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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hernia, Ventral

Intervention / Treatment
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* Drug: Methyl-Prednisolone
* Drug: Physiological saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia. | Drug: Methyl-Prednisolone<br>* Single-shot 125 mg infusion given immediately after induction of anesthesia.<br>* Other names: Solu-Medrol;|
| Placebo Comparator: Physiological saline<br>Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia. | Drug: Physiological saline<br>* A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery<br>* Other names: Physiological Saline 9 mg/ml, Fresenius Kabi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest | Self-reported pain at rest on af numerical rating scale (0-10) | First postoperative day at 8 am | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest, after moving from supine to sitting position and when coughing | Self-reported pain at rest, after moving from supine to sitting position and when coughing on af numerical rating scale (0-10) | 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30 | 
| Fatigue | Self-reported fatigue on a numerical rating scale (0-10) | 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30 | 
| Nausea | Self-reported nausea on a numerical rating scale (0-10) | 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30 | 
| Vomiting | Number of vomiting episodes | From randomization until postoperative day 5 | 
| Time to fulfillment of discharge criteria | Patient's assessment of discharge criteria | From randomization until postoperative day 5, assessed at 8 am and 8 pm | 
| 30-postoperative complications | Complications that require surgical or medical intervention | From randomization and until 30-days postoperatively | 
| 30-day readmission | Patient readmission | From randomization and until 30-days postoperatively | 
| Rescue analgesia intake | Need for intake of rescue analgesia postoperatively | From randomization and until day 5 postoperatively | 
| C-reactive protein | Serum C-reactive protein preoperatively and on postoperative day 1-3. | From day of randomization until postoperative day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventral hernia, Abdominal wall reconstruction, Enhanced recovery after surgery, Steroid