Fluorescent Evaluation of Colorectal Anastamoses

Completed · Not applicable

Conditions studied: Rectal Neoplasms, Colon Neoplasms, Diverticulitis

In brief

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

Key facts

Study ID

NCT01424293

Run by

Maimonides Medical Center

People needed

7

Starts

2010-05-01

Expected to finish

2016-09-01

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates for this study must meet ALL of the following inclusion criteria:
• Subject is willing and able to provide an informed consent
• Subject is willing and able to comply with the study procedures
• Subject speaks English and is able to understand the study procedures
• A pregnancy test for women of childbearing potential prior to surgery
• Subject is scheduled for laparoscopic low anterior resection

You may not qualify if…

• Candidates for this study who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
• Subject has uremia, serum creatinine >2.5 mg/dl
• Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
• Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
• Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
• Subject is a pregnant or lactating female
• Subject is actively participating in another drug, biologic and/or device protocol

Where it is running

• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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