Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair

TY - JOUR

T1 - Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair

AU - Jorgensen, L N

AU - Sommer, Thorbjørn

AU - Assaadzadeh, S

AU - Strand, L

AU - Dorfelt, A

AU - Hensler, M

AU - Rosenberg, J

AU - for the Danish Multicentre DANGRIP Study Group

N1 - Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

PY - 2013/3

Y1 - 2013/3

N2 - 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).

AB - 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).

U2 - 10.1002/bjs.9006

DO - 10.1002/bjs.9006

M3 - Journal article

C2 - 23203909

SN - 0007-1323

VL - 100

SP - 474

EP - 481

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 4

ER -