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Clinical Feasibility Study of Preoperative Surgical Planning

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ClinicalTrials.gov Identifier: NCT03812159
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Gary F. Rogers, MD, Children's Research Institute

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.

Condition or disease Intervention/treatment Phase
Craniosynostoses Device: iCSPlan Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Feasibility Study of Preoperative Surgical Planning for Craniosynostosis Procedures
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : August 20, 2021


Arm Intervention/treatment
Experimental: Presurgical planning
Undergo crania-vault reconstruction following the presurgical planning (iCSPlan)
Device: iCSPlan

The Investigator will acquire a routine pre-operative CT-scan to help assess the synostosis severity. A week before the surgery a routine preoperative visit will be done. If the potential subject agrees to participate in the study, a presurgical plan will be built, and based on the CT scan, it will (1) quantify shape differences between pathological and healthy cranial shapes; (2) compensates for brain and cranial growth during the months between diagnosis, treatment and recovery; and (3) guides bone-cuts and bone-placement for the simplest and optimal surgical procedure.

Finally this plan will be recorded in a software, iCSPlan, which will be reviewed by the surgeon. If it is accepted, it will be available during the surgery as a rely-on tool which may or may not be followed.





Primary Outcome Measures :
  1. 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 [ Time Frame: a week before surgery ]
    Preoperative planning for cranial vault reconstruction will be built in patients under 18 years old with craniosynostosis. We will document the number of times the surgical plan is followed by the surgeon.


Secondary Outcome Measures :
  1. To evaluate the utility of the surgical planning software (iCSPlan) assessed by a 5-point Likert scale questionnaire. [ Time Frame: A week before surgery ]

    Surgeons will review the iCSPlan. To evaluate the utility of the plan, they will complete a questionnaire ranging from 1-5:

    1. Not at all useful;
    2. Slightly useful;
    3. Moderately useful;
    4. Very useful;
    5. Extremely useful.

  2. 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. [ Time Frame: a week before surgery ]

    After reviewing the iCSPlan, surgeons will evaluate the quality of the surgical strategy and outcome by completing a questionnaire ranging from 1-5.

    1: Very poor 2. Poor 3. Fair 4. Good 5. Excellent


  3. To evaluate the impact of the surgical planning software (iCSplan) assessed by the difference in the length of surgery if the plan is used. [ Time Frame: The day of surgery (One day) ]
    Intra-operative variables such as time of surgery is a quantitative measure that would represent the effect of the use of the iCSPlan. We will compare this value in patients for whom the surgical plan was used and was not used.

  4. 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. [ Time Frame: The day of surgery (One day) ]
    One of the major concern during an open cranial vault reconstruction is the amount of blood loss. Measuring this variable and the number of blood units transfused will let us evaluate the impact of the iCSPlan.

  5. 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. [ Time Frame: 30 days after surgery. ]
    Complications such as infection, bleeding, reintervention, brain injury, cranial bone loss, among others, will be recorded in a period of 30 days after the surgery. We will compare the number of complications encountered in patients for whom the surgical plan was used and was not used.

  6. To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the length of stay. [ Time Frame: One month. ]
    We will compare the length of stay in patients for whom the surgical plan was used and was not used.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812159


Contacts
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Contact: Gary Rogers, MD 202-476-6767 grogers@cnmc.org
Contact: Esperanza Mantilla Rivas, MD 202-476-4548 emantillar@childrensnational.org

Locations
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United States, District of Columbia
Childrens National Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Gary F Rogers, MD    202-476-4548    grogers@childrensnational.org   
Contact: Esperanza Mantilla Rivas, MD    2024764548    emantillar@childrensnational.org   
Principal Investigator: Gary F Rogers, MD         
Sub-Investigator: Esperanza Mantilla Rivas, MD         
Sponsors and Collaborators
Gary F. Rogers, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Gary Rogers, MD Children's National Health System

Publications:
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Responsible Party: Gary F. Rogers, MD, Principal Investigator, Children's Research Institute
ClinicalTrials.gov Identifier: NCT03812159     History of Changes
Other Study ID Numbers: Pro00011015
R42HD081712 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Gary F. Rogers, MD, Children's Research Institute:
Shape analysis
Computer-assited surgical plan
Surgical planning
Computational anatomy

Additional relevant MeSH terms:
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Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities