- Design
- Multicentre, double-blind, placebo-controlled randomised superiority trial
- Population
- 1,210 adults having elective curative surgery for digestive cancer, 23 French centres
- Primary outcome
- Major postoperative complications within 30 days
- Effect
- 23% (139/594) methylprednisolone vs 20% (119/594) placebo; P = .16
This double-blind, placebo-controlled trial in 23 French centres randomised 1,210 patients having elective curative surgery for digestive cancer with an anastomosis to methylprednisolone 20 mg/kg at induction or placebo. The primary outcome was major complications within 30 days.
Major complications were not reduced: 23% with methylprednisolone and 20% with placebo (139 vs 119 of 594 each; P = .16). Infections overall (31% vs 30%), intra-abdominal infection (24% vs 21%), poor wound healing (15% vs 12%) and length of stay (about 13 days in both) did not differ.
The idea that blunting the inflammatory response protects the patient has been tested here properly and has not held up. A single high dose at induction should not be added to pathways for this purpose. This trial does not address the smaller antiemetic dexamethasone dose many anaesthetists already give.
- Do not add high-dose methylprednisolone at induction to reduce complications after digestive cancer surgery.
- The point estimates for complications and wound problems ran slightly against steroids, though not significantly.
- This result is about 20 mg/kg pulse dosing — it does not speak to routine low-dose antiemetic dexamethasone.
- Patients on long-term steroids still need their usual perioperative cover.
Why it matters
It closes off an anti-inflammatory strategy that had been proposed as an easy add-on to major cancer surgery.
The statistics, in plain English
With P = .16, the 3-point difference in major complications (23% vs 20%) is compatible with chance. The direction slightly favoured placebo, so the trial gives no hint of a hidden benefit that a bigger study would find.
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