Article Text
Abstract
Introduction Flap-based reconstruction after pelvic exenteration is associated with high rates of wound complications, partly due to impaired perfusion.
Description In this non-randomized phase II trial (NCT05071976), perfusion of pedicled flap-based reconstruction was evaluated using near-infrared (NIR) angiography following pelvic exenteration. The primary endpoint was percentage of patients in whom 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. Among 15 patients, 10 (66.7%) underwent total, 3 (20.0%) underwent posterior, and 2 (13.3%) underwent anterior pelvic exenteration. All patients underwent reconstruction with a vertical rectus abdominis myocutaneous flap. Changes in intraoperative flap reconstruction management based on NIR angiography findings occurred in 8 patients (53.3%), including trimming poorly perfused areas (n=7) and abandoning the flap (n=1). Surgeons were consistently able to discriminate between areas of maximal and least perfusion, as measured by NIH Image J calculated pixilation. Two patients (13.3%) experienced a 30-day postoperative wound complication—both grade 2 complications of necrosis. In this small sample size, the 2 patients who experienced necrosis had lower median global flap perfusion at 60 seconds (43.6, IQR: 26.2-61.1) compared to patients who did not experience postoperative necrosis (100.2, IQR: 92.9-111.3) (P=0.036).
Conclusion/Implications Introduction of NIR angiography after flap-based reconstruction led to altered intraoperative management in 53.3% of patients, meeting the study’s primary endpoint. Our findings can inform future randomized controlled trials investigating if this technology improves postoperative outcomes.