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Targeting Surgeons' Decision-Making for Cleft Lip Surgery

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ClinicalTrials.gov Identifier: NCT03537976
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Wake Forest University Health Sciences
Boston Children's Hospital
Massachusetts General Hospital
Tufts Medical Center
University of Bath
Information provided by (Responsible Party):
Tufts University

Brief Summary:
Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures and visual aids of the Intervention with the systematic subjective assessment in order to determine decisions surgery.

Condition or disease Intervention/treatment Phase
Cleft Palate Cleft Lip Other: Static Images and Facial Videos Not Applicable

Detailed Description:

The standard-of-care to evaluate patients for lip revision surgery relies on a subjective assessment by the surgeon of the static face. The important role of function or movement generally has been given far less consideration mainly because of the challenges faced by surgeons (e.g., the amount/quality of the tissue available to alter movement). Presently, even when surgeons do attempt to assess function, they do so in a subjective manner because there are no quantitative/visual aids to incorporate functional assessment into their treatment planning and decisions regarding lip surgery.

The Intervention approach proposed here has been refined sufficiently with surgeon feedback to allow surgeons to broaden their "vista" of the patients' 'movement and form' problems. Potentially, having identified a movement/form problem(s), surgeons could contemplate what needs to be done to improve patient specific problem(s). Importantly, pilot studies demonstrated that the Intervention had a definite impact on surgeons' decisions for lip revision: Surgeons substantially, but variably, changed their problem list and treatment planning goals. Thus, a goal of this study is to collect surgical outcome data which will be used primarily to monitor adverse events but also will provide preliminary information on improvement in patient outcomes (facial form and movement) when surgeons use the Intervention. In addition, given that revision surgery is very common after the primary lip repair, it is important to understand surgeons' decision-making with the use of the Intervention, to determine surgeons' goals and expectations for primary lip repair surgery, and to understand the surgical limitations that may lead to subsequent revision surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Surgeons' Decision-Making for Cleft Lip Surgery
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Static Images and Facial Videos
2D and 3D still and video images obtained from each patient before surgery.
Other: Static Images and Facial Videos
2D and 3D still and video images obtained from each patient before surgery.




Primary Outcome Measures :
  1. Surgeon-raters' decision making in lip revision [ Time Frame: Through study completion, an average of 2 years ]
    Outcomes are based on transcribing the In-Depth-Interviews (IDIs) that will be conducted with the surgeon-raters; coding the transcript with an a priori structure in mind (using the interview format as a starting point) but then using Grounded Theory to guide further coding in order to capitalize on themes that emerge that may not conform to the interview format. Themes will be developed (from the interview format and/or the emergent themes) that we will group by frequency as well as to their relevance to hypothesis generation as to how surgeon-raters might learn about and integrate patient data over time.

  2. Surgeon-raters' decision making in primary lip repair [ Time Frame: Through study completion, an average of 2 years ]

    Outcomes are based on transcribing the IDIs that will be conducted with the surgeon-raters; coding the transcript with an a priori structure in mind (using the interview format as a starting point) but then using Grounded Theory to guide further coding in order to capitalize on themes that emerge that may not conform to the structured interview format. Themes will be developed (from the interview format and/or the emergent themes) that we will group by frequency as well as to their relevance to hypothesis generation as to how surgeon-raters might learn about and integrate patient data over time.

    This thematic and frequency analysis will be conducted after the SAFS Intervention is conducted with the surgeons for those patients who are in need of lip revision surgery to address objective 1, as well as after the SAFS Intervention is conducted with the surgeons for those patients in need of primary lip repair surgery to address objective 2.



Secondary Outcome Measures :
  1. The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision. [ Time Frame: Through study completion, an average of 2 years ]
    Nominal outcome of the effect of the SAFS on surgeon-raters' treatment plans/goals in terms of whether the surgeon-rater changes his problem list and goals for lip revision.

  2. The quantitative assessment of the extent to which the SAFS changes surgeons' problem list and treatment planning goals for primary lip repair. [ Time Frame: Through study completion, an average of 2 years ]
    Nominal outcome of the effect of the SAFS on surgeon-raters' treatment plans/goals in terms of whether and how much the surgeon-rater changes his problem list and goals for primary lip repair.

  3. The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision as a function of surgical expertise. [ Time Frame: Through study completion, an average of 2 years ]
    Nominal outcome of the effect of the SAFS on surgeon-raters' treatment plans/goals in terms of whether the surgeon-rater changes his problem list and goals for lip revision based on the length of surgical experience (in years) of treating patients with cleft lip and palate.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Lip Revision):

  • Age 4 to 21 years
  • Presence of a previously repaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate
  • The professional clinical recommendation by the craniofacial plastic surgeon for a full or partial thickness lip revision

Exclusion Criteria (Lip Revision):

  • Lip revision surgery within the past two years
  • A diagnosis of a craniofacial anomaly other than cleft lip (and palate)
  • A medical history of collagen vascular disease, or systemic neurologic impairment
  • Mental, visual, or hearing impairment to the extent that comprehension or ability to perform tests associated with the collection of the imaging data is hampered

Inclusion Criteria (Lip Repair)

  • Age birth to 8 months
  • Presence of an unrepaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate

Exclusion Criteria (Lip Repair)

  • A diagnosis of a craniofacial anomaly other than cleft lip (and palate)
  • A medical diagnosis of collagen vascular disease, and systemic neurologic impairment
  • Mental, visual, or hearing impairment to the extent that the infant's ability to perform tests associated with the collection of the imaging data is hampered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537976


Contacts
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Contact: Carroll Ann Trotman 617-636-0846 Carroll_Ann.Trotman@tufts.edu

Locations
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United States, Massachusetts
Tufts University School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Carroll Ann Trotman       Carroll_Ann.Trotman@tufts.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Facial Animation Lab    919-537-3207      
Sponsors and Collaborators
Tufts University
University of North Carolina, Chapel Hill
Wake Forest University Health Sciences
Boston Children's Hospital
Massachusetts General Hospital
Tufts Medical Center
University of Bath
Investigators
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Principal Investigator: Carroll Ann Trotman Tufts University School of Dental Medicine
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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03537976    
Other Study ID Numbers: 12250
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities