S Saito1, S Fujita2, J Mizusawa3, Y Kanemitsu4, N Saito5, Y Kinugasa6, Y Akazai7, M Ota8, M Ohue9, K Komori10, M Shiozawa11, T Yamaguchi12, T Akasu13, Y Moriya14. 1. Division of Surgery, Gastrointestinal Center, Yokohama Shin-Midori General Hospital, 1726-7, Tokaichiba-cho, Midori-ku, Yokohama 226-0025, Japan. Electronic address: shusaito@jb3.so-net.ne.jp. 2. Department of Surgery, Tochigi Cancer Center, 4-9-13, Yonan, Utsunomiya 320-0834, Japan. Electronic address: sifujita@tochigi-cc.jp. 3. JCOG Data Center, National Cancer Center, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: jmizusaw@ncc.go.jp. 4. Colorectal Surgery Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: ykanemit@ncc.go.jp. 5. Department of Surgery, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. Electronic address: norsaito@east.ncc.go.jp. 6. Department of Surgery, Shizuoka Cancer Center, 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan. Electronic address: y.kinugasa@scchr.jp. 7. Department of Surgery, Okayama Saiseikai General Hospital, 1-17-18, Ifuku-cho, Kita-ku, Okayama 700-8511, Japan. Electronic address: s.gekaaz@gmail.com. 8. Department of Surgery, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. Electronic address: m_ota@yokohama-cu.ac.jp. 9. Department of Surgery, Osaka Medical Center and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka 537-8511, Japan. Electronic address: ohue-ma@mc.pref.osaka.jp. 10. Department of Surgery, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. Electronic address: kkomori@aichi-cc.jp. 11. Department of Surgery, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama 241-8515, Japan. Electronic address: shiozawam@kcch.jp. 12. Department of Surgery, National Hospital Organization Kyoto Medical Center, 1-1, Kusafukamukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan. Electronic address: tayamagu@kyotolan.hosp.go.jp. 13. The Imperial Household Agency Hospital, 1-2, Chiyoda, Chiyoda-ku, Tokyo 100-0001, Japan. Electronic address: akasu@msf.biglobe.ne.jp. 14. Department of Surgery, Miki Hospital, 100 Ushizawauwano, Kojo, Maesawa-ku, Oushu, Iwate 029-4201, Japan. Electronic address: y.y.moriya@nifty.com.
Abstract
BACKGROUND: We conducted a randomized controlled trial (JCOG0212) to determine whether the outcome of mesorectal excision (ME) alone for rectal cancer is not inferior to that of ME with lateral lymph node dissection (LLND). The present study focused on male sexual dysfunction after surgery. METHODOLOGY: Eligibility criteria included clinical stage II/III rectal cancer, the lower margin of the lesion below the peritoneal reflection, the absence of lateral pelvic lymph node enlargement, and no preoperative radiotherapy. After confirmation of R0 resection by ME, patients were intraoperatively randomized. Questionnaires using the International Index of Erectile Function (IIEF-5) about the sexual function of men were collected before and 1 year after surgery. Sexual dysfunction incidence was defined as the ratio of patients showing sexual dysfunction after surgery relative to the number who had no erectile dysfunction before surgery. RESULTS: Among 701 patients enrolled between June 2003 and August 2010, 472 males were included. Among them, 343 (73%) completed preoperative and postoperative questionnaires. According to the study protocol, the incidences of sexual dysfunction in patients who underwent ME alone and ME with LLND were 68% (17/25; 95%CI, 47-85%) and 79% (23/29; 95%CI, 60-92%), respectively (p = 0.37). Incidences of sexual dysfunction in patients with no or only mild erectile dysfunction before surgery who underwentME alone and ME with LLND were 59% (48/81) and 71% (67/95), respectively (p = 0.15). Multivariate analysis identified age as the only risk factor for sexual dysfunction after surgery (p = 0.02). CONCLUSIONS:LLND may not increase sexual dysfunction incidenceafter rectal cancer surgery. This incidence is associated with increased age. This trial is registered with ClinicalTrials.gov, number NCT00190541 and University Hospital Medical Information Network Clinical Trials Registry, number C000000034.
RCT Entities:
BACKGROUND: We conducted a randomized controlled trial (JCOG0212) to determine whether the outcome of mesorectal excision (ME) alone for rectal cancer is not inferior to that of ME with lateral lymph node dissection (LLND). The present study focused on male sexual dysfunction after surgery. METHODOLOGY: Eligibility criteria included clinical stage II/III rectal cancer, the lower margin of the lesion below the peritoneal reflection, the absence of lateral pelvic lymph node enlargement, and no preoperative radiotherapy. After confirmation of R0 resection by ME, patients were intraoperatively randomized. Questionnaires using the International Index of Erectile Function (IIEF-5) about the sexual function of men were collected before and 1 year after surgery. Sexual dysfunction incidence was defined as the ratio of patients showing sexual dysfunction after surgery relative to the number who had no erectile dysfunction before surgery. RESULTS: Among 701 patients enrolled between June 2003 and August 2010, 472 males were included. Among them, 343 (73%) completed preoperative and postoperative questionnaires. According to the study protocol, the incidences of sexual dysfunction in patients who underwent ME alone and ME with LLND were 68% (17/25; 95%CI, 47-85%) and 79% (23/29; 95%CI, 60-92%), respectively (p = 0.37). Incidences of sexual dysfunction in patients with no or only mild erectile dysfunction before surgery who underwent ME alone and ME with LLND were 59% (48/81) and 71% (67/95), respectively (p = 0.15). Multivariate analysis identified age as the only risk factor for sexual dysfunction after surgery (p = 0.02). CONCLUSIONS: LLND may not increase sexual dysfunction incidence after rectal cancer surgery. This incidence is associated with increased age. This trial is registered with ClinicalTrials.gov, number NCT00190541 and University Hospital Medical Information Network Clinical Trials Registry, number C000000034.
Authors: Tania C Sluckin; Sanne-Marije J A Hazen; Karin Horsthuis; Regina G H Beets-Tan; Corrie A M Marijnen; Pieter J Tanis; Miranda Kusters Journal: Insights Imaging Date: 2022-10-20