Fluorescent Evaluation of Colorectal Anastamoses
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
|Rectal Neoplasms Colon Neoplasms Diverticulitis||Device: Indocyanine Green Device: The SPY® Intraoperative Imaging System|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion|
- 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
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01424293
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Danny Sherwinter, MD||Maimonides Medical Center|