Unilateral Simple Inguinal HerniaNCT02770703
Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh
A study testing DynaMesh visible mesh in people with Unilateral Simple Inguinal Hernia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Unilateral Simple Inguinal Hernia
- What is being tested?
- DynaMesh visible mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Mar 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with a primary symptomatic unilateral inguinal hernia.
- Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or open techniques (e.g. Lichtenstein) as judged by the treating surgeon
- Written informed consent
Who cannot join
- Previous inguinal hernia repair
- Bilateral inguinal hernia
- Femoral hernia repair
- Repair in local anesthetics,
- Previous abdominal surgery
- Children
Show all 12Show fewer
- Emergency surgery, e.g. incarcerated hernias
- Contraindication for MRI scans (e.g. Pacemakers and similar implants, cochlea implants, claustrophobia)
- Contraindications to usage of mesh e.g. known hypersensitivity or allergy
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- American Society of Anesthesiologists (ASA) classification higher or equal to 3
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Basel, Department of Surgery
Basel, 4031
About this study
Official title: Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh
Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.
Two of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control.
Read more
Until now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery.
In this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.
- Conditions
- Unilateral Simple Inguinal Hernia
- Being tested
- DynaMesh visible mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaMesh visible meshDevice
Implantation of a MRI visible mesh
| Study group | Role | What they receive |
|---|---|---|
| Open inguinal hernia repair (Lichtenstein) | Experimental | Open inguinal hernia repair using a DynaMesh visible mesh Receives: Device: DynaMesh visible mesh |
| Total extraperitoneal inguinal hernia repair (TEP) | Experimental | Total extraperitoneal inguinal hernia repair using a DynaMesh visible mesh Receives: Device: DynaMesh visible mesh |
| Trans abdominal preperitoneal hernia repair (TAPP) | Experimental | Trans abdominal preperitoneal hernia repair using a DynaMesh visible mesh Receives: Device: DynaMesh visible mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Mesh Position per MRI
Measured: 90 days postoperatively
Secondary outcomes (3)
Evaluation of Mesh Deformation per MRI
Measured: 90 days postoperatively
Groin pain using visual analogue scale
Measured: 0, 1, 90, 365 days postoperatively
Recurrence of hernia
Measured: 0, 1, 90, 365 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: USB is responsible party on behalf of the principal investigator (PI). As PI cannot be tracked (lost to follow-up), the USB as "sponsor" set "overall recruitment status" unless the PI can be identified or tracked.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Simple 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Mechera, MD, Principal investigator, University Hospital of Basel, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770703
- Sponsor's protocol ID
- BASEC 2016-00085
- Status last verified
- Mar 2022
- First submitted
- 11 May 2016
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh
- ClinicalTrials.gov ID
- NCT02770703
- Acronym / sponsor ID
- BASEC 2016-00085
- Conditions
- Unilateral Simple Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: USB is responsible party on behalf of the principal investigator (PI). As PI cannot be tracked (lost to follow-up), the USB as "sponsor" set "overall recruitment status" unless the PI can be identified or tracked.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 12 May 2016 (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.
Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.
Two of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control.
Until now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery.
In this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open inguinal hernia repair (Lichtenstein) | Experimental | Device: DynaMesh visible meshOpen inguinal hernia repair using a DynaMesh visible mesh |
| Total extraperitoneal inguinal hernia repair (TEP) | Experimental | Device: DynaMesh visible meshTotal extraperitoneal inguinal hernia repair using a DynaMesh visible mesh |
| Trans abdominal preperitoneal hernia repair (TAPP) | Experimental | Device: DynaMesh visible meshTrans abdominal preperitoneal hernia repair using a DynaMesh visible mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients with a primary symptomatic unilateral inguinal hernia.
- Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or open techniques (e.g. Lichtenstein) as judged by the treating surgeon
- Written informed consent
Key exclusion criteria (12 listed)
- Previous inguinal hernia repair
- Bilateral inguinal hernia
- Femoral hernia repair
- Repair in local anesthetics,
- Previous abdominal surgery
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 |
|---|---|---|
| DynaMesh visible meshImplantation of a MRI visible mesh | Device | Open inguinal hernia repair (Lichtenstein), Total extraperitoneal inguinal hernia repair (TEP), Trans abdominal preperitoneal hernia repair (TAPP) |
Primary outcome
Evaluation of Mesh Position per MRI
Time frame: 90 days postoperatively
3 secondary outcomes
Evaluation of Mesh Deformation per MRI
Time frame: 90 days postoperatively
Groin pain using visual analogue scale
Time frame: 0, 1, 90, 365 days postoperatively
Recurrence of hernia
Time frame: 0, 1, 90, 365 days postoperatively
Results and safety
The study was stopped early (reason given: USB is responsible party on behalf of the principal investigator (PI). As PI cannot be tracked (lost to follow-up), the USB as "sponsor" set "overall recruitment status" unless the PI can be identified or tracked.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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.
Robert Mechera, MD principal investigator
University Hospital of Basel, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynaMesh visible mesh in people with Unilateral Simple 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 12 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: stopped early, as of the sponsor's last update on 17 Mar 2022. 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 was stopped early (reason given: USB is responsible party on behalf of the principal investigator (PI). As PI cannot be tracked (lost to follow-up), the USB as "sponsor" set "overall recruitment status" unless the PI can be identified or tracked.). Results are not available in the source record.
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?
Evaluation of Mesh Position per MRI (time frame: 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2022.