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

Hernia, Ventral Clinical Trial

— POSAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594241
• Other study ID #: 2015-806
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2020
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

Drug:
• Methyl-Prednisolone
Single-shot 125 mg infusion given immediately after induction of anesthesia.
• Physiological saline
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Kristian Kiim Jensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at rest	Self-reported pain at rest on af numerical rating scale (0-10)	First postoperative day at 8 am
Secondary	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)	8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Secondary	Fatigue	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
Secondary	Nausea	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
Secondary	Vomiting	Number of vomiting episodes	From randomization until postoperative day 5
Secondary	Time to fulfillment of discharge criteria	Patient's assessment of discharge criteria	From randomization until postoperative day 5, assessed at 8 am and 8 pm
Secondary	30-postoperative complications	Complications that require surgical or medical intervention	From randomization and until 30-days postoperatively
Secondary	30-day readmission	Patient readmission	From randomization and until 30-days postoperatively
Secondary	Rescue analgesia intake	Need for intake of rescue analgesia postoperatively	From randomization and until day 5 postoperatively
Secondary	C-reactive protein	Serum C-reactive protein preoperatively and on postoperative day 1-3.	From day of randomization until postoperative day 3