Hernia, VentralNCT02305082
Fast-track Giant Ventral Hernia Repair
An observational study of Hernia, Ventral, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Fast-track group
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are scheduled to undergo elective incisional hernia repair.
Who may be able to join
- Horizontal fascia defect > 10 cm on computed tomography scan
- Planned elective open incisional hernia repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hernia, Ventral
- Being tested
- Fast-track group
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-track groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fast-track group | Patients treated according to the enhanced recovery pathway. This group is examined prospectively. Receives: Other: Fast-track group | |
| Control group | Patients treated according to the historic recovery pathway. This group is examined retrospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
Time from surgery to discharge [Hours].
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes (11)
Fatigue
Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No fatigue, 5 = Exhausted).
Measured: Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain from supine to standing
Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery and for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kiim Jensen, Bispebjerg Hospital
- Investigators
- Kristian K Jensen, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305082
- Sponsor's protocol ID
- Fast-track-hernia-bbh
- Status last verified
- Sep 2015
- First submitted
- 11 Nov 2014
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Giant Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02305082
- Acronym / sponsor ID
- Fast-track-hernia-bbh
- Conditions
- Hernia, Ventral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track group | – | Other: Fast-track groupPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are scheduled to undergo elective incisional hernia repair.
Key inclusion criteria (2 listed)
- Horizontal fascia defect > 10 cm on computed tomography scan
- Planned elective open incisional hernia repair
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-track groupEnhanced 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. | Other | Fast-track group |
Primary outcome
Time to discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Time from surgery to discharge [Hours].
11 secondary outcomes
Fatigue
Time frame: Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain from supine to standing
Time frame: Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain when walking 6 meters
Time frame: Preoperative and for the duration of hospital stay, an expected average of 3 days
Nausea
Time frame: Preoperative and for the duration of hospital stay, an expected average of 3 days
Time to bowel function
Time frame: For the duration of postoperative hospital stay, an expected average of 72 hours
Vomiting episodes
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Continuous transcutaneous saturation
Time frame: From surgery to postoperative day 3 at 12 pm
C-reactive protein from venous blood sample
Time frame: Preoperative and for the duration of hospital stay, an expected average of 3 days
Ear temperature
Time frame: 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
Time frame: From surgery and for the duration of hospital stay, an expected average of 3 days
Daily wound drain production
Time frame: From surgery and for the duration of hospital stay, an expected average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian K Jensen, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Ventral, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge (time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.