An interventional study of Methyl-Prednisolone and Physiological saline in Hernia, Ventral, sponsored by Kristian Kiim Jensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.
Sponsored by Kristian Kiim Jensen · Not applicable, Interventional, and Treatment
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 42 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Kristian Kiim Jensen is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia.
Drug: Physiological saline
Single-shot 125 mg infusion given immediately after induction of anesthesia.
Also known as: Solu-Medrol
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
Also known as: Physiological Saline 9 mg/ml, Fresenius Kabi
Pain at rest
Self-reported pain at rest on af numerical rating scale (0-10)
Time frame: First postoperative day at 8 am
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)
Time frame: 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)
Time frame: 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)
Time frame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Vomiting
Number of vomiting episodes
Time frame: From randomization until postoperative day 5
Time to fulfillment of discharge criteria
Patient's assessment of discharge criteria
Time frame: From randomization until postoperative day 5, assessed at 8 am and 8 pm
30-postoperative complications
Complications that require surgical or medical intervention
Time frame: From randomization and until 30-days postoperatively
30-day readmission
Patient readmission
Time frame: From randomization and until 30-days postoperatively
Rescue analgesia intake
Need for intake of rescue analgesia postoperatively
Time frame: From randomization and until day 5 postoperatively
C-reactive protein
Serum C-reactive protein preoperatively and on postoperative day 1-3.
Time frame: From day of randomization until postoperative day 3
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Kristian Kiim Jensen