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The HIPPO Trial, a Randomized Double-blind Trial Comparing Self-gripping Parietex Progrip Mesh and Sutured Parietex
Marijke J Molegraaf1, Brechtje Grotenhuis, Bart Torensma
1*Department of General Surgery, Groene Hart Hospital, Gouda, The Netherlands †Department of General Surgery, Erasmus Medical Center, Rotterdam, The Netherlands ‡Department of General Surgery, Sint Franciscus Gasthuis, Rotterdam, The Netherlands §Department of General Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Objective:
To evaluate the effect of a self-gripping mesh (Progrip) on the incidence of chronic postoperative inguinal pain (CPIP) and recurrence rate after Lichtenstein hernioplasty.
Background:
Chronic pain is the most common complication of inguinal hernioplasty. One of the causes may be the use of sutures to secure the mesh.
Methods:
Adult male patients undergoing Lichtenstein hernioplasty for a primary unilateral inguinal hernia were randomized to a self-gripping polyester mesh or a sutured polyester mesh. Follow-up took place after 2 weeks, 3, 12, and 24 months. Pain and quality of life were assessed using the Verbal Rating Scale, Visual Analog Scale, and Short Form 36. CPIP was defined as moderate pain lasting at least 3 months postoperatively.
Results:
There were 165 patients in the Progrip mesh group and 166 patients in the sutured mesh group. The incidence of CPIP was 7.3% at 3 months declining to 4.6% at 24 months and did not differ between both groups. Pain and quality of life scores were significantly improved after 2 years. Hernia recurrence rate after 24 months was 2.4% for the Progrip mesh and 1.8% for the sutured mesh (P = 0.213). The mean duration of surgery was significant shorter with the Progrip mesh (44 vs 53 minutes, P < 0.001).
Conclusions:
The self-gripping Progrip mesh does not reduce CPIP rates. Outcomes of the Progrip mesh are comparable to the Lichtenstein technique with the additional advantage of a reduced operation time. NCT01830452.
