Clinical Feasibility Study of Preoperative Surgical Planning
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03812159|
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Craniosynostoses||Device: iCSPlan||Not Applicable|
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.
|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|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||November 20, 2021|
|Estimated Study Completion Date :||November 20, 2021|
Experimental: Presurgical planning
Undergo crania-vault reconstruction following the presurgical planning (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.
- 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.
- 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:
- Not at all useful;
- Slightly useful;
- Moderately useful;
- Very useful;
- Extremely useful.
- 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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Gary Rogers, MDemail@example.com|
|Contact: Esperanza Mantilla Rivas, MDfirstname.lastname@example.org|
|United States, District of Columbia|
|Childrens National Hospital||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Gary F Rogers, MD 202-476-4548 email@example.com|
|Contact: Esperanza Mantilla Rivas, MD 2024764548 firstname.lastname@example.org|
|Principal Investigator: Gary F Rogers, MD|
|Sub-Investigator: Esperanza Mantilla Rivas, MD|
|Principal Investigator:||Gary Rogers, MD||Children's National Health System|