METHODS: Adults with cT1-4a Nx M0 rectal adenocarcinoma within 10 cm of the anal verge were randomized 1 : 1 to L-TME or R-TME at three Korean tertiary centres between July 2011 and February 2016. Pre-specified secondary endpoints were 5-year overall, relapse-free, local recurrence-free, and distant recurrence-free survival. Analyses were on a modified intention-to-treat basis.
RESULTS: Of 295 analysed patients (144 L-TME patients and 151 R-TME patients; median follow-up of 72.6 months), 5-year overall survival (92.6% versus 92.4%; P = 0.838) and relapse-free survival (81.9% versus 83.0%; P = 0.801) were similar. Local recurrence occurred in 4.9% (L-TME) and 1.3% (R-TME); 5-year local recurrence-free and distant recurrence-free survival did not differ (P = 0.076 and P = 0.655). In a post-hoc analysis of 146 patients who received neoadjuvant chemoradiotherapy, 5-year local recurrence-free survival was 98.6% in R-TME patients versus 90.7% in L-TME patients (P = 0.039).
CONCLUSION: R-TME and L-TME produced equivalent 5-year oncological outcomes. A post-hoc analysis suggested improved local control with robotic surgery after neoadjuvant chemoradiotherapy, requiring confirmation in prospectively designed studies.
REGISTRATION NUMBER: NCT01423214 (http://www.clinicaltrials.gov).
METHOD: A modified Delphi approach with three rounds of questionnaire was adopted. A total of 29 international experts from 11 countries were recruited for this study. Six domains with a total of 37 statements were examined, including anatomical definition; definition of intersphincteric dissection, intersphincteric resection (ISR) and ultra-low anterior resection (uLAR); indication for ISR; surgical technique of ISR; specimen description of ISR; and functional outcome assessment protocol.
RESULTS: Three rounds of questionnaire were performed (response rate 100%, 89.6%, 89.6%). Agreement (≥80%) reached standardization on 36 statements.
CONCLUSION: This study provides an international expert consensus-based definition and standardization of ISR. This is the first study standardizing terminology and definition of deep pelvis/anal canal anatomy from a surgical point of view. Intersphincteric dissection, ISR and uLAR were specifically defined for precise surgical description. Indication for ISR was determined by the rectal tumour's maximal radial infiltration (T stage) below the levator ani. A new surgical definition of T3isp was reached by consensus to define T3 low rectal tumours infiltrating the intersphincteric plane. A practical flowchart for surgical indication for uLAR/ISR/abdominoperineal resection was developed. A standardized ISR surgical technique and functional outcome assessment protocol was defined.