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

March 6, 2018 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing elective open AAA repair between 2013 and 2016 were eligible for this study

Exclusion Criteria:

  • No informed consent
  • emergency cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sigmoid perfusion
Measured by visible light spectroscopy
Diagnostic test: visible light spectroscopy
Sigmoid perfusion was assessed using visible light spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
saturation in the sigmoid colon
Time Frame: intraoperative day
Perfusion rate
intraoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Jasmin Zeindler, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 316/12

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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