W J V Bökkerink1,2, M G M van Meggelen3,4, J P van Dijk3, D Čadanová5, R M H G Mollen3. 1. Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP, Ede, The Netherlands. willembokkerink@gmail.com. 2. Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands. willembokkerink@gmail.com. 3. Department of Surgery, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP, Ede, The Netherlands. 4. Currently Working at the Emergency Department, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands. 5. Department of Surgery, Amphia Hospital, Breda, The Netherlands.
Abstract
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.
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.
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