Chronic pain, discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an expertise-based randomized clinical trial comparing lightweight and heavyweight mesh

M Rutegård, R Gümüsçü, G Stylianidis, P Nordin, E Nilsson, M M Haapamäki, M Rutegård, R Gümüsçü, G Stylianidis, P Nordin, E Nilsson, M M Haapamäki

Abstract

Purpose: There is a paucity of high-quality evidence concerning mesh choice in open inguinal hernia repair. Using an expertise-based randomized clinical trial design, we aimed to evaluate the postoperative impact of two different mesh types on pain and discomfort, quality of life and sex life.

Methods: In two regional hospitals, male patients with primary inguinal hernia were randomized to one of two groups of surgeons that performed the Lichtenstein operation. One group of surgeons used a heavyweight polypropylene mesh (90 g/m2, Bard™ Flatmesh, Davol) while the second group employed a lightweight mesh (28 g/m2, ULTRAPRO™, Ethicon). Follow-up data were collected by questionnaires and outpatient visits in the range of 1-3 years after surgery.

Results: Some 412 patients were randomized and 363 patients were analysed. There was no difference in pain between groups after surgery but a statistically significant difference concerning awareness of a groin lump and groin discomfort, favouring the lightweight group 1 year after surgery. No differences in quality of life between groups could be detected but both groups had a substantially better quality of life postoperatively, as compared to before surgery. In the analysis of impact on sex life, no differences between mesh groups were found.

Conclusion: The Lichtenstein operation performed for primary inguinal hernia improves quality of life for most of the male patients, independently of the type of mesh used. The lightweight mesh group experienced less awareness of a groin lump and groin discomfort 1 year postoperatively. ClinicalTrials.gov Identifier: NCT00451893.

Keywords: Groin hernia repair; Lichtenstein operation; Patient-reported outcome measures.

Conflict of interest statement

Conflict of interest

MR declares conflict of interest not directly related to the submitted work (reimbursed by Ethicon as a speaker at a colorectal symposium at the Swedish Surgical Society Meeting 2017). RG, GS, PN, EN and MM declare no conflict of interest.

Ethical approval

The study was approved by the Regional Ethical Review Board at Umeå University.

Human and animal rights

This article does not contain any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Figures

Fig. 1
Fig. 1
Consort diagram of study patients
Fig. 2
Fig. 2
Pain reported at various degrees of activity 4 months postoperatively stratified for mesh type, assessed with a standard instrument on a McCarthy visual analogue scale (0–150 mm). Boxes and whiskers indicate 25th–75th percentiles and 10th–90th percentiles, respectively. HeW heavyweight mesh group, LiW lightweight mesh group
Fig. 3
Fig. 3
Pain reported at various degrees of activity 12 months postoperatively stratified for mesh type, assessed with a standard instrument on a McCarthy visual analogue scale (0–150 mm). Boxes and whiskers indicate 25th–75th percentiles and 10th–90th percentiles, respectively. HeW heavyweight mesh group, LiW lightweight mesh group
Fig. 4
Fig. 4
EQ-5D index values preoperatively and at five postoperative time points for heavyweight and lightweight mesh groups, respectively. Preop preoperative time point immediately before surgery. Boxes and whiskers indicate 25th–75th percentiles and 10th–90th percentiles, respectively. Dark-grey figures represent the heavyweight mesh group and the corresponding light-grey boxes and whiskers represent values for the lightweight mesh. Median values are indicated by a black horizontal line for each group

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