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

Kristian Kiim Jensen

Status: Completed

Conditions: Hernia, Ventral

Treatments: Drug: Methyl-Prednisolone; Drug: Physiological saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02594241

2015-806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia.

Treatment:

Drug: Methyl-Prednisolone

Physiological saline

Placebo Comparator group

Description:

Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia.

Treatment:

Drug: Physiological saline