Fast-track Giant Ventral Hernia Repair

Study Overview
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Brief Summary
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The implementation of an enhanced recovery pathway after giant ventral hernia repair, including preoperative high-dose steroid is examined prospectively and compared with a group of historic controls.

Detailed Description
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All patients operated on for a large incisional hernia are treated according to the study protocol. Patients are given high-dose glucocorticoid preoperative and the aim is to discharge patients at postoperative day 3. Morbidity, length of stay, pain, nausea and pulmonary function are among registered outcomes compared with a historic control group.

Official Title
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Fast-track Giant Ventral Hernia Repair

Conditions
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Hernia, Ventral

Intervention / Treatment
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* Other: Fast-track group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Horizontal fascia defect > 10 cm on computed tomography scan Planned elective open incisional hernia repair Exclusion Criteria: Known allergy against glucocorticoid treatment Insulin-treated diabetes Gastric ulcer diagnosed within four weeks preoperative Steroid-treated immune disease Planned intestinal anastomosis concomitant to hernia repair
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fast-track group<br>Patients treated according to the enhanced recovery pathway. This group is examined prospectively. | Other: Fast-track group<br>* Enhanced recovery after surgery pathway. Postoperatively, a set of well-defined discharge criteria will be assessed daily at 9:00 and 15:00, as well as pain, nausea, time to flatus, saturation and drain production.<br>|
| Control group<br>Patients treated according to the historic recovery pathway. This group is examined retrospectively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge | Time from surgery to discharge [Hours]. | Participants will be followed for the duration of hospital stay, an expected average of 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No fatigue, 5 = Exhausted). | Preoperative and for the duration of hospital stay, an expected average of 3 days | 
| Pain from supine to standing | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain) | Preoperative and for the duration of hospital stay, an expected average of 3 days | 
| Pain when walking 6 meters | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain) | Preoperative and for the duration of hospital stay, an expected average of 3 days | 
| Nausea | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No nausea, 5 = Intolerable nausea) | Preoperative and for the duration of hospital stay, an expected average of 3 days | 
| Time to bowel function | The time to bowel function [hours] will be registered for each participant | For the duration of postoperative hospital stay, an expected average of 72 hours | 
| Vomiting episodes | The daily number of vomiting episodes will be registered for each participant | Participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| Continuous transcutaneous saturation | Continuous transcutaneous oxygen saturation (percentage), measured by Pulsox 300i (C) (Konica Minolta, Osaka, Japan) | From surgery to postoperative day 3 at 12 pm | 
| C-reactive protein from venous blood sample | Daily C-reactive protein measured in a venous blood sample. | Preoperative and for the duration of hospital stay, an expected average of 3 days | 
| Ear temperature | Ear temperature (celsius degree) measured daily at 9 and 15. | Preoperative and for the duration of hospital stay, an expected average of 3 days | 
| Detailed reason for not being discharged if criteria are otherwise fulfilled | The reason(s) for participants not being discharged if discharge criteria are otherwise fulfilled. | From surgery and for the duration of hospital stay, an expected average of 3 days | 
| Daily wound drain production | Daily registration of the fluid volume [milliliters] in the wound drains postoperative. | From surgery and for the duration of hospital stay, an expected average of 3 days |