title: Male sexual dysfunction after rectal cancer surgery: Results of a randomized trial comparing mesorectal excision with and without lateral lymph node dissection for patients with lower rectal cancer: Japan Clinical Oncology Group Study JCOG0212.
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.
  
  
  METHODS
  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: 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.
authors: S
authors: S
authors: Saito
authors: Department of Surgery, Tochigi Cancer Center, 4-9-13, Yonan, Utsunomiya 320-0834, Japan. Electronic address: sifujita@tochigi-cc.jp.
authors: S
authors: S
authors: Fujita
authors: JCOG Data Center, National Cancer Center, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: jmizusaw@ncc.go.jp.
authors: J
authors: J
authors: Mizusawa
authors: Colorectal Surgery Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: ykanemit@ncc.go.jp.
authors: Y
authors: Y
authors: Kanemitsu
authors: Department of Surgery, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. Electronic address: norsaito@east.ncc.go.jp.
authors: N
authors: N
authors: Saito
authors: Department of Surgery, Shizuoka Cancer Center, 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan. Electronic address: y.kinugasa@scchr.jp.
authors: Y
authors: Y
authors: Kinugasa
authors: Department of Surgery, Okayama Saiseikai General Hospital, 1-17-18, Ifuku-cho, Kita-ku, Okayama 700-8511, Japan. Electronic address: s.gekaaz@gmail.com.
authors: Y
authors: Y
authors: Akazai
authors: 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.
authors: M
authors: M
authors: Ota
authors: 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.
authors: M
authors: M
authors: Ohue
authors: Department of Surgery, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. Electronic address: kkomori@aichi-cc.jp.
authors: K
authors: K
authors: Komori
authors: Department of Surgery, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama 241-8515, Japan. Electronic address: shiozawam@kcch.jp.
authors: M
authors: M
authors: Shiozawa
authors: 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.
authors: T
authors: T
authors: Yamaguchi
authors: The Imperial Household Agency Hospital, 1-2, Chiyoda, Chiyoda-ku, Tokyo 100-0001, Japan. Electronic address: akasu@msf.biglobe.ne.jp.
authors: T
authors: T
authors: Akasu
authors: Department of Surgery, Miki Hospital, 100 Ushizawauwano, Kojo, Maesawa-ku, Oushu, Iwate 029-4201, Japan. Electronic address: y.y.moriya@nifty.com.
authors: Y
authors: Y
authors: Moriya
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000368:Aged; D013505:Digestive System Surgical Procedures / Q000379:methods*; D007172:Erectile Dysfunction / Q000453:epidemiology*; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods*; D008297:Male; D008643:Mesentery / Q000601:surgery*; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000453:epidemiology*; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D012007:Rectum / Q000601:surgery*; D012735:Sexual Dysfunction, Physiological / Q000453:epidemiology
keywords: Erectile dysfunction; Lymph node dissection; Randomized controlled trial; Rectal cancer; Sexual dysfunction