This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
347
John Muir Medical Center, Concord Campus
Concord, California, United States
Anastomotic Leak Rate
Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.
Time frame: Day 0 to Week 8 (+/- 2 weeks)
Rate of SPY Visualization and Tissue Perfusion
The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure
Time frame: Day 0 (Day of Surgery)
Incidence of Post-Operative Abscess Requiring Surgical Management
Rate of postoperative abscess requiring surgical management.
Time frame: Day 0 to Week 8 (+/- 2 weeks)
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