NCT03429647

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

January 26, 2018

Last Update Submit

March 6, 2018

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • saturation in the sigmoid colon

    Perfusion rate

    intraoperative day

Study Arms (1)

Sigmoid perfusion

OTHER

Measured by visible light spectroscopy

Diagnostic Test: visible light spectroscopy

Interventions

visible light spectroscopyDIAGNOSTIC_TEST

Sigmoid perfusion was assessed using visible light spectroscopy

Sigmoid perfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • No informed consent
  • emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jasmin Zeindler, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 12, 2018

Study Start

January 1, 2013

Primary Completion

December 31, 2016

Study Completion

January 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03