Fast-track Giant Ventral Hernia Repair
1 other identifier
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 7, 2015
September 1, 2015
7 months
November 11, 2014
September 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Fatigue
Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain from supine to standing
Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain when walking 6 meters
Preoperative and for the duration of hospital stay, an expected average of 3 days
Nausea
Preoperative and for the duration of hospital stay, an expected average of 3 days
Time to bowel function
For the duration of postoperative hospital stay, an expected average of 72 hours
- +6 more secondary outcomes
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
Patients who are scheduled to undergo elective incisional hernia repair.
You may qualify if:
- Horizontal fascia defect \> 10 cm on computed tomography scan
- Planned elective open incisional hernia repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen NV, Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristian K Jensen, MD
Bispebjerg Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PHD student
Study Record Dates
First Submitted
November 11, 2014
First Posted
December 2, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 7, 2015
Record last verified: 2015-09