N/A
N=7
Fluorescent Evaluation of Colorectal Anastamoses
Rectal Neoplasms · Colon Neoplasms · Diverticulitis
Bottom Line
View on ClinicalTrials.gov: NCT01424293 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: 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. — 0 Complications
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indocyanine Green (Device); The SPY® Intraoperative Imaging System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Maimonides Medical Center
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
— | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01424293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.