Patient-Reported Bowel, Urinary and Sexual Outcomes After Laparoscopic-Assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial (ALaCart)

To compare patient-reported urinary, bowel and sexual functioning of ALaCaRT Trial participants randomised to Open or Laparoscopic surgery for rectal cancer.The primary endpoint, non-inferiority of laparoscopic surgical resection adequacy, was not established.Participants completed QLQ-CR29 at baseline, three and 12-months post-surgery. Additionally, women completed Rosen's Female Sexual Functioning Index (FSFI).Men completed the International Index of Erectile Function (IIEF) and QLQ-PR25.We compared the proportions of participants in each group who experienced moderate/severe symptoms/dysfunction at each time-point and compared mean difference scores from baseline to 12 months between groups. All analyses were intention-to-treat. Sexual functioning analyses included only the participants who expressed sexual interest at baseline.Baseline PRO compliance of 475 randomised participants was 88%. At 12 months, a lower proportion of Open surgery participants experienced moderate-severe faecal incontinence and sore skin, compared to Laparoscopic participants, and a lower proportion of men randomised to Open surgery experienced moderate-severe urinary symptoms. There were no differences at three months for bowel or urinary symptoms.Sexual functioning among sexually interested participants was similar between groups at three and 12 months, however a lower proportion of women reported moderate to severe sexual dissatisfaction at three months in the Open (p[Combining Circumflex Accent]1 = 0.31) as compared to the Laparoscopic (p[Combining Circumflex Accent]2 = 0.52) group, (p[Combining Circumflex Accent]2-p[Combining Circumflex Accent]1 = 0.21,95%CI 0.03,0.39).Despite the slightly lower proportions of Open surgery participants self-reporting moderate-severe symptoms for three of 16 urinary/bowel domains, and lack of differences in sexual domains, it remains difficult to recommend one surgical approach over another for rectal resection.