Fast-track Giant Ventral Hernia Repair
- Conditions
- Hernia, Ventral
- Interventions
- Other: Fast-track group
- Registration Number
- NCT02305082
- Lead Sponsor
- Bispebjerg Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Horizontal fascia defect > 10 cm on computed tomography scan
- Planned elective open incisional hernia repair
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fast-track group Fast-track group Patients treated according to the enhanced recovery pathway. This group is examined prospectively.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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.
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)
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
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.
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.
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.
Trial Locations
- Locations (1)
Bispebjerg Hospital
🇩🇰Copenhagen NV, Copenhagen, Denmark