Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Feb;27(1):139-145.
doi: 10.1007/s10029-021-02542-1. Epub 2022 Jan 13.

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

W J V Bökkerink  1   2 , M G M van Meggelen  3   4 , J P van Dijk  3 , D Čadanová  5 , R M H G Mollen  3
Affiliations
Randomized Controlled Trial

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

W J V Bökkerink et al. Hernia. 2023 Feb.

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.

Keywords: Inguinal hernia; Lichtenstein—chronic postoperative inguinal pain; TIPP—self-fixing mesh.

PubMed Disclaimer

References

    1. The HerniaSurge Group (2018) International guidelines for groin hernia management. Hernia 22(1):1–165. https://doi.org/10.1007/s10029-017-1668-x - DOI
    1. van Rijckevorsel DC, de Vries M, Schreuder LT, Wilder-Smith OH, van Goor H (2015) Risk factors for chronic postsurgical abdominal and pelvic pain. Pain Manag 5(2):107–116. https://doi.org/10.2217/pmt.14.47 - DOI - PubMed
    1. Alfieri S, Amid PK, Campanelli G, Izard G, Kehlet H, Wijsmuller AR, Di Miceli D, Doglietto GB (2011) International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia 15(3):239–249. https://doi.org/10.1007/s10029-011-0798-9 - DOI - PubMed
    1. Pelissier EP, Ngo P, Gayet B (2011) Transinguinal preperitoneal patch (TIPP) under local anesthesia with sedation. Am Surg 77(12):1681–1684 - DOI - PubMed
    1. Koning GG, Keus F, Koeslag L, Cheung CL, Avci M, van Laarhoven CJ, Vriens PW (2012) Randomized clinical trial of chronic pain after the transinguinal preperitoneal technique compared with Lichtenstein’s method for inguinal hernia repair. Br J Surg 99(10):1365–1373. https://doi.org/10.1002/bjs.8862 - DOI - PubMed

Publication types

Associated data

LinkOut - more resources