Hernia, VentralPOSARNCT02594241
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
A study testing Methyl-Prednisolone and Physiological saline in people with Hernia, Ventral, run by Kristian Kiim Jensen at 1 site in Denmark.
Trial summary
Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be randomized to either methylprednisolone or saline preoperatively, to examine the effects of methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Methyl-Prednisolone and Physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to Nov 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ventral incisional hernia with horizontal fascial defect > 10 cm described at either computed tomography scan or clinical assessment
- Planned elective open hernia repair
- Ability to speak and understand Danish
- Ability to give written and oral informed consent
Who cannot join
- Daily use of systemic glucocorticoid
- New York Heart Association class 3-4 heart disease
- Chronic renal failure (eGFR < 60 ml/min per 1.73 m2)
- Insulin-dependent diabetes
- Excessive abuse of alcohol
- Known allergy to methylprednisolone or any substance in study medicine
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- Planned pregnancy within three months postoperatively
- Pregnancy, evaluated by pregnancy test preoperatively
- Breastfeeding
- Actively treated ulcer disease up to one month preoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be randomized to either methylprednisolone or saline preoperatively, to examine the effects of methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia repair.
Read the detailed description
Preoperative high-dose glucocorticoid has been shown to attenuate the postoperative inflammatory response leading to decreased morbidity and length of stay (LOS) after colorectal and aortic surgery, as well as decreased pain and subjective recovery after orthopedic surgery. Methylprednisolone (MP, "Solu-Medrol") is one such glucocorticoid, which has been shown to be safe for usage in surgery. Giant ventral hernia repair is associated with a high risk of postoperative morbidity and prolonged LOS compared with other hernia repair procedures requiring laparotomy. Further, the total costs of these procedures remain high. Systemic administration of high-dose preoperative MP in ventral hernia repair has only been described anecdotally in the literature, and never with the aim to improve the treatment of this patient group specifically. It is however unknown to what extent benefits weigh out downsides from usage of high-dose MP in giant ventral hernia repair, patients often at increased risk of postoperative wound infection. On this background we hypothesize that a preoperative high-dose MP results in improved recovery after giant ventral hernia repair compared with placebo.
- Conditions
- Hernia, Ventral
- Being tested
- Methyl-Prednisolone, Physiological saline
- Keywords
- Ventral hernia, Abdominal wall reconstruction, Enhanced recovery after surgery, Steroid
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl-PrednisoloneDrug
Also called Solu-Medrol
Single-shot 125 mg infusion given immediately after induction of anesthesia.
Physiological salineDrug
Also called Physiological Saline 9 mg/ml, Fresenius Kabi
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Patients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia. Receives: Drug: Methyl-Prednisolone |
| Physiological saline | Placebo comparator | Patients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia. Receives: Drug: Physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest
Self-reported pain at rest on af numerical rating scale (0-10)
Measured: First postoperative day at 8 am
Secondary outcomes (9)
Pain at rest, after moving from supine to sitting position and when coughing
Self-reported pain at rest, after moving from supine to sitting position and when coughing on af numerical rating scale (0-10)
Measured: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Fatigue
Self-reported fatigue on a numerical rating scale (0-10)
Measured: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Nausea
Self-reported nausea on a numerical rating scale (0-10)
Measured: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Vomiting
Number of vomiting episodes
Measured: From randomization until postoperative day 5
Time to fulfillment of discharge criteria
Patient's assessment of discharge criteria
Measured: From randomization until postoperative day 5, assessed at 8 am and 8 pm
30-postoperative complications
Complications that require surgical or medical intervention
Measured: From randomization and until 30-days postoperatively
30-day readmission
Patient readmission
Measured: From randomization and until 30-days postoperatively
Rescue analgesia intake
Need for intake of rescue analgesia postoperatively
Measured: From randomization and until day 5 postoperatively
C-reactive protein
Serum C-reactive protein preoperatively and on postoperative day 1-3.
Measured: From day of randomization until postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionMay 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Kiim Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Kiim Jensen, Bispebjerg Hospital
- Investigators
- Kristian K Jensen, MD, Principal investigator, Bispebjerg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594241
- Sponsor's protocol ID
- 2015-806
- Acronym
- POSAR
- Status last verified
- Sep 2020
- First submitted
- 29 Oct 2015
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen KK, Brondum TL, Belhage B, Hensler M, Arnesen RB, Kehlet H, Jorgensen LN. Preoperative steroid in abdominal wall reconstruction: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5260.
