Inguinal HerniaNCT00568269
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
A study testing Open repair and Laparoscopic repair in people with Inguinal Hernia, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Open repair and Laparoscopic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,513 participants
- Where
- 1 siteSweden
- Study dates
- Nov 1996to Dec 2007
- 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 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age 30-70 years referred to hospital with a primary inguinal hernia.
Who cannot join
- Recurrent hernia
- Scrotal or bilateral hernia
- Previous lower abdominal surgery
- Unable to participate in follow up
- ASA more than 3
- Bleeding diathesis.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centre for Clinical Research, Central hospital, entrance 29
Västerås, 721 89
About this study
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.
- Conditions
- Inguinal Hernia
- Being tested
- Open repair, Laparoscopic repair
- Keywords
- Recurrence rate after inguinal hernia repair on primary inguinal herina.
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repairProcedure or surgery
Open repair is according to the Lichtenstein technique
Laparoscopic repairProcedure or surgery
The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein | Active comparator | Not described Receives: Procedure: Open repair |
| TEP | Experimental | Not described Receives: Procedure: Laparoscopic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: 5 years
Secondary outcomes (1)
Operative complications, postoperative recovery and chronic pain at 5 years.
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 posted6 Dec 2007 (estimated)
- Study startNov 1996
- Study completionDec 2007
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.
- 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
- None (open label)
- Enrolment
- 1,513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stig and Ragna Gorthon Foundation, Tyco Healthcare Group
- Investigators
- Arne S Eklund, MD, Principal investigator, Centre for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568269
- Sponsor's protocol ID
- SMIL II
- Other IDs
- Ups 144-96
- Status last verified
- Dec 2007
- First submitted
- 5 Dec 2007
- Last updated
- 6 Dec 2007
- Results posted
- No
Publications
Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
PubMed 16862612Eklund A, Montgomery A, Bergkvist L, Rudberg C; Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy (SMIL) study group. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg. 2010 Apr;97(4):600-8. doi: 10.1002/bjs.6904.
PubMed 20186889
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
- ClinicalTrials.gov ID
- NCT00568269
- Acronym / sponsor ID
- SMIL II
- Conditions
- Inguinal Hernia
- Keywords
- Recurrence rate after inguinal hernia repair on primary inguinal herina.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,513 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Stig and Ragna Gorthon Foundation, Tyco Healthcare Group
- Study start
- Nov 1996
- Study completion
- Dec 2007 (actual)
- First posted
- 6 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.
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein | Active comparator | Procedure: Open repair |
| TEP | Experimental | Procedure: Laparoscopic repair |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male
- Age 30-70 years referred to hospital with a primary inguinal hernia.
Key exclusion criteria (6 listed)
- Recurrent hernia
- Scrotal or bilateral hernia
- Previous lower abdominal surgery
- Unable to participate in follow up
- ASA more than 3
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 |
|---|---|---|
| Open repairOpen repair is according to the Lichtenstein technique | Procedure or surgery | Lichtenstein |
| Laparoscopic repairThe TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair | Procedure or surgery | TEP |
Primary outcome
Recurrence rate
Time frame: 5 years
1 secondary outcome
Operative complications, postoperative recovery and chronic pain at 5 years.
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 6 Dec 2007.
- Results publication: PubMed 16862612Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
- Derived from this study: PubMed 20186889Eklund A, Montgomery A, Bergkvist L, Rudberg C; Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy (SMIL) study group. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg. 2010 Apr;97(4):600-8. doi: 10.1002/bjs.6904.
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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.
Arne S Eklund, MD principal investigator
Centre for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open repair and Laparoscopic repair in people with Inguinal Hernia, run by Uppsala University Hospital 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 2 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 6 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.
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?
Recurrence rate (time frame: 5 years). 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 NCT00568269, 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 6 Dec 2007.