PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be randomized to either methylprednisolone or saline preoperatively, to examine the effects of methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia repair.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kristian Kiim Jensen
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Ventral incisional hernia with horizontal fascial defect > 10 cm described at either computed tomography scan or clinical assessment

• Planned elective open hernia repair

• Ability to speak and understand Danish

• Ability to give written and oral informed consent

Exclusion Criteria:

• Daily use of systemic glucocorticoid

• New York Heart Association class 3-4 heart disease

• Chronic renal failure (eGFR < 60 ml/min per 1.73 m2)

• Insulin-dependent diabetes

• Excessive abuse of alcohol

• Known allergy to methylprednisolone or any substance in study medicine

• Planned pregnancy within three months postoperatively

• Pregnancy, evaluated by pregnancy test preoperatively

• Breastfeeding

• Actively treated ulcer disease up to one month preoperatively