PubMed 27477797
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02594241
- Acronym / sponsor ID
- POSAR / 2015-806
- Conditions
- Hernia, Ventral
- Keywords
- Ventral hernia, Abdominal wall reconstruction, Enhanced recovery after surgery, Steroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kristian Kiim JensenUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 3 Nov 2015 (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.
Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be randomized to either methylprednisolone or saline preoperatively, to examine the effects of methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia repair.
Detailed description
Preoperative high-dose glucocorticoid has been shown to attenuate the postoperative inflammatory response leading to decreased morbidity and length of stay (LOS) after colorectal and aortic surgery, as well as decreased pain and subjective recovery after orthopedic surgery. Methylprednisolone (MP, "Solu-Medrol") is one such glucocorticoid, which has been shown to be safe for usage in surgery. Giant ventral hernia repair is associated with a high risk of postoperative morbidity and prolonged LOS compared with other hernia repair procedures requiring laparotomy. Further, the total costs of these procedures remain high. Systemic administration of high-dose preoperative MP in ventral hernia repair has only been described anecdotally in the literature, and never with the aim to improve the treatment of this patient group specifically. It is however unknown to what extent benefits weigh out downsides from usage of high-dose MP in giant ventral hernia repair, patients often at increased risk of postoperative wound infection. On this background we hypothesize that a preoperative high-dose MP results in improved recovery after giant ventral hernia repair compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methyl-PrednisolonePatients in this arm will be given an intravenous infusion of 125 mg Methylprednisolone (Solu-Medrol) immediately after induction of general anesthesia. |
| Physiological saline | Placebo comparator | Drug: Physiological salinePatients in this arm will be given an intravenous infusion of saline immediately after induction of general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ventral incisional hernia with horizontal fascial defect > 10 cm described at either computed tomography scan or clinical assessment
- Planned elective open hernia repair
- Ability to speak and understand Danish
- Ability to give written and oral informed consent
Key exclusion criteria (10 listed)
- Daily use of systemic glucocorticoid
- New York Heart Association class 3-4 heart disease
- Chronic renal failure (eGFR < 60 ml/min per 1.73 m2)
- Insulin-dependent diabetes
- Excessive abuse of alcohol
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 |
|---|---|---|
| Methyl-PrednisoloneAlso: Solu-MedrolSingle-shot 125 mg infusion given immediately after induction of anesthesia. | Drug | Methylprednisolone |
| Physiological salineAlso: Physiological Saline 9 mg/ml, Fresenius KabiA single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery | Drug | Physiological saline |
Primary outcome
Pain at rest
Time frame: First postoperative day at 8 am
Self-reported pain at rest on af numerical rating scale (0-10)
9 secondary outcomes
Pain at rest, after moving from supine to sitting position and when coughing
Time frame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Fatigue
Time frame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Nausea
Time frame: 8 am and 8 pm pre- and postoperatively until postoperative day 5 and again on day 30
Vomiting
Time frame: From randomization until postoperative day 5
Time to fulfillment of discharge criteria
Time frame: From randomization until postoperative day 5, assessed at 8 am and 8 pm
30-postoperative complications
Time frame: From randomization and until 30-days postoperatively
30-day readmission
Time frame: From randomization and until 30-days postoperatively
Rescue analgesia intake
Time frame: From randomization and until day 5 postoperatively
C-reactive protein
Time frame: From day of randomization until postoperative day 3
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 29 Sep 2020.
- Derived from this study: PubMed 27477797Jensen KK, Brondum TL, Belhage B, Hensler M, Arnesen RB, Kehlet H, Jorgensen LN. Preoperative steroid in abdominal wall reconstruction: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5260.
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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, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methyl-Prednisolone and Physiological saline in people with Hernia, Ventral, run by Kristian Kiim Jensen 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 4 inclusion and 10 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 29 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
Pain at rest (time frame: First postoperative day at 8 am). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594241, which also lists 1 linked publication.
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 29 Sep 2020.