Fluorescent Evaluation of Colorectal Anastamoses

Study Description

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Brief Summary:

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

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Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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 system Device: The SPY® Intraoperative Imaging System

Outcome Measures

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Primary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

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Locations

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219

Sponsors and Collaborators

Maimonides Medical Center

Investigators

Principal Investigator:	Danny Sherwinter, MD	Maimonides Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Danny A Sherwinter, Attending Physician, Surgery, Maimonides Medical Center
ClinicalTrials.gov Identifier:	NCT01424293 History of Changes
Other Study ID Numbers:	1004va09
First Posted:	August 26, 2011
Last Update Posted:	August 7, 2015
Last Verified:	August 2015

Keywords provided by Danny A Sherwinter, Maimonides Medical Center:

Rectal Cancer; Colon Cancer; Diverticulitis	Anastamosis; colectomy; low anterior resection

Additional relevant MeSH terms:

Neoplasms; Diverticulitis; Rectal Neoplasms; Colonic Neoplasms; Intraabdominal Infections; Infection; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases	Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Intestinal Diseases; Rectal Diseases; Colonic Diseases