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This nonrandomized controlled trial evaluates the resection margin rates as well as the safety and usability of a newly developed image-guided navigation technique among patients who underwent a rectal cancer resection., Key Points Question Is there an association between image-guided navigation and complete surgical resection rates in locally advanced rectal cancer and recurrent rectal cancer? Findings In this nonrandomized controlled trial of 33 patients with locally advanced or recurrent rectal cancer, image-guided navigation was found to be a feasible and safe technique in advanced rectal cancer resection. Patients with recurrent cancer who underwent image-guided resection had higher rates of successful resection than a historical cohort who received resection without navigation; however, there was no difference between groups for patients with primary locally advanced cancer. Meaning Image-guided navigation appeared to be associated with an increase in radical resection margin rates in recurrent rectal cancer resection and thereby may improve patient outcomes., Importance The percentage of tumor-positive surgical resection margin rates in patients treated for locally advanced primary or recurrent rectal cancer is high. Image-guided navigation may improve complete resection rates. Objective To ascertain whether image-guided navigation during rectal cancer resection improves complete resection rates compared with surgical procedures without navigation. Design, Setting, and Participants This prospective single-center nonrandomized controlled trial was conducted at the Netherlands Cancer Institute—Antoni van Leeuwenhoek in Amsterdam, the Netherlands. The prospective or navigation cohort included adult patients with locally advanced primary or recurrent rectal cancer who underwent resection with image-guided navigation between February 1, 2016, and September 30, 2019, at the tertiary referral hospital. Clinical results of this cohort were compared with results of the historical cohort, which was composed of adult patients who received rectal cancer resection without image-guided navigation between January 1, 2009, and December 31, 2015. Intervention Rectal cancer resection with image-guided navigation. Main Outcomes and Measures The primary end point was the complete resection rate, measured by the amount of tumor-negative resection margin rates. Secondary outcomes were safety and usability of the system. Safety was evaluated by the number of navigation system–associated surgical adverse events. Usability was assessed from responses to a questionnaire completed by the participating surgeons after each procedure. Results In total, 33 patients with locally advanced or recurrent rectal cancer were included (23 men [69.7%]; median [interquartile range] age at start of treatment, 61 [55.0-69.0] years). With image-guided navigation, a radical resection (R0) was achieved in 13 of 14 patients (92.9%; 95% CI, 66.1%-99.8%) after primary resection of locally advanced tumors and in 15 of 19 patients (78.9%; 95% CI, 54.4%-94.0%) after resection of recurrent rectal cancer. No navigation system–associated complications occurred before or during surgical procedures. In the historical cohort, 142 patients who underwent resection without image-guided navigation were included (95 men [66.9%]; median [interquartile range] age at start of treatment, 64 [55.0-70.0] years). In these patients, an R0 resection was accomplished in 85 of 101 patients (84.2%) with locally advanced rectal cancer and in 20 of 41 patients (48.8%) with recurrent rectal cancer. A significant difference was found between the navigation and historical cohorts after recurrent rectal cancer resection (21.1% vs 51.2%; P = .047). For locally advanced primary tumor resection, the difference was not significant (7.1% vs 15.8%; P = .69). Surgeons stated in completed questionnaires that the navigation system improved decisiveness and helped with tumor localization. Conclusions and Relevance Findings of this study suggest that image-guided navigation used during rectal cancer resection is safe and intuitive and may improve tumor-free resection margin rates in recurrent rectal cancer. Trial Registration Netherlands Trial Register Identifier: NTR7184