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Surgery Today
Published in: Surgery Today 6/2016

01-06-2016 | Original Article

A randomized clinical study on postoperative pain comparing the Polysoft patch to the modified Kugel patch for transinguinal preperitoneal inguinal hernia repair

Authors: Kota Okinaga, Takashi Hori, Tsuyoshi Inaba, Kazue Yamaoka

Published in: Surgery Today | Issue 6/2016

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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.
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Metadata
Title
A randomized clinical study on postoperative pain comparing the Polysoft patch to the modified Kugel patch for transinguinal preperitoneal inguinal hernia repair
Authors
Kota Okinaga
Takashi Hori
Tsuyoshi Inaba
Kazue Yamaoka
Publication date
01-06-2016
Publisher
Springer Japan
Published in
Surgery Today / Issue 6/2016
Print ISSN: 0941-1291
Electronic ISSN: 1436-2813
DOI
https://doi.org/10.1007/s00595-015-1228-x

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