Hernia, InguinalPhase 4BOOPNCT00580177
PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results
A Phase 4 study testing Lichtenstein mesh, PerFix Plug® and Prolene® Hernia System in people with Hernia, Inguinal, run by Göteborg University at 1 site in Sweden.
Trial summary
Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Lichtenstein mesh, PerFix Plug® and Prolene® Hernia System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2000to Jul 2005
- Phase
- Phase 4
- 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 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-75 years
- Men
- Primary inguinal hernia
- ASA I-III
Who cannot join
- > 75 years
- Females
- ASA IV
- Previous ipsi-lateral hernia surgery
- Drug or alchol abuse
- Severe illness
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital
Gothenburg, Vastra Gotalandsregionen, SE-421 22
About this study
Official title: Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial
Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.
Read the detailed description
Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.
472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.
- Conditions
- Hernia, Inguinal
- Being tested
- Lichtenstein mesh, PerFix Plug®, Prolene® Hernia System
- Keywords
- Inguinal hernia, Randomized controlled trial, Surgery, Complications, Surgical mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein meshProcedure or surgery
Also called Inguinal hernioplasty (surgical repair of inguinal hernia)
The different techniques are compared and evaluated according to primary and secondary objectives.
PerFix Plug®Procedure or surgery
Also called Inguinal hernioplasty (surgical repair of inguinal hernia)
The different techniques are compared and evaluated according to primary and secondary objectives.
Prolene® Hernia SystemProcedure or surgery
Also called Inguinal hernioplasty (surgical repair of inguinal hernia)
The different techniques are compared and evaluated according to primary and secondary objectives.
| Study group | Role | What they receive |
|---|---|---|
| L | Active comparator | The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch) Receives: Procedure: Lichtenstein mesh |
| P | Active comparator | The well-konown PerFixPlug technique for inguinal hernia repair. Receives: Procedure: PerFix Plug® |
| PHS | Active comparator | The well-known Prolene Hernia System method for inguinal hernia repair. Receives: Procedure: Prolene® Hernia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until full functional recovery
Measured: 2 weeks, 3 months, 1 year, 3 years
Operation time
Measured: Registered after completion of surgery
Pain after operation measured on a VAS-scale and amount of consumed analgesics
Measured: Day 1-14, 3 months, 1 year, 3 years after surgery
Secondary outcomes (2)
Complication rate
Measured: 2 weeks, 3 months, 1 year, 3 years
Aptness for beeing performed under local anaesthesia
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJan 2000
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Investigators
- Jan A Dalenbäck, Ass. Prof., Principal investigator, Frolunda Specialist Hospital, University of GothenburgJan A Dalenbäck, Ass. Prof., Study director, Frolunda Specialist Hospital, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580177
- Sponsor's protocol ID
- FSS BOOP
- Acronym
- BOOP
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 24 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00580177
- Acronym / sponsor ID
- BOOP / FSS BOOP
- Conditions
- Hernia, Inguinal
- Keywords
- Inguinal hernia, Randomized controlled trial, Surgery, Complications, Surgical mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 24 Dec 2007 (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.
Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.
Detailed description
Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.
472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L | Active comparator | Procedure: Lichtenstein meshThe Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch) |
| P | Active comparator | Procedure: PerFix Plug®The well-konown PerFixPlug technique for inguinal hernia repair. |
| PHS | Active comparator | Procedure: Prolene® Hernia SystemThe well-known Prolene Hernia System method for inguinal hernia repair. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-75 years
- Men
- Primary inguinal hernia
- ASA I-III
Key exclusion criteria (6 listed)
- > 75 years
- Females
- ASA IV
- Previous ipsi-lateral hernia surgery
- Drug or alchol abuse
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 |
|---|---|---|
| Lichtenstein meshAlso: Inguinal hernioplasty (surgical repair of inguinal hernia)The different techniques are compared and evaluated according to primary and secondary objectives. | Procedure or surgery | L |
| PerFix Plug®Also: Inguinal hernioplasty (surgical repair of inguinal hernia)The different techniques are compared and evaluated according to primary and secondary objectives. | Procedure or surgery | P |
| Prolene® Hernia SystemAlso: Inguinal hernioplasty (surgical repair of inguinal hernia)The different techniques are compared and evaluated according to primary and secondary objectives. | Procedure or surgery | PHS |
Primary outcome
Time until full functional recovery
Time frame: 2 weeks, 3 months, 1 year, 3 years
Operation time
Time frame: Registered after completion of surgery
Pain after operation measured on a VAS-scale and amount of consumed analgesics
Time frame: Day 1-14, 3 months, 1 year, 3 years after surgery
2 secondary outcomes
Complication rate
Time frame: 2 weeks, 3 months, 1 year, 3 years
Aptness for beeing performed under local anaesthesia
Time frame: During surgery
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 24 Dec 2007.
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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.
Jan A Dalenbäck, Ass. Prof. principal investigator
Frolunda Specialist Hospital, University of Gothenburg
Jan A Dalenbäck, Ass. Prof. study director
Frolunda Specialist Hospital, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lichtenstein mesh, PerFix Plug® and Prolene® Hernia System in people with Hernia, Inguinal, run by Göteborg University 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 4 inclusion and 6 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 24 Dec 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time until full functional recovery (time frame: 2 weeks, 3 months, 1 year, 3 years). The study lists 3 primary outcomes in all. 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 24 Dec 2007.