Inguinal HerniaNCT01699971
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair
A study testing Hernia repair in people with Inguinal Hernia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2006to Mar 2012
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years
- unilateral primary hernia
- open surgery
Who cannot join
- Recurrent Hernia
- Bilateral Hernia
- laparoscopic surgery
- Female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study Comparing Three Different Techniques for Open
The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups
- Conditions
- Inguinal Hernia
- Being tested
- Hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia repairProcedure or surgery
Hernia repair admodum Lichtenstein with polypropylene mesh
Hernia repairProcedure or surgery
Hernia repair with Ultra Pro Hernia System (UHS)
Hernia repairProcedure or surgery
Hernia repair with Prolene Hernia System(PHS)
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein | Active comparator | Hernia repair with lichtenstein propylene mesh Receives: Procedure: Hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperatively pain
Visual analog scale (VAS)
Measured: Postoperative 36 month
Secondary outcomes (2)
Quality of life
SF36
Measured: 36 month postoperative
frequency of recurrencies
check patients journal
Measured: postopertive 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2006
- Primary completionMar 2009
- Study completionMar 2012
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Assoc Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699971
- Sponsor's protocol ID
- 2006/672-31/4
- Status last verified
- Sep 2012
- First submitted
- 1 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing Three Different Techniques for Open
- ClinicalTrials.gov ID
- NCT01699971
- Acronym / sponsor ID
- 2006/672-31/4
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Oct 2012 (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 primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein | Active comparator | Procedure: Hernia repairHernia repair with lichtenstein propylene mesh |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years
- unilateral primary hernia
- open surgery
Key exclusion criteria (4 listed)
- Recurrent Hernia
- Bilateral Hernia
- laparoscopic surgery
- Female
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 |
|---|---|---|
| Hernia repairHernia repair admodum Lichtenstein with polypropylene mesh | Procedure or surgery | Lichtenstein |
| Hernia repairHernia repair with Ultra Pro Hernia System (UHS) | Procedure or surgery | Lichtenstein |
| Hernia repairHernia repair with Prolene Hernia System(PHS) | Procedure or surgery | Lichtenstein |
Primary outcome
postoperatively pain
Time frame: Postoperative 36 month
Visual analog scale (VAS)
2 secondary outcomes
Quality of life
Time frame: 36 month postoperative
frequency of recurrencies
Time frame: postopertive 36 month
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 4 Oct 2012.
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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.
Anders Thorell, Assoc Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hernia repair in people with Inguinal Hernia, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 4 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 4 Oct 2012. 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 Sweden. 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?
postoperatively pain (time frame: Postoperative 36 month). 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 4 Oct 2012.