A controlled study on the efficacy and quality of life of laparoscopic intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE) in the treatment of extremely low rectal cancer.

BACKGROUND The aim of this study is to compare the postoperative quality of life (QoL) and survival outcomes in lower rectal cancer (LRC) patients who undergo either laparoscopic- intersphincteric resection or extralevator abdominoperineal excision (L-ELAPE) after long-course neoadjuvant chemoradiation therapy (nCRT). METHODS This prospective, single-center, non-randomized, controlled, non-blinded, phase I/II clinical trial is designed to enroll 159 eligible LRC patients who achieved favorable response to long-course nCRT (2 × 25 Gy). After informed consent, the patients will be assigned into the laparoscopic intersphincteric resection group or L-ELAPE group according to their own will. Standard radical laparoscopic surgeries will be performed for every participant. Then every participant will be followed up for 3 years. The primary outcomes are scores of QoL questionnaire-core 30, QoL questionnaire-colorectum 29, Wexner incontinence score, International Prostate Symptom Score (for male), International Index of Erectile Function-5 (for male) and Female Sexual Function Index (for female). The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes. DISCUSSION This is the first prospective clinical controlled trial to assess postoperative QoL and efficacy for LRC patients after favorable long-course nCRT. The result is expected to provide new evidence for a more detailed individualized treatment guideline for LRC. TRIAL REGISTRATION This trial was registered at Chinese Clinical Trial Registry (ChiCTR1800017512; ChiCTR.org) on August 2, 2018.