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A registry-based 2-year follow-up comparative study of two meshes used in transinguinal preperitoneal (TIPP) groin hernia repair

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Abstract

Purpose

Onflex™ mesh has replaced Polysoft™ patch on the market, without being clinically evaluated thus far in the transinguinal preperitoneal (TIPP) technique.

Methods

All consecutive TIPP registered in our registry during the overlap period of availability of both meshes were included and studied with the chronic postoperative inguinal pain (CPIP) as primary endpoint, assessed with a verbal rating scale (VRS), and included in a patient-related outcome measurement (PROM) phone questionnaire.

Results

A total of 181 Onflex cases vs 182 Polysoft cases were studied with a 2-year follow-up rate of 92% vs 88%. The overall rate of pain or discomfort was not statistically different in the 2 studied subgroups (16.5% vs 17.6%; p = 0.71), while moderate or severe pain were significantly more frequent in the Polysoft subgroup (5.5% vs 11.6%; p = 0.01). These symptoms did not interfere with the patient daily life in 16% vs 16.5% of cases, and they were self-assessed as more bothersome than the hernia in only 0.5% vs 0.5% of cases, suggesting an overestimation of the pain by the VRS. Patients assessed the result of their hernia repair as excellent or good in 97.8% vs 96.7% and medium or bad in 2.2% vs 3.3% (p = 0.53). The cumulative recurrence rate was 0% vs 2.2%. Two reoperations (one for early and one for late recurrence) were reported in the Polysoft subgroup (1%), none related to the non-absorbable memory ring.

Conclusions

These results suggest that TIPP with Onflex provides results at least similar than those with Polysoft.

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Data availability

De-identified Excel download of the database is available for double check if needed.

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Acknowledgments

The authors want to thank the Club-Hernie members and the dedicated CRA for their highly scientific behavior and involvement in the registry.

Author information

Authors and Affiliations

  1. Unité de chirurgie viscérale et digestive, Hôpital privé d’Antony, Ramsay-GDS, 1, rue Velpeau, 92160, Antony, France

    J. F. Gillion & J. M. Chollet

  2. Polyclinique St Jean, 92, avenue Dr M. Donat, 06800, Cagnes/mer, France

    M. Soler

Authors
  1. J. F. Gillion
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  2. M. Soler
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  3. J. M. Chollet
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Consortia

the Club-Hernie members

Contributions

The three authors have contributed to the present study and reviewed the present article. Operating surgeons: JMC, JFG, and MS. Study design, data management, and article writing: JFG.

Corresponding author

Correspondence to J. F. Gillion.

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Conflict of interest

The authors declare conflict of interest not directly related to the submitted work: they were given honorarium for TIPP pilot centers (JFG, JMC, MS) and expert honorarium (JFG), but no financial support from industry was provided for this article.

The Hernia-Club is an independent scientific institution whose objective is to assess the results of different techniques and medical devices for hernia repair. It therefore has relationships with many companies having an interest in independent evaluation of their products.

Ethical approval

The patients are informed that their de-identified data are registered and that they will be offered a phone questionnaire at different steps of their follow-up. Only the operating surgeon and the clinical research assistant are able to link the randomly allocated identifying number and the patient. The data are stored in a specialized Swiss data bank where they are protected against network intrusion. The registry complies with the requirements of the General Data Protection Regulation (GDPR), the French “Méthodologies de référence de la Commission Nationale Informatique et Liberté” (MR001, MR003) and the different specific French ethics committees.

Consent for publication

The three authors consent for publication of this article. Patients give their non-opposition (observational study) at the registration in an online database of their de-identified data further used for studies and scientific publications as displayed on the public frontpage of club-hernie.com.

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Gillion, J.F., Soler, M., Chollet, J.M. et al. A registry-based 2-year follow-up comparative study of two meshes used in transinguinal preperitoneal (TIPP) groin hernia repair. Langenbecks Arch Surg 406, 197–208 (2021). https://doi.org/10.1007/s00423-020-01993-x

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