Clinical trial NCT03812159: Clinical Feasibility Study of Preoperative Surgical Planning
Official title: Clinical Feasibility Study of Preoperative Surgical Planning for Craniosynostosis Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Craniosynostoses
Keywords: Shape analysis
Computer-assisted surgical plan
Surgical planning
Computational anatomy
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-01-23
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main goal of this procedure is to reduce the risk of elevated intracranial pressure and to provide a more normal cranial shape and volume. Personalized surgical planning systems to optimize intervention and leverage surgical expertise in the reconstruction of the cranial vault do not exist. Thus, the expertise of the surgeon is paramount for the success of the surgical correction of craniosynostosis. The goal of our project is to evaluate the feasibility and utility of a surgical plan derived from software developed at Children's National, iCSPlan.

Detailed description: Presurgical planning will be performed in patients that require an open crania-vault reconstruction for craniosynostosis. The participants will come from the outpatient clinics of neurosurgery and plastic surgery. The treating physician/study team member will explain and give a copy of Institutional review board (IRB) approved study information letter to the participant's legally authorized representative (LAR).

The investigators will acquire a pre-operative CT-scan, per standard of care, to help assess the synostosis severity, within 4 weeks before the procedure. A week before the surgery, a routine preoperative visit will be done where the participant and/or LAR, if agree to participate in the study, will sign the informed consent document(s).

A presurgical plan will be built and will be recorded in a software, iCSPlan. Although this plan will not be integrated in the OR workflow, if needed, it would be visualized on a desktop monitor, which will be available to the surgical team. This tool will not influence any clinical decision making in the study. Instead, it will work as a rely-on tool in the preparation of the surgery, which may or may not be followed by the surgeon.

Demographic information (sex, age), as well as intraoperative information (Anesthesia length, anesthesia medications, length of surgery, blood loss, # of blood units transfused, complications), will be recorded for analysis. These variables are generally recorded during surgery and add no additional operative time.

Following the surgery, the specialists will evaluate the feasibility of the use of the presurgical plan by completing a questionnaire to report their options on (1): Quality of the surgical outcome; (2) the quality of the surgical strategy, and (3) the utility of the surgical planning in the treatment. The questions will be answered on a 5-point Likert scale, ranging from "not useful/strongly dislike" to "very useful/strongly like".

All study team pre-screening materials that contain participants information will be maintained on password protected computers. Only authorized study team members will have access to the pre-screening materials. Any pre-screening protected health information (PHI) that is collected will be destroyed once study enrollment is completed.

Eligibility criteria: Inclusion Criteria:

1. Patients under 18 years of age.
2. Diagnosis of craniosynostosis.
3. Scheduled for open crania vault reconstruction.
4. Patients seen in Children's National Medical Center.

Exclusion Criteria:

1. Lack of interest in participating and refusal to consent.
2. Plan for endoscopic craniectomy of synostosis.

Primary outcomes:
measure: To evaluate the feasibility of a surgical planning software (iCSPlan) for open cranial vault reconstructions assessed by how often will the surgeon use or discard the surgical plan
timeFrame: a week before surgery
Secondary outcomes:
measure: To evaluate the utility of the surgical planning software (iCSPlan) assessed by a 5-point Likert scale questionnaire.
timeFrame: A week before surgery
measure: To evaluate the quality of the surgical strategy and the surgical outcome built by the surgical planning software (iCSPlan) surgeons will complete a 5-point Likert scale questionnaire.
timeFrame: a week before surgery
measure: To evaluate the impact of the surgical planning software (iCSplan) assessed by the difference in the length of surgery if the plan is used.
timeFrame: The day of surgery (One day)
measure: To evaluate the intra-operative impact of using a surgical planning software (iCSPlan) assessed by the amount of blood loss, and thus, the amount of transfusion needed.
timeFrame: The day of surgery (One day)
measure: To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the complications encountered 30-days after the surgery.
timeFrame: 30 days after surgery.
measure: To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the length of stay.
timeFrame: One month.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Childrens National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: Gary Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porras AR, Paniagua B, Ensel S, Keating R, Rogers GF, Enquobahrie A, Linguraru MG. Locally Affine Diffeomorphic Surface Registration and Its Application to Surgical Planning of Fronto-Orbital Advancement. IEEE Trans Med Imaging. 2018 Jul;37(7):1690-1700. doi: 10.1109/TMI.2018.2816402.
citation: Porras AR, Zukic D, Equobahrie A, Rogers GF, Linguraru MG. Personalized Optimal Planning for the Surgical Correction of Metopic Craniosynostosis. Clin Image Based Proced. 2016;2016:60-67. doi: 10.1007/978-3-319-46472-5_8. Epub 2016 Sep 21.
citation: Porras AR, Paniagua B, Enquobahrie A, Ensel S, Shah H, Keating R, Rogers GF, Linguraru MG. Locally affine diffeomorphic surface registration for planning of metopic craniosynostosis surgery. Med Image Comput Comput Assist Interv. 2017 Sep;10434:479-487. doi: 10.1007/978-3-319-66185-8_54. Epub 2017 Sep 4.