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Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair

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ClinicalTrials.gov Identifier: NCT03429647
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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
Abdominal Aortic Aneurysm Diagnostic Test: visible light spectroscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Sigmoid perfusion
Measured by visible light spectroscopy
 Diagnostic Test: visible light spectroscopy
Sigmoid perfusion was assessed using visible light spectroscopy


Outcome Measures
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Primary Outcome Measures :
  1. saturation in the sigmoid colon [ Time Frame: intraoperative day ]
    Perfusion rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429647


Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Jasmin Zeindler, MD University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03429647    
Other Study ID Numbers: EK 316/12
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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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:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases