Glucocorticoid therapy is prescribed for a variety of inflammatory conditions and is associated with severe adverse effects. A glucocorticoid withdrawal syndrome (GWS) may occur after prolonged glucocorticoid treatment—with or without biochemical glucocorticoid-induced adrenal insufficiency (GIAI). Previously, GWS was not considered an entity, probably due to the overlap between symptoms of GWS and GIAI. The Addison’s disease-specific quality of life questionnaire (AddiQoL-30) is a validated tool for quantifying symptoms of adrenal insufficiency resembling GWS. In the present study, we test the hypothesis that patients with a low AddiQoL-30 score and/or low cortisol response to a short Synacthen test (SST), after cessation of prednisolone treatment, may benefit from low-dose hydrocortisone therapy without increasing the risk of metabolic and cardiovascular disease during prolonged cortisol exposure.

REPLACE is a multi-centre, double-blinded, placebo-controlled randomised controlled trial in patients with polymyalgia rheumatica or giant cell arteritis after cessation of prednisolone treatment. Criteria for randomisation are an AddiQoL-30 score ≤85 and/or plasma cortisol response to SST, 30-min p-cortisol >100 and 85; and (2) patients with a SST-stimulated cortisol ≤100 nmol/L.

The study is conducted in accordance with the Declaration of Helsinki, registered at the Clinical Trials Information System (CTIS: 2024-513822-53-00) and Clinicaltrials.gov (NCT05193396), and publications will be in accordance with the recommendations of the International Committee of Medical Journal Editors. The trial is monitored by local independent Good Clinical Practice units and overseen by the Danish Data Protection Agency (journal no. 21/27119), the Regional Committees on Health Research Ethics for Southern Denmark (project ID: S-20210076), the Danish Patient Safety Authority and the Danish Medicines Agency.

NCT05193396.

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.

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.

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.

The RECOVER study has been registered at clinicaltrials.gov (NCT06449378).