Clinical Trial: Surgical Theater's Surgery Rehearsal Platform
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Effort and Time Efficiency of Surgical Theater's Surgery Rehearsal Platform (SRP) for Cerebral Aneurysm Clipping Surgery
Brief Summary: 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.
Detailed Summary:
Overview: This study is a blinded, multicenter, randomized study comparing key effort and time variables in 20 prospective SRP cases to these same effort and time variables in 20 video recorded control neurosurgery cases. SRP and control cases will be randomly selected according to a predetermined alternating sequence.
Effort will be assessed as the number of clipping attempts and clip evaluations, as identified by a blinded, trained rater observing video recorded SRP neurosurgical cases and control neurosurgery cases. Time will be assessed as the time that the vessel was temporarily occluded as well as total microsurgical time.
To maximize the potential effects of the SRP platform on learning, cases in the protocol will be limited to those in which the Chief Neurosurgery Resident or Cerebrovascular Fellow performs a majority of the microsurgical dissection. Their participation in this study will be that of a researcher, not of a participant.
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. 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. Inclusion/exclusion criteria for SRP cases and control cases will define clinically similar patient groups. Only patients who, in the opinion of their physicians, qualify for the clipping procedure will be considered for this study. The purpose of this project is to determine if simulated practice for the surgeon prior to surgery using the SRP will lead to better effort and time eff
Sponsor: University Hospitals Cleveland Medical Center
Current Primary Outcome: 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).
Original Primary Outcome: Aneurysm Clip Time [ Time Frame: At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position ]
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).
Current Secondary Outcome: 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.
Original Secondary Outcome: 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 ]
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.
Information By: University Hospitals Cleveland Medical Center
Dates:
Date Received: March 18, 2014
Date Started: February 2013
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017
