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

Sponsor

Kristian Kiim Jensen (Other)

Overall Status

Completed

CT.gov ID

NCT02594241

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Ventral	Drug: Methyl-Prednisolone Drug: Physiological saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain at rest [First postoperative day at 8 am]
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 [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)
Fatigue [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)
Nausea [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)
Vomiting [From randomization until postoperative day 5]
Number of vomiting episodes
Time to fulfillment of discharge criteria [From randomization until postoperative day 5, assessed at 8 am and 8 pm]
Patient's assessment of discharge criteria
30-postoperative complications [From randomization and until 30-days postoperatively]
Complications that require surgical or medical intervention
30-day readmission [From randomization and until 30-days postoperatively]
Patient readmission
Rescue analgesia intake [From randomization and until day 5 postoperatively]
Need for intake of rescue analgesia postoperatively
C-reactive protein [From day of randomization until postoperative day 3]
Serum C-reactive protein preoperatively and on postoperative day 1-3.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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