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)
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. The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established. Participants...
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| Veröffentlicht in: | Annals of surgery 2023-03, Vol.277 (3), p.449-455 |
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| creator | Mercieca-Bebber, Rebecca Eggins, Renee Brown, Killian Gebski, Val J. Brewer, Kate Lai, Lenna Bailey, Lisa Solomon, Michael J. Lumley, John W. Hewett, Peter Clouston, Andrew D. Wilson, Kate Hague, Wendy Hayes, Julian White, Stephen Morgan, Matt Simes, John Stevenson, Andrew R. L. |
| description | 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.
The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established.
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.
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).
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. |
| doi_str_mv | 10.1097/SLA.0000000000005412 |
| format | Article |
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The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established.
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.
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).
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.</description><identifier>ISSN: 0003-4932</identifier><identifier>EISSN: 1528-1140</identifier><identifier>DOI: 10.1097/SLA.0000000000005412</identifier><identifier>PMID: 35166265</identifier><language>eng</language><publisher>United States: Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Female ; Humans ; Laparoscopy ; Male ; Patient Reported Outcome Measures ; Proctectomy - adverse effects ; Rectal Neoplasms - surgery ; Rectum - surgery</subject><ispartof>Annals of surgery, 2023-03, Vol.277 (3), p.449-455</ispartof><rights>Wolters Kluwer Health, Inc. All rights reserved.</rights><rights>Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3010-ce03a69203c220bf6d6c26f76be8935dc6d81e440cb47cfd56ebfa2ab7152323</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35166265$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mercieca-Bebber, Rebecca</creatorcontrib><creatorcontrib>Eggins, Renee</creatorcontrib><creatorcontrib>Brown, Killian</creatorcontrib><creatorcontrib>Gebski, Val J.</creatorcontrib><creatorcontrib>Brewer, Kate</creatorcontrib><creatorcontrib>Lai, Lenna</creatorcontrib><creatorcontrib>Bailey, Lisa</creatorcontrib><creatorcontrib>Solomon, Michael J.</creatorcontrib><creatorcontrib>Lumley, John W.</creatorcontrib><creatorcontrib>Hewett, Peter</creatorcontrib><creatorcontrib>Clouston, Andrew D.</creatorcontrib><creatorcontrib>Wilson, Kate</creatorcontrib><creatorcontrib>Hague, Wendy</creatorcontrib><creatorcontrib>Hayes, Julian</creatorcontrib><creatorcontrib>White, Stephen</creatorcontrib><creatorcontrib>Morgan, Matt</creatorcontrib><creatorcontrib>Simes, John</creatorcontrib><creatorcontrib>Stevenson, Andrew R. L.</creatorcontrib><title>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)</title><title>Annals of surgery</title><addtitle>Ann Surg</addtitle><description>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.
The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established.
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.
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).
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.</description><subject>Female</subject><subject>Humans</subject><subject>Laparoscopy</subject><subject>Male</subject><subject>Patient Reported Outcome Measures</subject><subject>Proctectomy - adverse effects</subject><subject>Rectal Neoplasms - surgery</subject><subject>Rectum - surgery</subject><issn>0003-4932</issn><issn>1528-1140</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkdtu1DAURS1ERYfCHyDkxyKR4kviJLylEZdKkQZNh-fIcU40BicOtqMB_pP_waOZXsAPtnW09zr22Qi9ouSKkjJ_d9tUV-TRylLKnqAVzViRUJqSp2gVqzxJS87O0XPvvxFC04Lkz9A5z6gQTGQr9OeLDBqmkGxgti5Aj6_tHsxb_NXpSbpfWE49voWfizR4vQRlR_C4GgI43MhZOuuVnbVKKu-1P9g34EEFbSdsHV7PMD2qDLG0iffIquWkwL3H2x3gavHBSSO9ltM_1JMK2wGHqDtYlxFv4pPsqH_HZrXRk1YRt3U67pdVI2vpwpsX6GyQxsPL03mBth8_bOvPSbP-dFNXTaI4oSRRQLgUJSNcMUa6QfRCMTHkooOi5FmvRF9QSFOiujRXQ58J6AbJZJfHKXPGL9DlETs7-2MBH9pRewXGyAns4lsmWEmyMuciStOjVMXPeQdDOzs9xgG3lLSHPNuYZ_t_ntH2-tRh6Ubo7013AT5w99bEUPx3s-zBtTuQJuyOPJEVSXlHTUpOCsL_AiLDrhY</recordid><startdate>20230301</startdate><enddate>20230301</enddate><creator>Mercieca-Bebber, Rebecca</creator><creator>Eggins, Renee</creator><creator>Brown, Killian</creator><creator>Gebski, Val J.</creator><creator>Brewer, Kate</creator><creator>Lai, Lenna</creator><creator>Bailey, Lisa</creator><creator>Solomon, Michael J.</creator><creator>Lumley, John W.</creator><creator>Hewett, Peter</creator><creator>Clouston, Andrew D.</creator><creator>Wilson, Kate</creator><creator>Hague, Wendy</creator><creator>Hayes, Julian</creator><creator>White, Stephen</creator><creator>Morgan, Matt</creator><creator>Simes, John</creator><creator>Stevenson, Andrew R. 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L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>Annals of surgery</jtitle><addtitle>Ann Surg</addtitle><date>2023-03-01</date><risdate>2023</risdate><volume>277</volume><issue>3</issue><spage>449</spage><epage>455</epage><pages>449-455</pages><issn>0003-4932</issn><eissn>1528-1140</eissn><abstract>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.
The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established.
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.
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).
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.</abstract><cop>United States</cop><pub>Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>35166265</pmid><doi>10.1097/SLA.0000000000005412</doi><tpages>7</tpages></addata></record> |
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| source | MEDLINE; PubMed Central; Journals@Ovid Complete |
| subjects | Female Humans Laparoscopy Male Patient Reported Outcome Measures Proctectomy - adverse effects Rectal Neoplasms - surgery Rectum - surgery |
| title | 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) |
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