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

Primary Purpose

Hernia, Ventral

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Methyl-Prednisolone
Physiological saline
Sponsored by
Kristian Kiim Jensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring Ventral hernia, Abdominal wall reconstruction, Enhanced recovery after surgery, Steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisolone

Physiological saline

Arm Description

Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia.

Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain at rest, after moving from supine to sitting position and when coughing
Self-reported pain at rest, after moving from supine to sitting position and when coughing on af numerical rating scale (0-10)
Fatigue
Self-reported fatigue on a numerical rating scale (0-10)
Nausea
Self-reported nausea on a numerical rating scale (0-10)
Vomiting
Number of vomiting episodes
Time to fulfillment of discharge criteria
Patient's assessment of discharge criteria
30-postoperative complications
Complications that require surgical or medical intervention
30-day readmission
Patient readmission
Rescue analgesia intake
Need for intake of rescue analgesia postoperatively
C-reactive protein
Serum C-reactive protein preoperatively and on postoperative day 1-3.

Full Information

First Posted
October 29, 2015
Last Updated
September 27, 2020
Sponsor
Kristian Kiim Jensen
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1. Study Identification

Unique Protocol Identification Number
NCT02594241
Brief Title
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
Acronym
POSAR
Official Title
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristian Kiim Jensen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
Keywords
Ventral hernia, Abdominal wall reconstruction, Enhanced recovery after surgery, Steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia.
Arm Title
Physiological saline
Arm Type
Placebo Comparator
Arm Description
Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Methyl-Prednisolone
Other Intervention Name(s)
Solu-Medrol
Intervention Description
Single-shot 125 mg infusion given immediately after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Physiological saline
Other Intervention Name(s)
Physiological Saline 9 mg/ml, Fresenius Kabi
Intervention Description
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
Primary Outcome Measure Information:
Title
Pain at rest
Description
Self-reported pain at rest on af numerical rating scale (0-10)
Time Frame
First postoperative day at 8 am
Secondary Outcome Measure Information:
Title
Pain at rest, after moving from supine to sitting position and when coughing
Description
Self-reported pain at rest, after moving from supine to sitting position and when coughing on af numerical rating scale (0-10)
Time Frame
8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Title
Fatigue
Description
Self-reported fatigue on a numerical rating scale (0-10)
Time Frame
8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Title
Nausea
Description
Self-reported nausea on a numerical rating scale (0-10)
Time Frame
8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Title
Vomiting
Description
Number of vomiting episodes
Time Frame
From randomization until postoperative day 5
Title
Time to fulfillment of discharge criteria
Description
Patient's assessment of discharge criteria
Time Frame
From randomization until postoperative day 5, assessed at 8 am and 8 pm
Title
30-postoperative complications
Description
Complications that require surgical or medical intervention
Time Frame
From randomization and until 30-days postoperatively
Title
30-day readmission
Description
Patient readmission
Time Frame
From randomization and until 30-days postoperatively
Title
Rescue analgesia intake
Description
Need for intake of rescue analgesia postoperatively
Time Frame
From randomization and until day 5 postoperatively
Title
C-reactive protein
Description
Serum C-reactive protein preoperatively and on postoperative day 1-3.
Time Frame
From day of randomization until postoperative day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian K Jensen, MD
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen NV
State/Province
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27477797
Citation
Jensen KK, Brondum TL, Belhage B, Hensler M, Arnesen RB, Kehlet H, Jorgensen LN. Preoperative steroid in abdominal wall reconstruction: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5260.
Results Reference
derived

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

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