Visual Aids for Cleft Lip Surgery

Recruiting at 1 trial location

Overseen By Carroll Ann Trotman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Craniofacial anomaly, Collagen vascular, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Static Images and Facial Videos for cleft lip surgery?

The research on surgical simulators for cleft lip planning and repair shows that using visual aids like 3D simulations helps surgeons practice and improve their skills without risk to patients. This suggests that visual aids, such as static images and facial videos, could be effective in enhancing surgical outcomes by providing a similar educational benefit. ^{1 2 3 4 5}

Is the use of visual aids for cleft lip surgery safe for humans?

Cleft lip repair is generally safe, especially in outpatient settings, but patients with certain health issues, like heart problems, may face more risks. The safety of using visual aids like static images and facial videos hasn't been specifically studied, but cleft lip surgeries themselves have a good safety record. ^{6 7 8 9 10}

How does the treatment 'Visual Aids for Cleft Lip Surgery' differ from other treatments for cleft lip?

The 'Visual Aids for Cleft Lip Surgery' treatment is unique because it uses advanced visual tools like 3D printed models and digital simulators to help surgeons plan and practice cleft lip repairs. This approach allows for better preoperative planning and hands-on practice without risk to patients, which is not typically available with traditional cleft lip surgery techniques. ^{2 4 11 12 13}

What is the purpose of this trial?

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.

Research Team

Carroll Ann Trotman

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

This trial is for individuals aged 4 to 21 with a previously repaired unilateral or bilateral cleft lip and palate, including a complete cleft of the primary palate and at least a partial cleft of the secondary palate. Candidates must be recommended for lip revision surgery by their craniofacial plastic surgeon.

Inclusion Criteria

I am between 4 and 21 years old.

I had surgery to repair a cleft lip and palate.

My surgeon recommends a lip revision surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Surgeons use the SAFS Intervention to assess and plan treatment for lip revision and primary lip repair surgeries

2 years

Follow-up

Participants are monitored for surgical outcomes and adverse events

2 years

Treatment Details

Interventions

• Static Images and Facial Videos

Trial Overview The study aims to understand how surgeons use visual aids like static images and facial videos alongside objective measures in decision-making for cleft lip surgery. It involves comparing different approaches using patient cohorts undergoing lip repair or revision surgeries.

Participant Groups

Group I: Static Images and Facial Videos Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

University of Bath

Collaborator

Trials

104

Recruited

16,400+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Findings from Research

A risk map was developed in the Oral and Maxillofacial Surgery Service at the University Hospital 'Virgen de las Nieves' to identify and minimize adverse effects (AEs), with 33 AEs identified during the study period from June 2017 to May 2018.

The study found that the Surgical Area had a higher incidence of AEs (22) compared to Outpatient Clinic and Hospital Discharge areas (6), highlighting the need for targeted safety measures in surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a risk map in an oral and maxillofacial surgical unit]. Sánchez López, JD., Cambil Martín, J., Villegas Calvo, M., et al.[2020]

Out of 409,991 patients who underwent soft tissue reconstructive procedures from 2005 to 2010, 4.06% experienced adverse events (AEs), indicating that while AEs are not uncommon, the overall rates are lower compared to other surgical disciplines.

Certain patient characteristics, such as older age, male gender, nonwhite ethnicity, and reliance on public insurance, were associated with higher rates of AEs, highlighting the need for targeted quality improvement efforts in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. Hernandez-Boussard, T., McDonald, KM., Rhoads, KF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Decision Considerations and Strategies for Lip Surgery in Patients with Cleft lip/Palate: A Qualitative Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A New Paradigm in Cleft Lip Procedural Excellence: Creation and Preliminary Digital Validation of a Lifelike Simulator. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A National Assessment of Racial and Ethnic Disparities in Cleft Lip Repair. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A surgical simulator for cleft lip planning and repair. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Racial and Ethnic Disparities in Primary Cleft Lip and Cleft Palate Repair. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

[Development of a risk map in an oral and maxillofacial surgical unit]. [2020]

7. Sweden pubmed.ncbi.nlm.nih.gov

In search of a single standardised system for reporting complications in craniofacial surgery: a comparison of three different classifications. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cleft Lip Repair in Premature Infants With Cardiac Risk Factors. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

To Admit or Not to Admit: That is the Cleft Lip Question. Confirming the Safety of Outpatient Cleft Lip Repair. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Assessing the Fisher, Mohler, and Millard Techniques of Cleft Lip Repair Surgery With Eye-Tracking Technology. [2022]

12. Denmark pubmed.ncbi.nlm.nih.gov

Three-dimensional printed haptic model from a prenatal surface-rendered oropalatal sonographic view: a new tool in the surgical planning of cleft lip/palate. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Systematic contact-free 3D topometry of the soft tissue profile in cleft lips. [2008]