Targeting Surgeons' Decision-Making for Cleft Lip Surgery
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.
Conditions:
🦠 Cleft Palate 🦠 Cleft Lip
🗓️ Study Start (Actual) 31 January 2018
🗓️ Primary Completion (Estimated) 31 August 2025
✅ Study Completion (Estimated) 31 August 2025
👥 Enrollment (Estimated) 48
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States
📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 0 Months to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 February 2018
  • First Submitted that Met QC Criteria 15 May 2018
  • First Posted 25 May 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 December 2023
  • Last Update Posted 19 December 2023
  • Last Verified December 2023