Cerebral Aneurysm Unruptured Clinical Trial
Official title:
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.
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 efficiency. Findings will be used to inform development of a larger
and more rigorous trial of the SRP if the preliminary results are promising.
Inclusion/exclusion criteria are as follows:
Inclusion criteria:
- Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the
anterior circulation for which craniotomy and microsurgery is recommended
- Patients scheduled to undergo surgery for clipping of a cerebral aneurysm
- Able to provide written informed consent
Exclusion criteria:
- Repeat of aneurysm surgery
- Previous history of craniotomy for any reason
- Previous history of non-aneurysmal hemorrhagic stroke
- Pregnancy
- Posterior circulation
- Giant (25 mm or larger) aneurysm
- Nonsaccular aneurysm
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.
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.
Surgical care: All surgical procedures will be done according to standard of care. Except
for presurgical rehearsal, it is expected that surgical procedures between historical cases
and the SRP will not differ. All care received after the surgery will be routine care.
Research procedures and measures
Prior to embarking on the proposed study, PI will assign a blinded reviewer who will review
the video record of all cases from both enrolling sites. This blinded reviewer will be a
fully trained neurosurgeon not otherwise affiliated with the study. The reviewer will
undergo a period of training whereby he or she will review a cohort of recorded aneurysm
cases (not affiliated with the current study) in consultation with the primary investigator
and co-investigators until such time that agreement is reached regarding the method of
evaluation of outcome measures. Following training of the blinded reviewer, the study will
proceed as follows:
1. Patient recruitment utilizing inclusion/exclusion criteria, including collection of
demographic and clinical patient data and aneurysm characteristics.
2. All surgeries will be videotaped consistently with current procedures. All videotaping
will consist of microsurgical techniques; no subject or neurosurgery resident
identifying information will be revealed.
3. Blinded evaluators will view videotapes after all surgeries have been completed and
will evaluate cases using the outcome measures previously described.
Subjects
Subjects will be patients admitted for surgery for clipping of cerebral aneurysm.
Recruitment
Study Population. Two centers throughout the US will screen and identify 60 subjects with
unruptured or ruptured cerebral aneurysm. Patients will be identified and recruited through
site emergency departments, clinical stroke services, and direct admissions to the
neurological ICUs.
Case selection
It must be acknowledged that a prospectively collected control comparison does not ensure
lack of bias that will lead to group differences in neurosurgical procedures between
prospectively done SRP cases and controls cases. In an effort to standardize group
comparisons, the control and SRP cases will all be selected on the same time period and from
the practice of the surgical PI and co-investigators. The PI and surgical co-investigator
are experienced neurosurgeons who are experts in cerebral aneurysm clipping surgery.
Additionally, the control cohort and SRP cohort will be obtained in a consecutive manner
beginning with the implementation of the study to minimize potential selection bias and in a
manner representative of the clinical practice. The investigators will also attempt to
standardize the groups, including individuals that have similar clinical and demographic
characteristics.
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