Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070811
Status:
COMPLETED
Last Update Posted:
2013-07-04
First Post:
2003-10-08
Brief Title:
Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Functional Outcomes of Cleft Lip and Lip Revision Surgery
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 judgmentsratings 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 clinicians 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 institutions 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
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 judgmentsratings 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 clinicians 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 institutions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE013814 | NIH | None | httpsreporternihgovquickSearchR01DE013814 |