• 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 StevensonAndrew R LARLNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.University of Queensland, Brisbane, Queensland, Australia..
• NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
• Ann. Surg. 2023 Mar 1; 277 (3): 449455449-455.

ObjectiveThe aim of this study was to compare patient-reported urinary, bowel, and sexual functioning of ALaCaRT Trial participants randomized to open or laparoscopic surgery for rectal cancer.Summary Background DataThe primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established.MethodsParticipants completed QLQ-CR29 at baseline, 3, 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.ResultsBaseline PRO compliance of 475 randomized participants was 88%. At 12 months, a lower proportion of open surgery participants experienced moderate-severe fecal incontinence and sore skin, compared to Laparoscopic participants, and a lower proportion of men randomized to open surgery experienced moderate-severe urinary symptoms. There were no differences at 3 months for bowel or urinary symptoms. Sexual functioning among sexually interested participants was similar between groups at 3 and 12 months; however, a lower proportion of women reported moderate to severe sexual dissatisfaction at 3 months in the open as compared to the laparoscopic group, (Rebecca.mercieca@sydney.edu.au., 95% CI 0.03-0.39).DiscussionDespite the slightly lower proportions of open surgery participants self-reporting moderate-severe symptoms for 3 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.Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

16 keywords...

hide…