PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain at rest
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Methylprednisolone
Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia.
干预措施: Methyl-Prednisolone (Drug)
Physiological saline
Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia.
干预措施: Physiological saline (Drug)
结局指标
主要结局
Pain at rest
时间窗: First postoperative day at 8 am
Self-reported pain at rest on af numerical rating scale (0-10)
次要结局
- 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)
- Fatigue(8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30)
- Nausea(8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30)
- Vomiting(From randomization until postoperative day 5)
- Time to fulfillment of discharge criteria(From randomization until postoperative day 5, assessed at 8 am and 8 pm)
- 30-postoperative complications(From randomization and until 30-days postoperatively)
- 30-day readmission(From randomization and until 30-days postoperatively)
- Rescue analgesia intake(From randomization and until day 5 postoperatively)
- C-reactive protein(From day of randomization until postoperative day 3)
研究者
Kristian Kiim Jensen
MD
Bispebjerg Hospital