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)

被引:11
作者
Mercieca-Bebber, Rebecca [1 ,2 ]
Eggins, Renee [1 ,2 ]
Brown, Kilian [3 ]
Gebski, Val J. [1 ,2 ]
Brewer, Kate [2 ]
Lai, Lenna [1 ,2 ]
Bailey, Lisa [1 ,2 ]
Solomon, Michael J. [3 ]
Lumley, John W. [4 ]
Hewett, Peter [5 ]
Clouston, Andrew D. [6 ,7 ]
Wilson, Kate [1 ,2 ]
Hague, Wendy [1 ,2 ]
Hayes, Julian [8 ]
White, Stephen [9 ,10 ]
Morgan, Matt [11 ,12 ,13 ]
Simes, R. John [1 ,2 ]
Stevenson, Andrew R. L. [1 ,6 ]
机构
[1] Univ Sydney, NHMRC Clin Trials Ctr, Sydney, NSW, Australia
[2] Univ Sydney, Royal Prince Alfred Hosp, Australasian Gastrointestinal Trials Grp, Sydney, NSW, Australia
[3] Univ Sydney, Royal Prince Alfred Hosp, Inst Acad Surg, Sydney, NSW, Australia
[4] Wesley Hosp, Brisbane, Qld, Australia
[5] Queen Elizabeth Hosp, Adelaide, SA, Australia
[6] Univ Queensland, Brisbane, Qld, Australia
[7] Royal Brisbane & Womens Hosp, Brisbane, Qld, Australia
[8] Auckland Hosp, Auckland, New Zealand
[9] John Flynn Hosp, Auckland, Qld, Australia
[10] Tweed Heads Hosp, Tweed Heads, NSW, Australia
[11] Bankstown Lidcombe Hosp, Sydney, NSW, Australia
[12] Prince Wales Private Hosp, Sydney, NSW, Australia
[13] Sydney South West Private Hosp, Sydney, NSW, Australia
基金
澳大利亚国家健康与医学研究理事会; 英国医学研究理事会;
关键词
clinical trial; laparoscopic surgery; laparoscopic-assisted rectal cancer resection; open rectal cancer resection; patient-reported outcomes; quality of life; rectal cancer; sexual functioning; OPEN SURGERY; TERM OUTCOMES; INDEX FSFI; LIFE;
D O I
10.1097/SLA.0000000000005412
中图分类号
R61 [外科手术学];
学科分类号
摘要
Objective: The 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 Data: The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established. Methods: Participants 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. Results: Baseline 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). Discussion: Despite 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.
引用
收藏
页码:449 / 455
页数:7
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