Three-month results of the effect of Ultrapro or Prolene mesh on post-operative pain and well-being following endoscopic totally extraperitoneal hernia repair (TULP trial)

Abstract

Background Recurrence rates after inguinal hernia repair have been reduced to a few per cent, since mesh repair has become standard of care. Lightweight meshes reduce postoperative pain and stiffness in open anterior repair, but for endoscopic repair, the discussion about this benefit is ongoing. This study was done to analyse the effects of lightweight mesh versus heavyweight mesh following endoscopic totally extraperitoneal (TEP) hernia repair. Methods In a single-centre double-blindly randomized clinical trial, 950 patients with unilateral primary inguinal hernia were randomized to undergo endoscopic TEP using either an Ultrapro Ò or a Prolene Ò mesh. Data were collected by validated questionnaires at day 1, day 7, after 6 weeks and after 3 months, and clinical assessment was performed after 3 months. The presence of groin pain after 3 months, defined as an NRS score [3, was evaluated as the primary outcome measure. Secondary outcomes were foreign body feeling and the impact of pain and foreign body feeling on daily activities.Results At 3-month follow-up, the incidence of pain (NRS 4-10) was 2 versus 0.9 % in the lightweight and heavyweight mesh group, respectively (p = 0.17). Pain interfered with daily activities in 1.7 % of the lightweight and 1.5 % of heavyweight group. In the lightweight group, 20 % of patients reported a foreign body feeling versus 18 % in the heavyweight group (p = 0.62). No differences between the groups were observed regarding time to return to work, interference with sports and sexual activities, testicular pain and ejaculatory pain. Severe preoperative pain (OR 2.01, 95 % CI 1.21-3.35, p = 0.01) was the only independent predictor of any post-operative pain after 3 months. Conclusion Three months after TEP inguinal repair, there were no significant differences between lightweight and heavyweight mesh use regarding the incidence of pain, foreign body feeling or any other endpoint.

Efficacy and safety of a novel partially absorbable mesh in totally extraperitoneal hernia repair

“…One recent large, double-blind, randomized control trial analyzed 950 patients with unilateral primary inguinal hernias who underwent endoscopic TEP using either ULTRAPRO (partially absorbable) or Prolene (Ethicon, Somerville, NJ, USA) mesh and found no significant differences in incidence or intensity of pain, foreign body feeling, or any other end point 3 months after TEP repair. In addition, no differences were found at other time points throughout 3 months of early postoperative follow-up [ 21 24 ].…”

International guidelines for groin hernia management

“…A large 2015 study found no difference between LWM and HWM in the incidence of groin pain and foreign-body sensation. 425 A 2012 study concluded that, compared with a HWM, an LWM provided no reduction in chronic groin pain and foreign-body sensation at 3-year follow-up. 391 There were no inter-group differences in recurrence rates.…”

Methacrylic Acid Copolymer Coating Enhances Constructive Remodeling of Polypropylene Mesh by Increasing the Vascular Response

“…However, the addition of biologics or therapeutic drugs to these medical devices can be cumbersome, shorten shelf life and complicate the device's regulatory pathway. To date, synthetic alternatives have either failed to improve tissue integration (e.g., poliglecaprone) or even increased fibrosis (e.g., polyglactin coating) …”