Hernia, Ventral
Conditions
Keywords
Ventral hernia, Abdominal wall reconstruction, Enhanced recovery after surgery, Steroid
Brief 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.
Interventions
Single-shot 125 mg infusion given immediately after induction of anesthesia.
DRUGPhysiological saline
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
Sponsors
Kristian Kiim Jensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest | First postoperative day at 8 am | Self-reported pain at rest on af numerical rating scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30 | Self-reported fatigue on a numerical rating scale (0-10) |
| Nausea | 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30 | Self-reported nausea on a numerical rating scale (0-10) |
| Vomiting | From randomization until postoperative day 5 | Number of vomiting episodes |
| Time to fulfillment of discharge criteria | From randomization until postoperative day 5, assessed at 8 am and 8 pm | Patient's assessment of discharge criteria |
| Pain at rest, after moving from supine to sitting position and when coughing | 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30 | Self-reported pain at rest, after moving from supine to sitting position and when coughing on af numerical rating scale (0-10) |
| 30-day readmission | From randomization and until 30-days postoperatively | Patient readmission |
| Rescue analgesia intake | From randomization and until day 5 postoperatively | Need for intake of rescue analgesia postoperatively |
| C-reactive protein | From day of randomization until postoperative day 3 | Serum C-reactive protein preoperatively and on postoperative day 1-3. |
| 30-postoperative complications | From randomization and until 30-days postoperatively | Complications that require surgical or medical intervention |
Countries
Denmark
Outcome results
None listed