Back to resultsIntraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
visible light spectroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- undergoing elective open AAA repair between 2013 and 2016 were eligible for this study
Exclusion Criteria:
- No informed consent
- emergency cases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sigmoid perfusion
Arm Description
Measured by visible light spectroscopy
Outcomes
Primary Outcome Measures
saturation in the sigmoid colon
Perfusion rate
Secondary Outcome Measures
Full Information
NCT ID
NCT03429647
First Posted
January 26, 2018
Last Updated
March 6, 2018
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03429647
Brief Title
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair
Official Title
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Blood supply to the sigmoid colon during open abdominal aortic aneurysm (AAA) repair is at risk. Ischemia of the sigmoid colon after AAA repair is potentially devastative. No reliable measures to prevent it are available and the underlying mechanisms are poorly understood. The aim of this study is to describe intraoperative perfusion patterns of the sigmoid colon during open AAA repair and their potential impact on postoperative outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sigmoid perfusion
Arm Type
Other
Arm Description
Measured by visible light spectroscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
visible light spectroscopy
Intervention Description
Sigmoid perfusion was assessed using visible light spectroscopy
Primary Outcome Measure Information:
Title
saturation in the sigmoid colon
Description
Perfusion rate
Time Frame
intraoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
undergoing elective open AAA repair between 2013 and 2016 were eligible for this study
Exclusion Criteria:
No informed consent
emergency cases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmin Zeindler, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair
We'll reach out to this number within 24 hrs