Hernia, Ventral
Conditions
Brief summary
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
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.
Interventions
OTHERFast-track group
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.
Sponsors
Bispebjerg Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge | Participants will be followed for the duration of hospital stay, an expected average of 72 hours | Time from surgery to discharge \[Hours\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detailed reason for not being discharged if criteria are otherwise fulfilled | From surgery and for the duration of hospital stay, an expected average of 3 days | The reason(s) for participants not being discharged if discharge criteria are otherwise fulfilled. |
| Fatigue | Preoperative and for the duration of hospital stay, an expected average of 3 days | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No fatigue, 5 = Exhausted). |
| Pain from supine to standing | Preoperative and for the duration of hospital stay, an expected average of 3 days | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain) |
| Pain when walking 6 meters | Preoperative and for the duration of hospital stay, an expected average of 3 days | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain) |
| Nausea | Preoperative and for the duration of hospital stay, an expected average of 3 days | Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No nausea, 5 = Intolerable nausea) |
| Daily wound drain production | From surgery and for the duration of hospital stay, an expected average of 3 days | Daily registration of the fluid volume \[milliliters\] in the wound drains postoperative. |
| Vomiting episodes | Participants will be followed for the duration of hospital stay, an expected average of 3 days | The daily number of vomiting episodes will be registered for each participant |
| Continuous transcutaneous saturation | From surgery to postoperative day 3 at 12 pm | Continuous transcutaneous oxygen saturation (percentage), measured by Pulsox 300i (C) (Konica Minolta, Osaka, Japan) |
| C-reactive protein from venous blood sample | Preoperative and for the duration of hospital stay, an expected average of 3 days | Daily C-reactive protein measured in a venous blood sample. |
| Ear temperature | Preoperative and for the duration of hospital stay, an expected average of 3 days | Ear temperature (celsius degree) measured daily at 9 and 15. |
| Time to bowel function | For the duration of postoperative hospital stay, an expected average of 72 hours | The time to bowel function \[hours\] will be registered for each participant |
Countries
Denmark
Outcome results
None listed