BACKGROUND: Many patients develop discomfort after open repair of a groin hernia. It was hypothesized that suture fixation of the mesh is a cause of these symptoms. METHODS: This patient- and assessor-blinded randomized multicentre clinical trial compared a self-gripping mesh (Parietene Progrip(®)) and sutured mesh for open primary repair of uncomplicated inguinal hernia by the Lichtenstein technique. Patients were assessed before surgery, on the day of operation, and at 1 and 12 months after surgery. The primary endpoint was moderate or severe symptoms after 12 months, including a combination of chronic pain, numbness and discomfort. RESULTS: The intention-to-treat population comprised 163 patients with self-gripping mesh and 171 with sutured mesh. The 12-month prevalence of moderate or severe symptoms was 17·4 and 20·2 per cent respectively (P = 0·573). There were no significant differences between the groups in postoperative complications (33·7 versus 40·4 per cent; P = 0·215), rate of recurrent hernia within 1 year (1·2 per cent in both groups) or quality of life. CONCLUSION: The avoidance of suture fixation using a self-gripping mesh was not accompanied by a reduction in chronic symptoms after inguinal hernia repair. REGISTRATION NUMBER: NCT00815698 (http://www.clinicaltrials.gov).
RCT Entities:
BACKGROUND: Many patients develop discomfort after open repair of a groin hernia. It was hypothesized that suture fixation of the mesh is a cause of these symptoms. METHODS: This patient- and assessor-blinded randomized multicentre clinical trial compared a self-gripping mesh (Parietene Progrip(®)) and sutured mesh for open primary repair of uncomplicated inguinal hernia by the Lichtenstein technique. Patients were assessed before surgery, on the day of operation, and at 1 and 12 months after surgery. The primary endpoint was moderate or severe symptoms after 12 months, including a combination of chronic pain, numbness and discomfort. RESULTS: The intention-to-treat population comprised 163 patients with self-gripping mesh and 171 with sutured mesh. The 12-month prevalence of moderate or severe symptoms was 17·4 and 20·2 per cent respectively (P = 0·573). There were no significant differences between the groups in postoperative complications (33·7 versus 40·4 per cent; P = 0·215), rate of recurrent hernia within 1 year (1·2 per cent in both groups) or quality of life. CONCLUSION: The avoidance of suture fixation using a self-gripping mesh was not accompanied by a reduction in chronic symptoms after inguinal hernia repair. REGISTRATION NUMBER: NCT00815698 (http://www.clinicaltrials.gov).
Authors: Jose L Porrero; María J Castillo; Ana Pérez-Zapata; María T Alonso; Oscar Cano-Valderrama; Esther Quirós; Sol Villar; Beatriz Ramos; Carlos Sánchez-Cabezudo; Oscar Bonachia; Alberto Marcos; Brígido Pérez Journal: Hernia Date: 2014-11-04 Impact factor: 4.739
Authors: Merritt Denham; Brandon Johnson; Michelle Leong; Kristine Kuchta; Eliza Conaty; Michael B Ujiki; Woody Denham; Stephen P Haggerty; Zeeshan Butt; JoAnn Carbray; Matt Gitelis; John G Linn Journal: Surg Endosc Date: 2019-01-09 Impact factor: 4.584
Authors: K Andresen; J Burcharth; S Fonnes; L Hupfeld; J P Rothman; S Deigaard; D Winther; M B Errebo; R Therkildsen; D Hauge; F S Sørensen; J Bjerg; J Rosenberg Journal: Hernia Date: 2015-10-07 Impact factor: 4.739
Authors: Gernot Köhler; Michael Lechner; Franz Mayer; Ferdinand Köckerling; Rudolf Schrittwieser; René H Fortelny; Daniela Adolf; Klaus Emmanuel Journal: World J Surg Date: 2016-02 Impact factor: 3.352