Preoperative steroid before operation for giant incisional hernia

Phase 1

Conditions: Patients who undergo abdominal wall reconstruction for repair of a giant ventral hernia
MedDRA version: 19.0Level: HLTClassification code 10021620Term: Incisional herniasSystem Organ Class: 100000004856
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-004916-39-DK

Lead Sponsor: Digestive Disease Center, Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the effects of methylprednisolone on postoperative pain after giant ventral hernia repair.;Secondary Objective: To examine the effects of methylprednisolone on postoperative nausea and recovery after giant ventral hernia repair.;Primary end point(s): Self-reported pain at rest on af numerical rating scale (0-10);Timepoint(s) of evaluation of this end point: First postoperative day at 8 am<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain at rest<br>Fatigue<br>Nausea<br>Vomiting<br>Rescue analgesia intake<br>Time to discharge<br>30-day complications<br>;Timepoint(s) of evaluation of this end point: The first five postoperative days at 8 am and 8 pm.<br>Complications occuring within first 30 days postoperatively