Fluorescent Evaluation of Colorectal Anastamoses

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2015 by Danny A Sherwinter, Maimonides Medical Center.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Danny A Sherwinter, Maimonides Medical Center

ClinicalTrials.gov Identifier:

NCT01424293

First received: September 29, 2010

Last updated: August 6, 2015

Last verified: August 2015

History of Changes

Purpose

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	Intervention
Rectal Neoplasms Colon Neoplasms Diverticulitis	Device: Indocyanine Green Device: The SPY® Intraoperative Imaging System


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label)
Official Title:	The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion

Resource links provided by NLM:

MedlinePlus related topics: Diagnostic Imaging

Drug Information available for: Indocyanine green

U.S. FDA Resources

Further study details as provided by Danny A Sherwinter, Maimonides Medical Center:

Primary Outcome Measures:

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


Estimated Enrollment:	120
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)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424293

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


Responsible Party:	Danny A Sherwinter, Attending Physician, Surgery, Maimonides Medical Center
ClinicalTrials.gov Identifier:	NCT01424293 History of Changes
Other Study ID Numbers:	1004va09
Study First Received:	September 29, 2010
Last Updated:	August 6, 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

ClinicalTrials.gov processed this record on September 21, 2017

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