Long-term results of the SOFTGRIP trial: TIPP versus ProGrip Lichtenstein's inguinal hernia repair.

PURPOSE: In preventing Chronic Postoperative Inguinal Pain (CPIP) after inguinal herniorrhaphy, mesh position and mesh fixation seem important factors. The SOFTGRIP trial compared the TransInguinal PrePeritoneal (TIPP) repair to Polysoft mesh, to the Open anterior repair (Lichtenstein) using the self-gripping ProGrip mesh. Since CPIP might resolve and recurrence rate increase, this study reports the SOFTGRIP trial's long-term results (with a minimal follow-up of 5 years). METHODS: All patients initially randomized in the SOFTGRIP trial were contacted if not deceased. Patients were invited for an interview and physical examination. The procedures and methodology of this randomized clinical trial have been published together with the short-term results. The main outcomes for this long-term follow-up study were chronic pain, recurrences, re-operations and numbness. RESULTS: A total of 193 patients (81.4% of the initially randomized patients) were included for long-term follow-up analyses, 96 after TIPP, 97 after ProGrip Lichtenstein. After a median follow-up of 74 months (range 60-80) there were no significant differences between the two groups. Overall, chronic pain drastically decreased. Fourteen patients reported CPIP at long-term follow-up (overall 7.3%, 7 after TIPP and 7 after ProGrip Lichtenstein, any form, frequency and intensity of pain included). Recurrence rate increased from 2.6% (n = 6) at one-year follow-up, to 8.3% (n = 16) at 5-year's follow-up. CONCLUSION: The SOFTGRIP trial´s long-term outcomes show that after both TIPP and ProGrip Lichtenstein, recurrence rate increases and CPIP mostly disappears. These findings aid in better informing patients on the benefits and harms of inguinal hernia repair. The findings of accumulating recurrences and fading of chronic pain, confirms the need for long-term follow-up studies. High-quality long-term data on TIPP, ProGrip Lichtenstein and other types of herniorrhaphy are scarce and complication rates vary widely. Further long-term studies are needed to reveal the true spectrum of benefits and harms of the different inguinal hernia repair techniques. TRIAL REGISTRATION: Registered on August 25, 2009 at the Dutch Trial Registry ( www.trialregister.nl ) NTR1853.

The transinguinal preperitoneal technique (TIPP) in inguinal hernia repair does not cause less chronic pain in relation to the ProGrip technique: a prospective double-blind randomized clinical trial comparing the TIPP technique, using the PolySoft mesh, with the ProGrip self-fixing semi-resorbable mesh.

BACKGROUND: Position of the mesh and the method of fixation are important in the occurrence of chronic pain in inguinal herniorrhaphy. An RCT was conducted to evaluate chronic pain after transinguinal preperitoneal (TIPP) repair compared with a Lichtenstein-like repair with a semi-resorbable self-fixing mesh (ProGrip). METHODS: Patients with a primary unilateral inguinal hernia were randomized either to the TIPP (PolySoft mesh) or to repair with a ProGrip mesh. Primary objective was the occurrence of chronic pain after surgery. Secondary objectives were, i.e., recurrences, complications, and quality of life. Follow-up occurred after 2 weeks, 3 months, and 1 year. Patients and physicians were blinded. RESULTS: Two hundred and fifty-eight patients were randomized to TIPP or ProGrip mesh repair. Two hundred and thirty-eight were included in the analysis: 122 in the TIPP group and 116 in the ProGrip group. Baseline characteristics were compatible. After 2 weeks and 3 months, there was significantly more moderate and severe pain in the ProGrip group on different pain scores. Median pain scores were very low in both groups after 3 months and 1 year (0-0.5 on a scale of 0-10). There was no difference in pain scores between both groups after 1 year. Recurrence rates were low; three patients in each group (2.6 % ProGrip and 2.5 % TIPP). CONCLUSION: There was no significant difference in chronic pain between the inguinal repairs with the use of a ProGrip mesh compared with a TIPP repair at 1 year after surgery. In both groups, the occurrence of chronic pain was low.