Long-term Survival and Functional Outcomes of Laparoscopic Surgery for Clinical Stage i Ultra-low Rectal Cancers Located Within 5 cm of the Anal Verge: A Prospective Phase II Trial (Ultimate Trial)

Objective: To clarify the long-term oncological outcomes and postoperative anal, urinary, and sexual functions after laparoscopic surgery for clinical stage I very low rectal carcinoma located near the anal canal. Background: Laparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared with open surgery. Methods: This single-arm, phase II trial included patients registered preoperatively from 47 institutions in Japan. The planned sample size was 300. The primary end point was the 3-year local recurrence rate. Anal, urinary, and sexual functions were evaluated using a prospective questionnaire. Results: Three hundred patients were registered between January 2014 and March 2017. Anus-preserving surgery was performed in 278 (93%), including 172 who underwent intersphincteric resection (58%) and 106 (36%) who underwent low anterior resection. The 3-year cumulative local recurrence rate was 6.3%. At 3 years postoperatively, 87% of patients used their own anus, and the median incontinence score improved from 12 at 3 months to 8 at 3 years. Only 5% of patients had severe incontinence (incontinence score of 16 points). Postoperative urinary function evaluation showed that the International Prostate Symptom Score and Overactive Bladder Symptom Score decreased 1 week after surgery but recovered to preoperative level 1 month after surgery. International Consultation on Incontinence Questionnaire-Sort Form remained almost stable after surgery. Sexual function evaluation using the International Index of Erectile Function-5 and International Index of Erectile Function-15 revealed that the patients had deteriorated 3 months after surgery but had recovered only slightly by 6 months. Conclusions: Laparoscopic surgery achieves feasible long-term oncological outcomes and a high rate of anus preservation with moderate anal function and an acceptable incontinence score. While urinary function recovered rapidly, sexual function showed poor recovery.