NCT02594241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

October 29, 2015

Last Update Submit

September 27, 2020

Conditions

Hernia, Ventral

Keywords

Ventral herniaAbdominal wall reconstructionEnhanced recovery after surgerySteroid

Outcome Measures

Primary Outcomes (1)

  • Pain at rest

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

    First postoperative day at 8 am

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

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

Physiological saline

PLACEBO COMPARATOR

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

Drug: Physiological saline

Interventions

Methyl-PrednisoloneDRUG

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

Also known as: Solu-Medrol
Methylprednisolone
Physiological salineDRUG

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

Also known as: Physiological Saline 9 mg/ml, Fresenius Kabi
Physiological saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 27477797DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kristian K Jensen, MD

    Bispebjerg Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

DK(1)