Recurrent Inguinal HerniaNCT00642200
Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty
A study testing Lichtenstein hernioplasty and Laparoscopic TEP in people with Recurrent Inguinal Hernia, run by North Karelia Central Hospital at 1 site in Finland.
Trial summary
The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Inguinal Hernia
- What is being tested?
- Lichtenstein hernioplasty and Laparoscopic TEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Jan 1997to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recurrent inguinal hernia
- willing to participate
Who cannot join
- unwilling to participate
- bilateral hernia
- preference towards either treatment arm
Trial locations and contacts
1 site in 1 country.
Finland1 site
North Karelia Central Hospital - Clinic of Surgery
Joensuu, Pohjois-Karjala, FI-80210
About this study
Official title: Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial
The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.
- Conditions
- Recurrent Inguinal Hernia
- Being tested
- Lichtenstein hernioplasty, Laparoscopic TEP
- 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 hernioplastyProcedure or surgery
Laparoscopic TEPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia. Receives: Procedure: Lichtenstein hernioplasty |
| 2 | Active comparator | Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia. Receives: Procedure: Laparoscopic TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
further recurrence
Measured: 3 weeks, 1 year, 2 years, 3 years
Secondary outcomes (1)
chronic pain or discomfort
Measured: 3 weeks, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJan 1997
- Primary completionFeb 2002
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kuopio Computing Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642200
- Sponsor's protocol ID
- NKCH-surg-001
- Status last verified
- May 2008
- First submitted
- 18 Mar 2008
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kouhia ST, Huttunen R, Silvasti SO, Heiskanen JT, Ahtola H, Uotila-Nieminen M, Kiviniemi VV, Hakala T. Lichtenstein hernioplasty versus totally extraperitoneal laparoscopic hernioplasty in treatment of recurrent inguinal hernia--a prospective randomized trial. Ann Surg. 2009 Mar;249(3):384-7. doi: 10.1097/SLA.0b013e318196d0b0.
PubMed 19247022
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00642200
- Acronym / sponsor ID
- NKCH-surg-001
- Conditions
- Recurrent Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Collaborators
- University of Kuopio Computing Center
- Study start
- Jan 1997
- Primary completion
- Feb 2002 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 24 Mar 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 study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.
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 hernioplastyPatients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia. |
| 2 | Active comparator | Procedure: Laparoscopic TEPPatients receive laparoscopic TEP as a treatment for recurrent inguinal hernia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- recurrent inguinal hernia
- willing to participate
Key exclusion criteria (3 listed)
- unwilling to participate
- bilateral hernia
- preference towards either treatment arm
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 hernioplasty | Procedure or surgery | 1 |
| Laparoscopic TEP | Procedure or surgery | 2 |
Primary outcome
further recurrence
Time frame: 3 weeks, 1 year, 2 years, 3 years
1 secondary outcome
chronic pain or discomfort
Time frame: 3 weeks, 1 year, 2 years, 3 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 22 May 2008.
- Derived from this study: PubMed 19247022Kouhia ST, Huttunen R, Silvasti SO, Heiskanen JT, Ahtola H, Uotila-Nieminen M, Kiviniemi VV, Hakala T. Lichtenstein hernioplasty versus totally extraperitoneal laparoscopic hernioplasty in treatment of recurrent inguinal hernia--a prospective randomized trial. Ann Surg. 2009 Mar;249(3):384-7. doi: 10.1097/SLA.0b013e318196d0b0.
Related trials for Recurrent Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruitingObservational study
Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair
Inguinal Hernia
Active, not recruitingObservational study
Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair
Hernia, Inguinal
Recruiting
Outcomes of Laparoscopic Keyhole Surgery (TAPP) for Recurrent Inguinal Hernia
Recurrant Inguinal Hernia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein hernioplasty and Laparoscopic TEP in people with Recurrent Inguinal Hernia, run by North Karelia Central Hospital at 1 site in Finland.
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 3 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 22 May 2008. 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 Finland. 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?
further recurrence (time frame: 3 weeks, 1 year, 2 years, 3 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 NCT00642200, which also lists 1 linked publication.
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 22 May 2008.