Inguinal HerniaNCT00226161
Chronic Pain After Inguinal Herniorrhaphy
A study testing Inguinal herniorrhaphy in people with Inguinal Hernia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Inguinal herniorrhaphy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to Sep 2013
- 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 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- Primary inguinal hernia
Who cannot join
- History of severe mental illness or chronic pain elsewhere
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgical Gastroenterology, Gentofte University Hospital,
Hellerup, 2900
About this study
The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy.
- Conditions
- Inguinal Hernia
- Being tested
- Inguinal herniorrhaphy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal herniorrhaphyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Secondary outcomes (1)
Recurrence of the hernia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Jacob Rosenberg, professor,dr.med,chief consul, Study director, Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226161
- Sponsor's protocol ID
- 171178
- Status last verified
- Sep 2005
- First submitted
- 22 Sep 2005
- Last updated
- 28 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT00226161
- Acronym / sponsor ID
- 171178
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2013
- Study completion
- Sep 2013
- First posted
- 26 Sep 2005 (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 purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary inguinal hernia
Key exclusion criteria (1 listed)
- History of severe mental illness or chronic pain elsewhere
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 |
|---|---|---|
| Inguinal herniorrhaphy | Procedure or surgery | – |
Primary outcome
Chronic pain
1 secondary outcome
Recurrence of the hernia
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
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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.
Jacob Rosenberg, professor,dr.med,chief consul study director
Gentofte University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inguinal herniorrhaphy in people with Inguinal Hernia, run by University Hospital, Gentofte, Copenhagen 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Jan 2013. 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 was stopped early. Results are not available in the source record.
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?
Chronic pain. 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 28 Jan 2013.