1. 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)
- Author
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Rebecca Mercieca-Bebber, Renee Eggins, Kilian Brown, Val J. Gebski, Kate Brewer, Lenna Lai, Lisa Bailey, Michael J. Solomon, John W. Lumley, Peter Hewett, Andrew D. Clouston, Kate Wilson, Wendy Hague, Julian Hayes, Stephen White, Matt Morgan, R. John Simes, and Andrew R. L. Stevenson
- Subjects
Surgery - Abstract
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.
- Published
- 2022