TY - JOUR

T1 - Preoperative steroid in abdominal wall reconstruction

T2 - protocol for a randomised trial

AU - Jensen, Kristian Kiim

AU - Brøndum, Tina Lee

AU - Belhage, Bo

AU - Hensler, Margaret

AU - Arnesen, Regnar Bøge

AU - Kehlet, Henrik

AU - Jørgensen, Lars Nannestad

PY - 2016/8

Y1 - 2016/8

N2 - INTRODUCTION: Preoperative administration of high-dose glucocorticoid leads to improved recovery and decreased length of stay after abdominal surgery. Even so, studies on administration of glucocorticoids for patients undergoing abdominal wall reconstruction (AWR) for giant ventral hernia repair are lacking, perhaps due to a fear of impaired wound healing. We hypothesised that patients undergoing AWR would benefit from preoperative glucocorticoids and aimed at examining this in a randomised controlled trial.METHODS: A total of 40 patients scheduled to undergo AWR for ventral hernias with a fascial defect exceeding 10 cm will be randomised for intravenous administration of either 125 mg methylprednisolone or saline at the induction of anaesthesia. The primary endpoint is pain at rest on the first post-operative day. Patients will be followed until 30 days post-operatively, and secondary outcomes include subjective measures, wound complications and analysis of blood and wound fluids.CONCLUSIONS: This is the first trial on the effect of preoperative glucocorticoid administration in patients undergoing AWR. Due to long post-operative stays and a high rate of post-operative complications, this patient group can potentially benefit much from any post-operative optimisation. Furthermore, insight into any impact of glucocorticoids on wound healing in hernia patients may provide important information.FUNDING: none.TRIAL REGISTRATION: This study was registered with Clinicaltrials.gov (NCT02594241) and Eudra-CT (2015-004916-39).

AB - INTRODUCTION: Preoperative administration of high-dose glucocorticoid leads to improved recovery and decreased length of stay after abdominal surgery. Even so, studies on administration of glucocorticoids for patients undergoing abdominal wall reconstruction (AWR) for giant ventral hernia repair are lacking, perhaps due to a fear of impaired wound healing. We hypothesised that patients undergoing AWR would benefit from preoperative glucocorticoids and aimed at examining this in a randomised controlled trial.METHODS: A total of 40 patients scheduled to undergo AWR for ventral hernias with a fascial defect exceeding 10 cm will be randomised for intravenous administration of either 125 mg methylprednisolone or saline at the induction of anaesthesia. The primary endpoint is pain at rest on the first post-operative day. Patients will be followed until 30 days post-operatively, and secondary outcomes include subjective measures, wound complications and analysis of blood and wound fluids.CONCLUSIONS: This is the first trial on the effect of preoperative glucocorticoid administration in patients undergoing AWR. Due to long post-operative stays and a high rate of post-operative complications, this patient group can potentially benefit much from any post-operative optimisation. Furthermore, insight into any impact of glucocorticoids on wound healing in hernia patients may provide important information.FUNDING: none.TRIAL REGISTRATION: This study was registered with Clinicaltrials.gov (NCT02594241) and Eudra-CT (2015-004916-39).

KW - Abdominal Wall

KW - Abdominoplasty

KW - Adult

KW - Aged

KW - Dose-Response Relationship, Drug

KW - Double-Blind Method

KW - Female

KW - Follow-Up Studies

KW - Glucocorticoids

KW - Hernia, Ventral

KW - Herniorrhaphy

KW - Humans

KW - Injections, Intravenous

KW - Male

KW - Middle Aged

KW - Postoperative Complications

KW - Preoperative Care

KW - Surgical Mesh

KW - Treatment Outcome

KW - Wound Healing

KW - Journal Article

KW - Randomized Controlled Trial

M3 - Journal article

C2 - 27477797

VL - 63

JO - Danish Medical Journal

JF - Danish Medical Journal

SN - 2245-1919

IS - 8

M1 - A5260

ER -