An observational study in Postoperative Complications and Postoperative Cognitive Dysfunction, sponsored by Ohio State University. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Ohio State University · Observational
This study may determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Medical records will be accessed to find any information pertaining to postoperative complications. Additionally, it may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental Status Examination (MMSE).
This is a multicenter prospective observational study; data will be collected from two sites: the lead site in Columbus, Ohio, USA and an international site in Girona, Spain for a total of 354 patients. The objective of this study is to determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Patients who undergo CEA are at increased risk of cardiovascular complications because of the high incidence of coexisting heart disease, high blood pressure, and diabetes. Common complications that occur after CEA are wound hematoma (collection of blood at the wound) and intracerebral hemorrhage (bleeding in the brain). Medical records will be accessed to find any information pertaining to postoperative complications. Another objective of this study is to determine the cognitive dysfunction of patients undergoing CEA. This will be measured by a Mini Mental Status Examination (MMSE) which will occur in person before the surgery and 30 days after the surgery over the phone. This study may provide data that will help identify how to optimize recovery for future CEA patients.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 10 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Patients 18 years of age or older scheduled to undergo carotid endarterectomy
Exclusion Criteria:
patients undergoing carotid endarterectomy
Procedure: Carotid endarterectomy · Diagnostic Test: Mini Mental Status Examination
Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)
Also known as: CAE
Short questionnaire used to diagnose cognitive dysfunction
Also known as: MMSE
Complication rate
Incidence of postoperative complications and identify the associated risk factors.
Time frame: 30 days
Cognitive Dysfunction
the incidence of cognitive dysfunction based on Mini Mental Status Examination
Time frame: 30 days
Plan to share: No — The de-identified date from the international site and the data collected at the main site will be analyzed at The Ohio State University Wexner Medical Center.
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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