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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia. |
|
| Physiological saline | Placebo Comparator | Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl-Prednisolone | Drug | Single-shot 125 mg infusion given immediately after induction of anesthesia. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian K Jensen, MD | Bispebjerg Hospital, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen NV | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27477797 | Derived | Jensen KK, Brondum TL, Belhage B, Hensler M, Arnesen RB, Kehlet H, Jorgensen LN. Preoperative steroid in abdominal wall reconstruction: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5260. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Physiological saline | Drug | A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery |
|
|
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 |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |