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Completed

NCT Number: NCT02594241

PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial

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.

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methyl-Prednisolone

Drug

Single-shot 125 mg infusion given immediately after induction of anesthesia.

Other names: Solu-Medrol

physiological saline

Drug

A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery

Other names: Physiological Saline 9 mg/ml, Fresenius Kabi

Primary outcomes

  1. Pain at rest

    Time frame: First postoperative day at 8 am

    Self-reported pain at rest on af numerical rating scale (0-10)

Secondary outcomes

  1. Pain at rest, after moving from supine to sitting position and when coughing

    Time frame: 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)

  2. Fatigue

    Time frame: 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)

  3. Nausea

    Time frame: 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)

  4. Vomiting

    Time frame: From randomization until postoperative day 5

    Number of vomiting episodes

  5. Time to fulfillment of discharge criteria

    Time frame: From randomization until postoperative day 5, assessed at 8 am and 8 pm

    Patient's assessment of discharge criteria

  6. 30-postoperative complications

    Time frame: From randomization and until 30-days postoperatively

    Complications that require surgical or medical intervention

  7. 30-day readmission

    Time frame: From randomization and until 30-days postoperatively

    Patient readmission

  8. Rescue analgesia intake

    Time frame: From randomization and until day 5 postoperatively

    Need for intake of rescue analgesia postoperatively

  9. C-reactive protein

    Time frame: From day of randomization until postoperative day 3

    Serum C-reactive protein preoperatively and on postoperative day 1-3.

Sponsors and collaborators

Lead sponsor

Kristian Kiim Jensen

Other

Registry information

Acronym: POSAR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 3, 2015
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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