Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair
Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03429647
Collaborator
(none)
20
1
60
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair
Actual Study Start Date
:
Jan 1, 2013
Actual Primary Completion Date
:
Dec 31, 2016
Actual Study Completion Date
:
Jan 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Sigmoid perfusion Measured by visible light spectroscopy |
Diagnostic Test: visible light spectroscopy
Sigmoid perfusion was assessed using visible light spectroscopy
|
Outcome Measures
Primary Outcome Measures
- saturation in the sigmoid colon [intraoperative day]
Perfusion rate
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- undergoing elective open AAA repair between 2013 and 2016 were eligible for this study
Exclusion Criteria:
-
No informed consent
-
emergency cases
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Jasmin Zeindler, MD, University Hospital, Basel, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03429647
Other Study ID Numbers:
- EK 316/12
First Posted:
Feb 12, 2018
Last Update Posted:
Mar 7, 2018
Last Verified:
Mar 1, 2018
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
Additional relevant MeSH terms: