Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal Platform (SRP) for Cerebral Aneurysm Clipping Surgery
Objectives: The objective of this clinical study is to determine if the use of the SRP will lead to improved effort and time efficiency in cerebral aneurysm surgery. For this preliminary study, the investigators will assess key time and effort variables associated with prospectively assessed SRP neurosurgery cases in comparison with cases with no SRP rehearsal. This is a single site study with one enrolling site. This study will include a total of 40 cases 20 SRP cases and 20 control cases). SRP and control cases will be randomly selected according to a predetermined alternating sequence.
Cerebral Aneurysm Unruptured
Cerebral Aneurysm Ruptured
Other: Active SRP cases
Other: Control cases
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
|Official Title:||Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal|
- Aneurysm clip time [ Time Frame: At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position ] [ Designated as safety issue: No ]
Number of Clipping attempts:
- Applying a clip (i.e., closing a clip on the aneurysm)
- Removing a clip (i.e., a clip was applied on the aneurysm and then removed)
- Adjusting a clip (i.e., the clip was applied on the aneurysm and then opened, adjusted, and closed again).
- Number of trial aneurysm clips used but not implanted [ Time Frame: At time of surgery-Time from first clip to contact aneurysm to final clip placement ] [ Designated as safety issue: No ]
Number of Clips evaluated:
Defined as clips that were brought in proximity to the aneurysm for evaluation (i.e., were visible in the microscopic field) but were not applied, as observed in the operating microscope's video.
- Temporary clip time [ Time Frame: At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal ] [ Designated as safety issue: No ]
Total Number of minutes of temporary clip occlusion:
Defined as the time the temporary clip is released from the clip applier until the temporary clip is removed. (For several temporary occlusions, a cumulative total of all temporary occlusions and total time of overall temporary occlusion time as observed in the operating microscope's video.)
- Microsurgical time [ Time Frame: At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement ] [ Designated as safety issue: No ]
Number of minutes of total microsurgical time:
Defined as the time elapsed from the time the aneurysm was first observed in the OR microscope until the time that the final clip was applied
- Wasted number of aneurysm clips [ Time Frame: At time of surgery-Time from first aneurysm clip attempt to final clip placement ] [ Designated as safety issue: No ]Number of of aneurysm clips wasted according to OR records.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Active SRP cases
SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.
Other: Active SRP cases
The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.
Placebo Comparator: Control cases
Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.
Other: Control cases
Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02099318
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Nicholas C Bambakidis, MD||University Hospital Case Medical Center|