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

September 27, 2020 updated by: Kristian Kiim Jensen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Copenhagen NV, Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylprednisolone
Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia.
Drug: Methyl-Prednisolone
Single-shot 125 mg infusion given immediately after induction of anesthesia.
Other Names:
  • Solu-Medrol
Placebo Comparator: Physiological saline
Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia.
Drug: Physiological saline
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at rest
Time Frame: First postoperative day at 8 am
Self-reported pain at rest on af numerical rating scale (0-10)
First postoperative day at 8 am

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
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)
8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
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)
8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Vomiting
Time Frame: From randomization until postoperative day 5
Number of vomiting episodes
From randomization until postoperative day 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
From randomization until postoperative day 5, assessed at 8 am and 8 pm
30-postoperative complications
Time Frame: From randomization and until 30-days postoperatively
Complications that require surgical or medical intervention
From randomization and until 30-days postoperatively
30-day readmission
Time Frame: From randomization and until 30-days postoperatively
Patient readmission
From randomization and until 30-days postoperatively
Rescue analgesia intake
Time Frame: From randomization and until day 5 postoperatively
Need for intake of rescue analgesia postoperatively
From randomization and until day 5 postoperatively
C-reactive protein
Time Frame: From day of randomization until postoperative day 3
Serum C-reactive protein preoperatively and on postoperative day 1-3.
From day of randomization until postoperative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristian Kiim Jensen

Investigators

  • Principal Investigator: Kristian K Jensen, MD, Bispebjerg Hospital, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 27, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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