Clinical Feasibility Study of Preoperative Surgical Planning
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/30/2019 |
| Start Date: | May 1, 2019 |
| End Date: | February 20, 2021 |
| Contact: | Gary Rogers, MD |
| Email: | grogers@cnmc.org |
| Phone: | 202-476-6767 |
Clinical Feasibility Study of Preoperative Surgical Planning for Craniosynostosis Procedures
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.
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.
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.
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.
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.
We found this trial at
1
site
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Gary F Rogers, MD
Phone: 202-476-4548
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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