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Targeting Surgeons' Decision-Making for Cleft Lip Surgery

Primary Purpose

Cleft Palate, Cleft Lip

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Static Images and Facial Videos
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate

Eligibility Criteria

0 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts University School of Dental MedicineRecruiting
  • University of North CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Static Images and Facial Videos

Arm Description

2D and 3D still and video images obtained from each patient before surgery.

Outcomes

Primary Outcome Measures

Surgeon-raters' decision making in lip revision
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.
Surgeon-raters' decision making in primary lip repair
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

The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision.
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.
The quantitative assessment of the extent to which the SAFS changes surgeons' problem list and treatment planning goals for primary lip repair.
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.
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.
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.

Full Information

First Posted
February 15, 2018
Last Updated
May 21, 2021
Sponsor
Tufts University
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
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1. Study Identification

Unique Protocol Identification Number
NCT03537976
Brief Title
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
Official Title
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate, Cleft Lip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Static Images and Facial Videos
Arm Type
Other
Arm Description
2D and 3D still and video images obtained from each patient before surgery.
Intervention Type
Other
Intervention Name(s)
Static Images and Facial Videos
Intervention Description
2D and 3D still and video images obtained from each patient before surgery.
Primary Outcome Measure Information:
Title
Surgeon-raters' decision making in lip revision
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
Surgeon-raters' decision making in primary lip repair
Description
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.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision.
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
The quantitative assessment of the extent to which the SAFS changes surgeons' problem list and treatment planning goals for primary lip repair.
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
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.
Description
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.
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carroll Ann Trotman
Phone
617-636-0846
Email
Carroll_Ann.Trotman@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carroll Ann Trotman
Organizational Affiliation
Tufts University School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carroll Ann Trotman
Email
Carroll_Ann.Trotman@tufts.edu
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Facial Animation Lab
Phone
919-537-3207

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Targeting Surgeons' Decision-Making for Cleft Lip Surgery

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