Fluorescent Evaluation of Colorectal Anastamoses
This study is ongoing, but not recruiting participants.
Sponsor:
Maimonides Medical Center
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
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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: 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: | 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) |
| 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
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
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 |
| 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:
|
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 30, 2016