Fluorescent Evaluation of Colorectal Anastamoses

NCT01424293 | Completed Results

• 1 other identifier: 1004va09
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Neoplasms; Colon Neoplasms; Diverticulitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the Vascular Supply of the Bowel Intra-operatively and Correlate This With Postoperative Complications Identified During Their Hospital Stay at One Week and One Month Postoperatively.

  Intra-operative evaluation of bowel perfusion. Participants will be followed for the duration of hospital stay and then at 1 week and 1 month postoperatively to identify postoperative complications.

  30 days

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

1ml of intravenous ICG and imaging transanally using the Spyscope system

Device: Indocyanine Green; Device: The SPY® Intraoperative Imaging System

Interventions

Indocyanine Green DEVICE

1ml of intravenous ICG and imaging transanally using the Spyscope system

Indocyanine Green

The SPY® Intraoperative Imaging System DEVICE

Indocyanine Green

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms; Colonic Neoplasms; Diverticulitis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Diverticular Diseases; Gastroenteritis

Results Point of Contact

• Title: Danny Sherwinter
• Organization: Maimonides Medical Center

dsherwinter@maimonidesmed.org

7182837952

Study Officials

• Danny Sherwinter, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Surgery

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: August 26, 2011
• Study Start: May 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Locations

US (1)