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Randomized clinical trial comparing self‐gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. BJS 2014; 101: 1373-1382.

Published: 21st August 2014

Authors: D. L. Sanders, S. Nienhuijs, P. Ziprin, M. Miserez, M. Gingell‐Littlejohn, S. Smeds et al.

Background

Postoperative pain is an important adverse event following inguinal hernia repair. The aim of this trial was to compare postoperative pain within the first 3 months and 1 year after surgery in patients undergoing open mesh inguinal hernia repair using either a self‐gripping lightweight polyester mesh or a polypropylene lightweight mesh fixed with sutures.

Method

Adult men undergoing Lichtenstein repair for primary inguinal hernia were randomized to ProGrip™ self‐gripping mesh or standard sutured lightweight polypropylene mesh.

Results

In total 557 men were included in the final analysis (self‐gripping mesh 270, sutured mesh 287). Early postoperative pain scores were lower with self‐gripping mesh than with sutured lightweight mesh: mean visual analogue pain score relative to baseline +1·3 and +8·6 respectively at discharge (P = 0·033), and mean surgical pain scale score relative to baseline +4·2 and +9·7 respectively on day 7 (P = 0·027). There was no significant difference in mid‐term (1 month) and long‐term (3 months and 1 year) pain scores between the groups. Surgery was significantly quicker with self‐gripping mesh (mean difference 7·6 min; P < 0·001). There were no significant differences in reported mesh handling, analgesic consumption, other wound complications, patient satisfaction or hernia recurrence between the groups.

Conclusion

Self‐gripping mesh for open inguinal hernia repair was well tolerated and reduced early postoperative pain (within the first week), without increasing the risk of early recurrence. It did not reduce chronic pain. Registration number: NCT00827944 (http://www.clinicaltrials.gov).

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4 Comments

Kirsty McFarlane

3 years ago

Dear Sir

I congratulate Sanders et al. for publishing the largest randomized controlled trial reporting the efficacy of self-gripping mesh in open inguinal hernia repair (1). This article is well written with sound methodology. However, I would like to draw their attention towards a meta-analysis we published of four randomized controlled trials encompassing 1115 patients published on same technique (2). This reported that self-gripping mesh in open inguinal hernia repair failed to demonstrate any superiority over suture mesh-fixation technique in terms of postoperative groin pain. In addition, hernia recurrence, postoperative complications and length of stay was also unchanged, except it was associated with overall shorter operative time. This article reported stronger evidence on the same subject and for some reason it was not cited at all.

MS Sajid

Western Sussex Hospitals NHS Trust, Worthing Hospital
Lyndhurst Road
Worthing BN11 2DH
UK
surgeon1wrh@hotmail.com

References:
1. Sanders DL, Nienhuijs S, Ziprin P, Miserez M, M. Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg 2014; 101: 1373–1382.
2. Sajid MS, Farag S, Singh KK, Miles WF. Systematic review and meta-analysis of published randomized controlled trials comparing the role of self-gripping mesh against suture mesh fixation in patients undergoing open inguinal hernia repair. Updates Surg 2014; 66: 189–196.

Kirsty McFarlane

3 years ago

Dear Sir,

We read this article with great interest and congratulate the authors for their work. This is an important multicentre randomised study and it will add valuable data for future hernia practice. We accept the fact that self adhering mesh may decrease the operative time as the time to suture the mesh will be excluded. In our experience, handling of this mesh is difficult in the first few cases and this generally improves after initial learning curve. It is interesting to know that the resection of ilio-hypogastric nerve resulted in reduced postoperative pain. There are some questions, which need to be addressed.
As the inclusion criteria included age 30–75; can the authors please explain the reason to exclude the patients age 70 as described in CONSORT diagram? I addition in most situations visual analogue score (VAS) scale 0–10 cm (0–100 mm) is used (1,2). In this study, however, a VAS scale 0–150 mm was used. What was the reason for this?. Would the difference in pain after surgery on a scale of 0–100mm have been significant or not?
Early postoperative pain may be influenced by perioperative analgesia and local/regional anaesthetic infiltration. Was there a standard protocol about the dose, type, time of administration of these drugs?

Sana Ullah
Tarek Katbeh
Lindsey Chisholm
Susan Moug
Andrew Renwick

Department of surgery
Royal Alexandra Hospital
Paisley PA2 9PN
UK
drsanavri@hotmail.com

References:
1. Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health 1990; 13: 227-236.
2. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken); 63 Suppl 11: S240-S252.

Kirsty McFarlane

3 years ago

We thank Mr Sajid for his comments about the randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair (1). The meta-analysis he refers to (2) was not included in the discussion because it had not been published at the time of submission.

DL Sanders
Department of Surgery
Derriford Hospital
Plymouth PL6 8DH
UK
dsanders@doctors.org.uk

References:
1. Sanders DL, Nienhuijs S, Ziprin P, Miserez M, M. Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg 2014; 101: 1373–1382.
2. Sajid MS, Farag S, Singh KK, Miles WF. Systematic review and meta-analysis of published randomized controlled trials comparing the role of self-gripping mesh against suture mesh fixation in patients undergoing open inguinal hernia repair. Updates Surg 2014; 66: 189–196.

Kirsty McFarlane

3 years ago

Dear Sir,

We thank the authors for their constructive comments. They correctly point out an error in the CONSORT diagram, which should read >75 years instead of >70 years. They also correctly identify that most studies assessing postoperative pain after inguinal hernia repair use a visual analogue scale (VAS) of 0-100mm. The 0-150mm VAS was used after consultation with a post herniorrhaphy pain expert. Their recommendation was the 0-150mm scale, in the belief that it provides a more detailed tool. We acknowledge that there is no objective evidence to substantiate this claim and it makes comparison with other trials more difficult. It is not possible to know whether the results using a 0-100mm scale would have been significant but one can presume given the linear nature of the scales that the results would have been similar.

There was a standardised protocol for local anaesthetic use and perioperative pain management, however some variation was allowed, in keeping with local policies in a multi-centre trial. All patients who had general anaesthesia received local wound infiltration with either 0.5% Bupivacaine, 0.5% Levobupivicaine or 0.5% Chirocaine. Infiltration with 20mls of local anaesthetic was recommended unless this was greater than the recommended allowance by patient weight (in which case the amount was reduced accordingly). All patients received postoperative Paracetamol and non-steroidal inflammatory (NSAID). For patients who were intolerant of NSAIDs, codeine phosphate was prescribed. We appreciate that the variability in local anaesthetic and postoperative analgesia had the potential to influence the results. For this reason multivariate analysis was performed, this revealed no significant effect of local anaesthetic and postoperative analgesia variation in the current study.

DL Sanders
Department of Surgery
Derriford Hospital
Plymouth PL6 8DH
UK
dsanders@doctors.org.uk