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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-track group | Patients treated according to the enhanced recovery pathway. This group is examined prospectively. |
| |
| Control group | Patients treated according to the historic recovery pathway. This group is examined retrospectively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast-track group | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are scheduled to undergo elective incisional hernia repair.
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| Name | Affiliation | Role |
|---|---|---|
| Kristian K Jensen, MD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen NV | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |