Trial record 2 of 4 for:    diverticulitis | Open Studies | United States

Fluorescent Evaluation of Colorectal Anastamoses

This study is currently recruiting participants.
Verified May 2013 by Maimonides Medical Center
Sponsor:
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01424293
First received: September 29, 2010
Last updated: May 25, 2013
Last verified: May 2013
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    Perioperative evaluation bowel perfusion


Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Indocyanine Green Device: Indocyanine Green
1ml of intravenous ICG and imaging transanally using the Spyscope system
Other Name: Indocyanine green

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424293

Contacts
Contact: Danny A Sherwinter, MD 7182837952 dsherwinter@maimonidesmed.org

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Sub-Investigator: James Gallagher, MD         
Sub-Investigator: Thomas Donkar, DO         
Sponsors and Collaborators
Maimonides Medical Center
  More Information

No publications provided

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: May 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:
Rectal Cancer
Colon Cancer
Diverticulitis
Anastamosis
colectomy
low anterior resection

Additional relevant MeSH terms:
Diverticulitis
Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Gastroenteritis
Rectal Diseases

ClinicalTrials.gov processed this record on April 16, 2014