Clinical trial NCT02594241: PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
Official title: PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Ventral
Keywords: Ventral hernia
Abdominal wall reconstruction
Enhanced recovery after surgery
Steroid
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain at rest
timeFrame: First postoperative day at 8 am
Secondary outcomes:
measure: Pain at rest, after moving from supine to sitting position and when coughing
timeFrame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
measure: Fatigue
timeFrame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
measure: Nausea
timeFrame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
measure: Vomiting
timeFrame: From randomization until postoperative day 5
measure: Time to fulfillment of discharge criteria
timeFrame: From randomization until postoperative day 5, assessed at 8 am and 8 pm
measure: 30-postoperative complications
timeFrame: From randomization and until 30-days postoperatively
measure: 30-day readmission
timeFrame: From randomization and until 30-days postoperatively
measure: Rescue analgesia intake
timeFrame: From randomization and until day 5 postoperatively
measure: C-reactive protein
timeFrame: From day of randomization until postoperative day 3
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: Bispebjerg Hospital, University of Copenhagen
name: Kristian K Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.