R Bittner1, B J Leibl, B Kraft, J Schwarz. 1. Department of General and Visceral Surgery, Hernia Center, EuromedClinic Fürth, Europaallee 1, 90763 Fürth, Germany. bittnerfamilie@web.de
Abstract
BACKGROUND: A low rate of chronic pain and maximum postoperative comfort are the main goals today in inguinal hernia repair. This four-arm randomised trial compares these parameters after laparoscopic hernia repair (TAPP) with a standard heavyweight mesh (HW), a pure middleweight polypropylene mesh (MW), a lightweight composite polypropylene mesh (LW), or a titanised lightweight mesh (TLW). The primary endpoint of the study was the incidence of chronic pain of any severity at the site of hernia repair at 1 year. METHODS: A total of 600 patients with a laparoscopic inguinal hernia repair and a defect diameter of 3-5 cm were included in the trial. In all patients, a non-invasive mesh fixation technique was performed using fibrin glue. Patients were assessed for pain, foreign body sensation, and physical activities preoperatively, early postoperatively, at 4 weeks, at 6 months, and at 1 year by questionnaire, and were examined clinically. Postoperatively, seroma formation was measured by ultrasound. RESULTS: At 1 year after TAPP, frequency of pain did not differ statistically between the four groups (depending on type of activity: between 6-8% with HW mesh, 2-4% with middleweight mesh, and 2-4.7% with both lightweight meshes); average intensity of pain was very low, at between VAS 0.4 ± 3.1 and 1.5 ± 7.8 (MW, LW, TLW) and between 1.9 ± 8.6 and 2.3 ± 9.1 (HW) depending on activity (n.s.). Early postoperatively between 31.3% (LW) and 21.3% (TLW) of the patients needed pain medication (n.s.); at 1 year this percentage had dropped to 0.3% (one HW, one MW). Foreign body sensation did not differ but impairment of physical activities (P = 0.0437) was significantly less in the MW, LW, and TLW group (6-12.7%) compared to HW (15.3%) at 4 weeks; at 1 year this percentage was between 0 and 1.3% (n.s.). CONCLUSION: Compared to HW mesh, the use of MW, LW, and TLW meshes for laparoscopic hernia repair did not significantly affect rate of chronic pain, but seemed to improve early postoperative convalescence. No difference was found between middleweight pure polypropylene (MW), composite lightweight (LW), or titanised lightweight polypropylene (TLW) meshes.
RCT Entities:
BACKGROUND: A low rate of chronic pain and maximum postoperative comfort are the main goals today in inguinal hernia repair. This four-arm randomised trial compares these parameters after laparoscopic hernia repair (TAPP) with a standard heavyweight mesh (HW), a pure middleweight polypropylene mesh (MW), a lightweight composite polypropylene mesh (LW), or a titanised lightweight mesh (TLW). The primary endpoint of the study was the incidence of chronic pain of any severity at the site of hernia repair at 1 year. METHODS: A total of 600 patients with a laparoscopic inguinal hernia repair and a defect diameter of 3-5 cm were included in the trial. In all patients, a non-invasive mesh fixation technique was performed using fibrin glue. Patients were assessed for pain, foreign body sensation, and physical activities preoperatively, early postoperatively, at 4 weeks, at 6 months, and at 1 year by questionnaire, and were examined clinically. Postoperatively, seroma formation was measured by ultrasound. RESULTS: At 1 year after TAPP, frequency of pain did not differ statistically between the four groups (depending on type of activity: between 6-8% with HW mesh, 2-4% with middleweight mesh, and 2-4.7% with both lightweight meshes); average intensity of pain was very low, at between VAS 0.4 ± 3.1 and 1.5 ± 7.8 (MW, LW, TLW) and between 1.9 ± 8.6 and 2.3 ± 9.1 (HW) depending on activity (n.s.). Early postoperatively between 31.3% (LW) and 21.3% (TLW) of the patients needed pain medication (n.s.); at 1 year this percentage had dropped to 0.3% (one HW, one MW). Foreign body sensation did not differ but impairment of physical activities (P = 0.0437) was significantly less in the MW, LW, and TLW group (6-12.7%) compared to HW (15.3%) at 4 weeks; at 1 year this percentage was between 0 and 1.3% (n.s.). CONCLUSION: Compared to HW mesh, the use of MW, LW, and TLW meshes for laparoscopic hernia repair did not significantly affect rate of chronic pain, but seemed to improve early postoperative convalescence. No difference was found between middleweight pure polypropylene (MW), composite lightweight (LW), or titanised lightweight polypropylene (TLW) meshes.
Authors: M P Simons; T Aufenacker; M Bay-Nielsen; J L Bouillot; G Campanelli; J Conze; D de Lange; R Fortelny; T Heikkinen; A Kingsnorth; J Kukleta; S Morales-Conde; P Nordin; V Schumpelick; S Smedberg; M Smietanski; G Weber; M Miserez Journal: Hernia Date: 2009-07-28 Impact factor: 4.739
Authors: M M Poelman; B van den Heuvel; J D Deelder; G S A Abis; N Beudeker; R R Bittner; G Campanelli; D van Dam; B J Dwars; H H Eker; A Fingerhut; I Khatkov; F Koeckerling; J F Kukleta; M Miserez; A Montgomery; R M Munoz Brands; S Morales Conde; F E Muysoms; M Soltes; W Tromp; Y Yavuz; H J Bonjer Journal: Surg Endosc Date: 2013-05-25 Impact factor: 4.584