Inguinal HerniaPhase 3LEVELNCT00788554
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein
A Phase 3 study testing Lichtenstein procedure and TEP in people with Inguinal Hernia, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein procedure and TEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2000to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- age > 18 years
- inguinal hernia(primary, recurrence or bilateral)
- elective procedure
Who cannot join
- Scrotal hernia
- Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
- Participation in other trial
- Pregnancy
- Communicative or cognitive restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.
The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein procedure, TEP
- Keywords
- groin, inguinal, hernia, lichtenstein, TEP
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein procedureProcedure or surgery
open surgical procedure for inguinal hernia correction
TEPProcedure or surgery
Total Exta Peritoneal procedure for inguinal hernia correction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Lichtenstein procedure |
| 2 | Active comparator | Not described Receives: Procedure: TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital stay
Measured: 7 days
postoperative pain
Measured: 6 weeks
return to work
Measured: 6 weeks
quality of life
Measured: 5 years
Secondary outcomes (6)
operating time
Measured: 1 day
operating costs
Measured: 1 week
complication
Measured: 1 month
mortality
Measured: 5 years
total costs
Measured: 1 month
recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startAug 2000
- Primary completionMar 2004
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hasan eker, Erasmus Medical Center
- Investigators
- J.F. Lange, professor, Principal investigator, Erasmus Medical CenterJ.J. Jeekel, professor, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788554
- Sponsor's protocol ID
- LEVEL
- Acronym
- LEVEL
- Status last verified
- Aug 2011
- First submitted
- 9 Nov 2008
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eker HH, Langeveld HR, Klitsie PJ, van't Riet M, Stassen LP, Weidema WF, Steyerberg EW, Lange JF, Bonjer HJ, Jeekel J. Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs Lichtenstein repair: a long-term follow-up study. Arch Surg. 2012 Mar;147(3):256-60. doi: 10.1001/archsurg.2011.2023.
PubMed 22430907Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.
PubMed 20395851
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT00788554
- Acronym / sponsor ID
- LEVEL / LEVEL
- Conditions
- Inguinal Hernia
- Keywords
- groin, inguinal, hernia, lichtenstein, TEP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Nov 2008 (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 aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Lichtenstein procedure |
| 2 | Active comparator | Procedure: TEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- age > 18 years
- inguinal hernia(primary, recurrence or bilateral)
- elective procedure
Key exclusion criteria (5 listed)
- Scrotal hernia
- Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
- Participation in other trial
- Pregnancy
- Communicative or cognitive restrictions
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 procedureopen surgical procedure for inguinal hernia correction | Procedure or surgery | 1 |
| TEPTotal Exta Peritoneal procedure for inguinal hernia correction | Procedure or surgery | 2 |
Primary outcome
hospital stay
Time frame: 7 days
postoperative pain
Time frame: 6 weeks
return to work
Time frame: 6 weeks
quality of life
Time frame: 5 years
6 secondary outcomes
operating time
Time frame: 1 day
operating costs
Time frame: 1 week
complication
Time frame: 1 month
mortality
Time frame: 5 years
total costs
Time frame: 1 month
recurrence
Time frame: 5 years
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 19 Aug 2011.
- Derived from this study: PubMed 22430907Eker HH, Langeveld HR, Klitsie PJ, van't Riet M, Stassen LP, Weidema WF, Steyerberg EW, Lange JF, Bonjer HJ, Jeekel J. Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs Lichtenstein repair: a long-term follow-up study. Arch Surg. 2012 Mar;147(3):256-60. doi: 10.1001/archsurg.2011.2023.
- Derived from this study: PubMed 20395851Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.
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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.
J.F. Lange, professor principal investigator
Erasmus Medical Center
J.J. Jeekel, professor principal investigator
Erasmus Medical Center
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 Lichtenstein procedure and TEP in people with Inguinal Hernia, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 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 19 Aug 2011. 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 Netherlands. 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 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?
hospital stay (time frame: 7 days). The study lists 4 primary outcomes in all. 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 NCT00788554, which also lists 2 linked publications.
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 19 Aug 2011.