Introduction/Background Flap-based reconstruction following pelvic exenteration is associated with high rates of wound complications, partly due to impaired perfusion.

Methodology In this prospective, non-randomized trial (NCT05071976), we evaluated the use of near-infrared (NIR) angiography in pedicled flap-based reconstruction following pelvic exenteration. The primary endpoint was percentage of cases in which intraoperative NIR angiography led to a change in flap reconstruction management, calculated assuming binomial proportions, with a change in ≥13.3% of cases indicating the technology was worthy of additional investigation. A secondary endpoint was 30-day postoperative outcomes.

Results Fourteen patients were enrolled.

Median age was 56 years (range, 29–74). Patients underwent exenteration for cervical (n=8, 57%), rectal (n=3, 22%), vulvar (n=2, 14%), or endometrial (n=1, 7%) cancer. Seven patients (50%) were White non-Hispanic, 4 (29%) were White Hispanic, 2 (14%) were Black non-Hispanic, and 1 (7%) (n=1) was Asian. Median body mass index was 27.8 kg/m2 (range, 16.6–36.1). Three patients (22%) had a smoking history. All patients received prior chemotherapy and radiation.

Nine patients (64%) underwent total, 3 (22%) underwent posterior, and 2 (14%) underwent anterior pelvic exenteration. All patients underwent reconstruction with a vertical rectus abdominis myocutaneous flap. NIR angiography led to a change in intraoperative flap reconstruction management in 7 patients (50%), including trimming poorly perfused areas identified by NIR angiography in 6 patients and abandoning the pedicled flap in 1 patient after poor perfusion was identified by NIR angiography. Only 1 patient (7%) experienced a wound complication—a grade 2 complication of necrosis requiring bedside debridement and oral antibiotics.

Conclusion This prospective, non-randomized surgical trial demonstrated NIR angiography led to altered intraoperative flap reconstruction management in 50% of patients, meeting the study’s primary endpoint. Our findings can inform future randomized controlled trials investigating if this technology improves postoperative outcomes.