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

NCT ID: NCT02594241

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-11-30

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.

Conditions

Hernia, Ventral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone

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

Group Type: ACTIVE_COMPARATOR

Methyl-Prednisolone

Intervention Type: DRUG

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

Physiological saline

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

Group Type: PLACEBO_COMPARATOR

Physiological saline

Intervention Type: DRUG

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

Interventions

Methyl-Prednisolone

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

Intervention Type: DRUG

Physiological saline

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

Intervention Type: DRUG

Other Intervention Names

Solu-Medrol; Physiological Saline 9 mg/ml, Fresenius Kabi

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kristian Kiim Jensen

OTHER

Sponsor Role: lead

Responsible Party

Kristian Kiim Jensen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kristian K Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, University of Copenhagen

Locations

Bispebjerg Hospital

Copenhagen NV, Copenhagen, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27477797 (View on PubMed)

Other Identifiers

2015-806

Identifier Type: -

Identifier Source: org_study_id