Fluorescent Evaluation of Colorectal Anastamoses
|ClinicalTrials.gov Identifier: NCT01424293|
Recruitment Status : Unknown
Verified August 2015 by Danny A Sherwinter, Maimonides Medical Center.
Recruitment status was: Active, not recruiting
First Posted : August 26, 2011
Last Update Posted : August 7, 2015
Bowel removal is indicated for various types of colon and rectal disease, including colon cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others.
Following removal of the diseased segment of bowel your surgeon will reconnect the two healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an extremely dangerous situation.
The cause of leakage has many causes and is not well understood, but appears to be at least in part due to not having enough blood going to the bowel. There is currently no way to evaluate the blood supply to the bowel.
The purpose of this study is to utilize a special camera to evaluate the blood supply of the bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing the occurrence of leaks
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms Colon Neoplasms Diverticulitis||Device: Indocyanine Green Device: The SPY® Intraoperative Imaging System||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Indocyanine Green
1ml of intravenous ICG and imaging transanally using the Spyscope system
Device: Indocyanine Green
1ml of intravenous ICG and imaging transanally using the Spyscope systemDevice: The SPY® Intraoperative Imaging System
- Evaluate the vascular supply to bowel anastomoses [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days and then in the clinic at one week and one month postoperatively ]Perioperative evaluation bowel perfusion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424293
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Danny Sherwinter, MD||Maimonides Medical Center|