Clinical trial NCT02305082: Fast-track Giant Ventral Hernia Repair
Official title: Fast-track Giant Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Ventral
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo elective incisional hernia repair.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes:
measure: Fatigue
timeFrame: Preoperative and for the duration of hospital stay, an expected average of 3 days
measure: Pain from supine to standing
timeFrame: Preoperative and for the duration of hospital stay, an expected average of 3 days
measure: Pain when walking 6 meters
timeFrame: Preoperative and for the duration of hospital stay, an expected average of 3 days
measure: Nausea
timeFrame: Preoperative and for the duration of hospital stay, an expected average of 3 days
measure: Time to bowel function
timeFrame: For the duration of postoperative hospital stay, an expected average of 72 hours
measure: Vomiting episodes
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Continuous transcutaneous saturation
timeFrame: From surgery to postoperative day 3 at 12 pm
measure: C-reactive protein from venous blood sample
timeFrame: Preoperative and for the duration of hospital stay, an expected average of 3 days
measure: Ear temperature
timeFrame: Preoperative and for the duration of hospital stay, an expected average of 3 days
measure: Detailed reason for not being discharged if criteria are otherwise fulfilled
timeFrame: From surgery and for the duration of hospital stay, an expected average of 3 days
measure: Daily wound drain production
timeFrame: From surgery and for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: Bispebjerg Hospital
name: Kristian K Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: