Clinical trial NCT00671203: Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Official title: Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Ischemia
Aortic Aneurysm
Keywords: Tissue oximetry
Ischemia
Aortic Aneurysm Repair
Aortic Stent
Vascular Stent
Aortic graft
Vascular graft
Lead sponsor: Spectros Corporation
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
name: University of California
First posted: 2008-05-05
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable.

This purpose of this study is to establish how T-Stat can best be used to prevent deaths.


Eligibility criteria: Inclusion Criteria:

* Aortic Aneurysm, intact or ruptured
* Repair by catheter based stent or by open surgery during monitoring
* Patent rectum
* Absence of rectal bleeding

Exclusion Criteria:

* Lack of informed consent
* Rectal bleeding
* Obstructed rectum

Primary outcomes:
measure: Detect colon ischemia early
timeFrame: Just before, and during, surgery or stenting
Secondary outcomes:
measure: Allows change in the untreated course of colon ischemia
timeFrame: 28 days or discharge from hospital
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California at Davis Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Vascular Surgery
state: California
Study officials:
References:
citation: Friedland S, Benaron D, Coogan S, Sze DY, Soetikno R. Diagnosis of chronic mesenteric ischemia by visible light spectroscopy during endoscopy. Gastrointest Endosc. 2007 Feb;65(2):294-300. doi: 10.1016/j.gie.2006.05.007. Epub 2006 Sep 20.
citation: Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. doi: 10.1097/00000542-200406000-00019.
citation: Lee ES, Bass A, Arko FR, Heikkinen M, Harris EJ, Zarins CK, van der Starre P, Olcott C. Intraoperative colon mucosal oxygen saturation during aortic surgery. J Surg Res. 2006 Nov;136(1):19-24. doi: 10.1016/j.jss.2006.05.014. Epub 2006 Sep 15.
citation: Lee ES, Pevec WC, Link DP, Dawson DL. Use of T-Stat to predict colonic ischemia during and after endovascular aneurysm repair: a case report. J Vasc Surg. 2008 Mar;47(3):632-4. doi: 10.1016/j.jvs.2007.09.037.