Kota Okinaga1,2, Takashi Hori3, Tsuyoshi Inaba4, Kazue Yamaoka5. 1. Okinaga Clinic, Shimizu-cho 1-10, Itabashi-ku, Tokyo, 174-0053, Japan. kota@khe.biglobe.ne.jp. 2. Shin-Itabashi Clinic, Itabashi 4-4-4, Itabashi-ku, Tokyo, 173-0004, Japan. kota@khe.biglobe.ne.jp. 3. Department of Surgery, Terada Hospital, Ohgi 1-20-12, Adachi-ku, Tokyo, 123-0873, Japan. 4. Department of Surgery, Teikyo University Hospital, Kaga 2-11-1, Itabashi-ku, Tokyo, 173-8605, Japan. 5. Teikyo University Graduate School of Public Health, Kaga 2-11-1, Itabashi-ku, Tokyo, 173-8605, Japan.
Abstract
PURPOSE: The transinguinal preperitoneal approach is a relatively new technique for inguinal hernia repair. Two types of memory-ring mesh are available in Japan: the modified Kugel patch (MK) and the Polysoft patch (PP). We tested the hypothesis that the PP is noninferior to the MK with respect to chronic postoperative pain. METHODS: An unblinded randomized controlled trial was conducted to assess the noninferiority of PP compared to MK with a 5 % noninferiority margin. A total of 442 inguinal hernia patients operated on from November 2010 to December 2012 were included in this study. The primary endpoint was the pain score assessed by the visual analog scale (VAS) (0-1 vs. 2-10) 1 year after surgery. RESULTS: The patients were randomized to the PP and MK groups (n = 221 each). One year after surgery, 206 patients (95.4 %) in the PP group and 182 patients (89.6 %) in the MK group rated pain at 0-1 on the VAS scale. According to this rating, the PP group appeared not to be inferior to the MK group (95 % confidence interval, 0.7-10.7 %, P < 0.05). Furthermore, crude superiority tests, adjusting for 1 month of pain, denoted that the outcomes were significantly improved with the PP compared to the MK. CONCLUSIONS: The use of the PP was noninferior to the MK with respect to the severity of postoperative chronic pain scores 12 months after surgery.
RCT Entities:
PURPOSE: The transinguinal preperitoneal approach is a relatively new technique for inguinal hernia repair. Two types of memory-ring mesh are available in Japan: the modified Kugel patch (MK) and the Polysoft patch (PP). We tested the hypothesis that the PP is noninferior to the MK with respect to chronic postoperative pain. METHODS: An unblinded randomized controlled trial was conducted to assess the noninferiority of PP compared to MK with a 5 % noninferiority margin. A total of 442 inguinal herniapatients operated on from November 2010 to December 2012 were included in this study. The primary endpoint was the pain score assessed by the visual analog scale (VAS) (0-1 vs. 2-10) 1 year after surgery. RESULTS: The patients were randomized to the PP and MK groups (n = 221 each). One year after surgery, 206 patients (95.4 %) in the PP group and 182 patients (89.6 %) in the MK group rated pain at 0-1 on the VAS scale. According to this rating, the PP group appeared not to be inferior to the MK group (95 % confidence interval, 0.7-10.7 %, P < 0.05). Furthermore, crude superiority tests, adjusting for 1 month of pain, denoted that the outcomes were significantly improved with the PP compared to the MK. CONCLUSIONS: The use of the PP was noninferior to the MK with respect to the severity of postoperative chronic pain scores 12 months after surgery.
Authors: A Yazdankhah Kenary; S N Afshin; H Ahmadi Amoli; A Yagoobi Notash; A Borjian; A Yagoobi Notash; S Shafaattalab; G Shafiee Journal: Hernia Date: 2012-11-09 Impact factor: 4.739
Authors: Willem J V Bökkerink; Giel G Koning; Patrick W H E Vriens; Roland M H G Mollen; Mitchell J R Harker; Robin K Noordhof; Willem L Akkersdijk; Cees J H M van Laarhoven Journal: Ann Surg Date: 2021-11-01 Impact factor: 13.787