Inguinal HerniaPhase 3NCT01170780
Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
A Phase 3 study testing Dexamethasone and Saline in people with Inguinal Hernia and Femoral Hernia, run by Mette Astrup Madsen at 1 site in Denmark.
Trial summary
Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Inguinal Hernia, Femoral Hernia
- What is being tested?
- Dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 3
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients planned for elective laparoscopic hernia repair (TAPP)
- Unilateral inguinal or femoral hernia
- ASA class I-II
- Read and speak Danish
Who cannot join
- Acute hernia operation
- Operation for other hernias with mesh during the same procedure
- Endocrine disease (diabetes, adrenal insufficiency etc.)
- fever/infection within the first 10 days before operation
- Poor compliance
- No signed consent form
Show all 11Show fewer
- Daily intake of opioids or anxiolytic drugs
- Manic episodes
- Use medicine against glaucoma
- Use thiazide or loop diuretics
- Vaccination within the last 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.
- Conditions
- Inguinal Hernia, Femoral Hernia
- Being tested
- Dexamethasone, Saline
- Keywords
- Inguinal hernia, Transabdominal preperitoneal hernia repair, TAPP, Dexamethasone, Pain
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Fortecontin
single use of dexamethasone IV 8 mg/2 ml
SalineDrug
Also called Natriumchlorid, B. Braun 9 mg/ml
2 ml IV
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline Receives: Drug: Saline |
| Dexamethasone | Active comparator | Corticosteroid (Fortecontin 8 mg) Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during coughing
Assessed with visual analog scale (VAS 0-100 mm)
Measured: day 1
Secondary outcomes (8)
pain during coughing
Assessed with VAS
Measured: 4 days
pain at rest
Assessed with VAS
Measured: 4 days
convalescence
Registration of number of days after operation before returning to work and recreational activities.
Measured: 1 month
pain at rest
Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
Measured: 4 days
nausea
Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
Measured: 2 days
vomiting
yes/no question. If yes, how many times have you been vomiting?
Measured: 2 days
discomfort
Assessed with visual analog scale (VAS, 0-100 mm)
Measured: 4 days
fatigue
Assessed with numeric rating scale (NRS, 1-10)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionAug 2011
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 Inguinal HerniaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mette Astrup Madsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mette Astrup Madsen, Zealand University Hospital
- Investigators
- Mette A Tolver, M.D., Principal investigator, University Hospital KoegeThue Bisgaard, M.D. DMSc, Principal investigator, University Hospital Koege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170780
- Sponsor's protocol ID
- dx3
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2010
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tolver MA, Strandfelt P, Bryld EB, Rosenberg J, Bisgaard T. Randomized clinical trial of dexamethasone versus placebo in laparoscopic inguinal hernia repair. Br J Surg. 2012 Oct;99(10):1374-80. doi: 10.1002/bjs.8876.
PubMed 22961516
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01170780
- Acronym / sponsor ID
- dx3
- Conditions
- Inguinal Hernia, Femoral Hernia
- Keywords
- Inguinal hernia, Transabdominal preperitoneal hernia repair, TAPP, Dexamethasone, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mette Astrup MadsenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Jul 2010 (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.
Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline |
| Dexamethasone | Active comparator | Drug: DexamethasoneCorticosteroid (Fortecontin 8 mg) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients planned for elective laparoscopic hernia repair (TAPP)
- Unilateral inguinal or femoral hernia
- ASA class I-II
- Read and speak Danish
Key exclusion criteria (11 listed)
- Acute hernia operation
- Operation for other hernias with mesh during the same procedure
- Endocrine disease (diabetes, adrenal insufficiency etc.)
- fever/infection within the first 10 days before operation
- Poor compliance
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 |
|---|---|---|
| DexamethasoneAlso: Fortecontinsingle use of dexamethasone IV 8 mg/2 ml | Drug | Dexamethasone |
| SalineAlso: Natriumchlorid, B. Braun 9 mg/ml2 ml IV | Drug | Placebo |
Primary outcome
pain during coughing
Time frame: day 1
Assessed with visual analog scale (VAS 0-100 mm)
8 secondary outcomes
pain during coughing
Time frame: 4 days
pain at rest
Time frame: 4 days
convalescence
Time frame: 1 month
pain at rest
Time frame: 4 days
nausea
Time frame: 2 days
vomiting
Time frame: 2 days
discomfort
Time frame: 4 days
fatigue
Time frame: 4 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 26 Aug 2024.
- Derived from this study: PubMed 22961516Tolver MA, Strandfelt P, Bryld EB, Rosenberg J, Bisgaard T. Randomized clinical trial of dexamethasone versus placebo in laparoscopic inguinal hernia repair. Br J Surg. 2012 Oct;99(10):1374-80. doi: 10.1002/bjs.8876.
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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.
Mette A Tolver, M.D. principal investigator
University Hospital Koege
Thue Bisgaard, M.D. DMSc principal investigator
University Hospital Koege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Saline in people with Inguinal Hernia and Femoral Hernia, run by Mette Astrup Madsen 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 11 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 26 Aug 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 during coughing (time frame: day 1). 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 NCT01170780, 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 26 Aug 2024.