Patient Reported Outcomes following Cancer of the Rectum (PROCaRe): protocol of a prospective multicentre international study

Purpose: Rectal cancer surgery presents challenges in achieving good oncological results and preserving functional outcomes. Different surgical approaches, including open, laparoscopic, robotic and transanal techniques, have been employed, but there is a lack of consensus on the optimal approach, particularly in terms of functional results. This study aims to assess bowel function and to compare outcomes of patients that had undergone surgery for mid-low rectal cancer across different surgical approaches. Method: This is an international, multicentre, prospective cohort study. Inclusion criteria are patients diagnosed with rectal cancer below the peritoneal reflection, eligible for different surgical approaches for total mesorectal excision (TME). Data will be collected using validated questionnaires assessing bowel, sexual and urinary function, and quality of life (QOL). Secondary outcomes include short-term postoperative results. Data will be collected at baseline and 6, 12 and 24 months after index surgery or stoma reversal surgery. Conclusion: This study will provide insights into the impact of different approaches for TME on bowel, sexual and urinary function, and overall QOL of patients undergoing rectal cancer surgery. The findings will provide important information to optimise the surgical strategy and to improve patient care in this population. Trial registration: ClinicalTrials.gov, NCT04936581 (registered 23 June 2021).