NCT02594241

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Kristian Kiim Jensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Preoperative high-dose glucocorticoid has been shown to attenuate the postoperative inflammatory response leading to decreased morbidity and length of stay (LOS) after colorectal and aortic surgery, as well as decreased pain and subjective recovery after orthopedic surgery. Methylprednisolone (MP, "Solu-Medrol") is one such glucocorticoid, which has been shown to be safe for usage in surgery. Giant ventral hernia repair is associated with a high risk of postoperative morbidity and prolonged LOS compared with other hernia repair procedures requiring laparotomy. Further, the total costs of these procedures remain high. Systemic administration of high-dose preoperative MP in ventral hernia repair has only been described anecdotally in the literature, and never with the aim to improve the treatment of this patient group specifically. It is however unknown to what extent benefits weigh out downsides from usage of high-dose MP in giant ventral hernia repair, patients often at increased risk of postoperative wound infection. On this background we hypothesize that a preoperative high-dose MP results in improved recovery after giant ventral hernia repair compared with placebo.

Conditions

• Hernia, Ventral

Interventions

Type	Name	Description
DRUG	Methyl-Prednisolone	Single-shot 125 mg infusion given immediately after induction of anesthesia.
DRUG	Physiological saline	A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-05-01
• Completion: 2018-11-01
• First posted: 2015-11-03
• Last updated: 2020-09-29

Locations

1 site across 1 country: Denmark