New synthetic resorbable mesh for open ventral hernia repair: the multicentre, single-arm, prospective study of Transorb self-gripping resorbable mesh in subjects undergoing open repair of ventral hernia in clean and clean-contaminated fields (RECOVER) protocol

Abstract

Introduction: Ventral hernia repair is among the most commonly performed general surgical procedures, during which meshes are often used to provide further support to weakened or damaged tissue surrounding the hernia repair site. Slowly resorbable synthetic meshes have recently emerged as a valid choice, as confirmed by published clinical evidence on launched meshes in the repair of ventral hernias showing satisfactory results. This study was designed to assess the performance and safety of a newly developed slowly fully resorbable self-gripping synthetic mesh in patients undergoing ventral hernia repair through open surgery in clean and clean-contaminated fields.

Methods and analysis: This is a prospective, multicentre, single-arm study that will be conducted in up to 20 European and US sites with a total of 163 patients undergoing midline primary or incisional ventral hernia repair in clean or clean-contaminated surgical fields using an open surgical approach and implanted with Transorb self-gripping resorbable mesh in retrorectus placement with or without transversus abdominis release. The study will include patients ≥18 years old, presenting at least one risk factor impairing wound healing. The primary endpoint will be hernia recurrence rate within 12 months, postoperatively evaluated by physical exam; secondary endpoints will include hernia recurrence rate within 1 month, 6 months, 24 months, 36 months, 48 months and 60 months postoperatively, hernia recurrence rate resulting in reoperation, hernia recurrence rate reported by patients, time to hernia recurrence, rate of surgical site occurrence (SSO), rate of SSO requiring procedural interventions, surgeon satisfaction and change in patient-reported pain and quality of life. The study will be considered successful if the upper limit of the 95% Bayesian credible interval for the primary endpoint is less than 14.2%. Descriptive statistics will be used to summarise secondary study endpoints unless otherwise noted.

Ethics and dissemination: The multicentre, single-arm, prospective study of Transorb self-gripping resorbable mesh in subjects undergoing open repair of ventral hernia study will be conducted in compliance with the Good Clinical Practice standards, ISO 14155:2020 and the Declaration of Helsinki. The publication plan includes dissemination of the 12-month, 24-month, 36-month, 48-month and 60 month study results.

Trial registration number: The RECOVER study has been registered at clinicaltrials.gov (NCT06449378).

Keywords: Adult surgery; Clinical Protocols; Clinical Trial; SURGERY.