 10.1097/00006534-200004040-00003.
citation: Trotman CA, Faraway JJ, Silvester KT, Greenlee GM, Johnston LE Jr. Sensitivity of a method for the analysis of facial mobility. I. Vector of displacement. Cleft Palate Craniofac J. 1998 Mar;35(2):132-41. doi: 10.1597/1545-1569_1998_035_0132_soamft_2.3.co_2.
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citation: Trotman CA, Phillips C, Essick GK, Faraway JJ, Barlow SM, Losken HW, van Aalst J, Rogers L. Functional outcomes of cleft lip surgery. Part I: Study design and surgeon ratings of lip disability and need for lip revision. Cleft Palate Craniofac J. 2007 Nov;44(6):598-606. doi: 10.1597/06-124.1.
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citation: Ritter K, Trotman CA, Phillips C. Validity of subjective evaluations for the assessment of lip scarring and impairment. Cleft Palate Craniofac J. 2002 Nov;39(6):587-96. doi: 10.1597/1545-1569_2002_039_0587_voseft_2.0.co_2.
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