Hernia, InguinalNCT01020058
Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia
A study testing Mesh repair for primary inguinal hernia in people with Hernia, Inguinal, run by Uppsala University Hospital at 2 sites in Sweden.
Trial summary
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Mesh repair for primary inguinal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2006to Dec 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 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral inguinal hernia
- suitable for open mesh repair in local anesthesia as well as laparoscopic repair
- ASA score I-III
- informed consent
Who cannot join
- ASA score IV (not suitable for TEP)
- bilateral hernias (laparoscopic repair preferable)
- recurrent hernia (primary repair affects preferable treatment)
- large scrotal hernias (not suitable for local anesthesia)
- earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Enköping Hospital
Enköping, 75436
Uppsala University Hospital
Uppsala, 751 85
About this study
Official title: Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.
- Conditions
- Hernia, Inguinal
- Being tested
- Mesh repair for primary inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh repair for primary inguinal herniaProcedure or surgery
Also called Lichtenstein (LLA), TEP
Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein in local anesthesia (LLA) | Active comparator | Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein Receives: Procedure: Mesh repair for primary inguinal hernia |
| TEP | Active comparator | Patient receives a totally extraperitoneal laparoscopic repair Receives: Procedure: Mesh repair for primary inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term post operative pain
Measured: 6 wks, 1 year
Secondary outcomes (1)
cost-effectiveness of the separate procedures
Measured: 6wks, 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startApr 2006
- Primary completionMar 2012
- Study completionDec 2012
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 Hernia, InguinalStudies 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
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Ursula Dahlstrand, Uppsala University Hospital
- Investigators
- Staffan Wollert, MD, PhD, Study director, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020058
- Sponsor's protocol ID
- 2004:M-360
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2009
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Westin L, Wollert S, Ljungdahl M, Sandblom G, Gunnarsson U, Dahlstrand U. Less Pain 1 Year After Total Extra-peritoneal Repair Compared With Lichtenstein Using Local Anesthesia: Data From a Randomized Controlled Clinical Trial. Ann Surg. 2016 Feb;263(2):240-3. doi: 10.1097/SLA.0000000000001289.
PubMed 26079901Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.
PubMed 23572220
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia
- ClinicalTrials.gov ID
- NCT01020058
- Acronym / sponsor ID
- 2004:M-360
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Study start
- Apr 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Nov 2009 (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 compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein in local anesthesia (LLA) | Active comparator | Procedure: Mesh repair for primary inguinal herniaPatient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein |
| TEP | Active comparator | Procedure: Mesh repair for primary inguinal herniaPatient receives a totally extraperitoneal laparoscopic repair |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral inguinal hernia
- suitable for open mesh repair in local anesthesia as well as laparoscopic repair
- ASA score I-III
- informed consent
Key exclusion criteria (5 listed)
- ASA score IV (not suitable for TEP)
- bilateral hernias (laparoscopic repair preferable)
- recurrent hernia (primary repair affects preferable treatment)
- large scrotal hernias (not suitable for local anesthesia)
- earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)
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 |
|---|---|---|
| Mesh repair for primary inguinal herniaAlso: Lichtenstein (LLA), TEPOpen Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh | Procedure or surgery | Lichtenstein in local anesthesia (LLA), TEP |
Primary outcome
long-term post operative pain
Time frame: 6 wks, 1 year
1 secondary outcome
cost-effectiveness of the separate procedures
Time frame: 6wks, 1year
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 Jan 2016.
- Derived from this study: PubMed 26079901Westin L, Wollert S, Ljungdahl M, Sandblom G, Gunnarsson U, Dahlstrand U. Less Pain 1 Year After Total Extra-peritoneal Repair Compared With Lichtenstein Using Local Anesthesia: Data From a Randomized Controlled Clinical Trial. Ann Surg. 2016 Feb;263(2):240-3. doi: 10.1097/SLA.0000000000001289.
- Derived from this study: PubMed 23572220Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.
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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.
Staffan Wollert, MD, PhD study director
Uppsala University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh repair for primary inguinal hernia in people with Hernia, Inguinal, run by Uppsala University Hospital at 2 sites 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 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
long-term post operative pain (time frame: 6 wks, 1 year). 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 NCT01020058, 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 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.