Inguinal HerniaNCT01637818
Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair
A study testing Lichtenstein's operation, Mesh Plug Repair and Opiate in people with Inguinal Hernia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. Read more about this study
- Who is it for?
- Ages 39 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein's operation, Mesh Plug Repair and Opiate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 1999to 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 39 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).
- provision of written informed consent,
- symptomatic unilateral or bilateral inguinal hernia.
Who cannot join
- presence of a femoral hernia,
- history of hernia repair with mesh,
- type I diabetes,
- presence of local or diffuse infection (urine, skin, lung, sepsis),
- immune deficiency,
- severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,
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- pregnancy,
- malignant tumours and
- life expectancy of less than 2 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair
Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."
Primary endpoints is recurrence.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein's operation, Mesh Plug Repair, Opiate, Paracetamol, non-steroidal anti-inflammatory drug
- Keywords
- Inguinal hernia repair, long-term follow-up, Surgical technique
- 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's operationProcedure or surgery
Mesh Plug RepairProcedure or surgery
OpiateDrug
Postoperative pain therapy
ParacetamolDrug
Postoperative pain therapy
non-steroidal anti-inflammatory drugDrug
Postoperative pain therapy
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein's Operation | Other | Not described Receives: Procedure: Lichtenstein's operation; Drug: Opiate; Drug: Paracetamol; Drug: non-steroidal anti-inflammatory drug |
| Mesh Plug Repair | Other | Not described Receives: Procedure: Mesh Plug Repair; Drug: Opiate; Drug: Paracetamol; Drug: non-steroidal anti-inflammatory drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)
Measured: 6 years
Secondary outcomes (3)
Pain
Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)
Measured: 6 years
Reoperation
Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)
Measured: 6 years
Sensitivity
Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startSep 1999
- Primary completionDec 2007
- 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.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland, Kantonsspital Olten, Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
- Responsible party
- Principal investigator, Raoul Droeser, University Hospital, Basel, Switzerland
- Investigators
- Daniel M Frey, MD, Principal investigator, GZO WetzikonMarkus Zuber, Prof., Principal investigator, Kantonsspital OltenJürg Metzger, Prof., Principal investigator, Luzerner KantonsspitalRachel Rosenthal, Prof., Principal investigator, University Hospital, Basel, SwitzerlandRaoul Droeser, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637818
- Sponsor's protocol ID
- R59
- Status last verified
- Jul 2012
- First submitted
- 6 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frey DM, Wildisen A, Hamel CT, Zuber M, Oertli D, Metzger J. Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41. doi: 10.1002/bjs.5580.
PubMed 17094166Droeser RA, Dell-Kuster S, Kurmann A, Rosenthal R, Zuber M, Metzger J, Oertli D, Hamel CT, Frey DM. Long-term follow-up of a randomized controlled trial of Lichtenstein's operation versus mesh plug repair for inguinal hernia. Ann Surg. 2014 May;259(5):966-72. doi: 10.1097/SLA.0000000000000297.
PubMed 24169195
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01637818
- Acronym / sponsor ID
- R59
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia repair, long-term follow-up, Surgical technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland, Kantonsspital Olten, Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
- Study start
- Sep 1999
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Jul 2012 (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.
Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."
Primary endpoints is recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein's Operation | Other | Procedure: Lichtenstein's operation, Drug: Opiate, Drug: Paracetamol, Drug: non-steroidal anti-inflammatory drug |
| Mesh Plug Repair | Other | Procedure: Mesh Plug Repair, Drug: Opiate, Drug: Paracetamol, Drug: non-steroidal anti-inflammatory drug |
Who may qualify
- Ages
- 39 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).
- provision of written informed consent,
- symptomatic unilateral or bilateral inguinal hernia.
Key exclusion criteria (9 listed)
- presence of a femoral hernia,
- history of hernia repair with mesh,
- type I diabetes,
- presence of local or diffuse infection (urine, skin, lung, sepsis),
- immune deficiency,
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's operation | Procedure or surgery | Lichtenstein's Operation |
| Mesh Plug Repair | Procedure or surgery | Mesh Plug Repair |
| OpiatePostoperative pain therapy | Drug | Lichtenstein's Operation, Mesh Plug Repair |
| ParacetamolPostoperative pain therapy | Drug | Lichtenstein's Operation, Mesh Plug Repair |
| non-steroidal anti-inflammatory drugPostoperative pain therapy | Drug | Lichtenstein's Operation, Mesh Plug Repair |
Primary outcome
Recurrence
Time frame: 6 years
Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)
3 secondary outcomes
Pain
Time frame: 6 years
Reoperation
Time frame: 6 years
Sensitivity
Time frame: 6 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 12 Jul 2012.
- Results publication: PubMed 17094166Frey DM, Wildisen A, Hamel CT, Zuber M, Oertli D, Metzger J. Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41. doi: 10.1002/bjs.5580.
- Derived from this study: PubMed 24169195Droeser RA, Dell-Kuster S, Kurmann A, Rosenthal R, Zuber M, Metzger J, Oertli D, Hamel CT, Frey DM. Long-term follow-up of a randomized controlled trial of Lichtenstein's operation versus mesh plug repair for inguinal hernia. Ann Surg. 2014 May;259(5):966-72. doi: 10.1097/SLA.0000000000000297.
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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.
Daniel M Frey, MD principal investigator
GZO Wetzikon
Markus Zuber, Prof. principal investigator
Kantonsspital Olten
Jürg Metzger, Prof. principal investigator
Luzerner Kantonsspital
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's operation, Mesh Plug Repair and Opiate in people with Inguinal Hernia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 9 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 12 Jul 2012. 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 Switzerland. 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 (time frame: 6 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 NCT01637818, 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 12 Jul 2012.