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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair.
- L N Jorgensen, T Sommer, S Assaadzadeh, L Strand, A Dorfelt, M Hensler, J Rosenberg, and Danish Multicentre DANGRIP Study Group.
- Department of Surgery, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. larsnjorgensen@hotmail.com
- Br J Surg. 2013 Mar 1; 100 (4): 474-81.
BackgroundMany 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.MethodsThis 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.ResultsThe 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.ConclusionThe avoidance of suture fixation using a self-gripping mesh was not accompanied by a reduction in chronic symptoms after inguinal hernia repair.Registration NumberNCT00815698 (http://www.clinicaltrials.gov).Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
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