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Feasibility and outcomes of Desarda vs Lichtenstein hernioplasty by local anesthesia for inguinal hernia: a noninferiority randomized clinical trial

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Abstract

Introduction

The Desarda autologous tissue repair is comparable to the Lichtenstein hernioplasty for inguinal hernia regarding recurrence, chronic groin pain, and return to work activities. This study was designed to establish the outcomes of Desarda's repair versus Lichtenstein's hernioplasty concerning post-operative recovery to normal gait and its feasibility under local anesthesia (LA).

Materials and methods

This study was a single-center, prospective, double-blinded, non-inferiority, randomized trial. Patients undergoing open hernia repair for primary inguinal hernia were included. Patients were randomly assigned and followed up for 2 years. The primary endpoint was the time to return to normal gait post-surgery with comfort (non-inferiority margin fixed as 0.5 days). The secondary outcomes studied were post-operative pain score, the time required to return to work (all previously performed activities), and surgical-site occurrences (SSO).

Results

One hundred ten eligible patients were randomly assigned [56 patients (50.9%) in the Desarda group and 54 patients (49.1%) in the Lichtenstein group]. All the procedures were safely performed under LA. The median (interquartile range) time for resuming gait post-surgery with comfort was 5 days in the Desarda vs 4 days in Lichtenstein's arm (P = 0.16), thereby failing to demonstrate non-inferiority of Desarda against Lichtenstein hernioplasty. However, there were no significant differences in days to return to work, SSO, chronic groin pain, and recurrence within two years of surgery.

Conclusions and relevance

This study could not demonstrate the non-inferiority of the Desarda repair versus Lichtenstein hernioplasty regarding the time taken to return to normal gait. Comparing the days to return to work, pain score, SSO, and chronic groin pain, including recurrence rate, Desarda repair faired equally with Lichtenstein hernioplasty, thereby highlighting its feasibility and efficacy under LA.

Trial registration

ClinicalTrials.gov Identifier: NCT03512366.

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Data availability

The datasheet of the study can be obtained from the corresponding author on reasonable request.

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Acknowledgements

The authors would like to acknowledge the contribution of the faculty from the Department of Surgery who made this RCT possible.

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Authors and Affiliations

  1. Department of General Surgery, All India Institute of Medical Sciences, Sijua, Bhubaneswar, 751019, India

    P. K. Sasmal, A. Sahoo, T. S. Mishra, K. K. Das Poddar, S. M. Ali, P. K. Singh & P. Kumar

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  1. P. K. Sasmal
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  2. A. Sahoo
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  3. T. S. Mishra
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Contributions

All the authors contributed substantially to the conception, design, acquisition of data, analysis, and interpretation of data in this study. All the authors participated in the drafting of the article, revising it critically for important intellectual content. Authors give final approval of the version to be published. All the authors gave final approval of the version to be published.

Corresponding author

Correspondence to P. K. Sasmal.

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Conflict of interest

Dr Prakash Kumar Sasmal, Dr Ankit Sahoo, Dr Tushar S Mishra, Dr Kallol Kumar Das Poddar, Dr S Manwar Ali, Dr Pradeep Kumar Singh and Dr Pankaj Kumar state that they do not have any financial ties or any conflicts of interest to disclose.

Ethical approval, Human and animal rights, and Informed consent

This study was conducted according to the Declaration of Helsinki and the ethical guidelines for medical research involving human subjects in India. Written informed consent was obtained from all participants. Ethical approval for this study was obtained from the Institutional Ethics Committee (IEC).

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Sasmal, P.K., Sahoo, A., Mishra, T.S. et al. Feasibility and outcomes of Desarda vs Lichtenstein hernioplasty by local anesthesia for inguinal hernia: a noninferiority randomized clinical trial. Hernia 27, 1155–1163 (2023). https://doi.org/10.1007/s10029-023-02837-5

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