Surgical Theater's Surgery Rehearsal Platform (SRP)
|ClinicalTrials.gov Identifier: NCT02099318|
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Aneurysm Unruptured Cerebral Aneurysm Ruptured||Other: Active SRP cases Other: Control cases||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal Platform (SRP) for Cerebral Aneurysm Clipping Surgery|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
- Aneurysm Clip Time [ Time Frame: At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes) ]
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 (minutes/seconds) from first clip to contact aneurysm to final clip placement ]
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 ]
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 ]
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 (minutes/seconds) from first aneurysm clip attempt to final clip placement ]Number of of aneurysm clips wasted according to OR records.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099318
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Nicholas C Bambakidis, MD||University Hospitals Cleveland Medical Center|