Spigelian HerniaNCT05379751
Surgical Repair of Spigelian Hernia in a Cohort of Patients
A study testing Fixation free Spigelian hernia repair with tentacle mesh in people with Spigelian Hernia, run by University of Cagliari.
Trial summary
Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spigelian Hernia
- What is being tested?
- Fixation free Spigelian hernia repair with tentacle mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with Spigelian hernia
Who cannot join
- Patients not having Spigelian hernia,
About this study
Official title: Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair
Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure
Read the detailed description
The surgical treatment of Spigelian hernias is mainly carried out with prosthetic meshes made of biocompatible material. In prosthetic repair of abdominal protrusions, mesh fixation and overlap of the mesh are source of complications. To avoid these problems, for a fixation free repair of Spigelian hernias has been developed a tentacle shaped implant, that should also assure a broader defect overlap. This study should highlight in a cohort of patients the long-term results of fixation free repair of Spigelian hernias carried out with tentacle mesh.
- Conditions
- Spigelian Hernia
- Being tested
- Fixation free Spigelian hernia repair with tentacle mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation free Spigelian hernia repair with tentacle meshProcedure or surgery
Spigelian hernias are repaired through the fixation free placement of a tentacle mesh in preperitoneal sublay thanks the friction exerted by the tentacle straps delivered by a proprietary needle passer crossing trouh the abdominal wall from the preperitoneal space until the subutaneous layer. This procedural approach should also grant a broad overlap of the implant over the hernial defect
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh | Experimental | Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS Receives: Procedure: Fixation free Spigelian hernia repair with tentacle mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation free prosthetic repair of Spigelian hernias with tentacle mesh
Feasibility of fixation free placement of tentacle mesh in Spigelian hernia repair
Measured: Intraoperative
Granting a broad implant overlap in prosthetic repair of Spigelian hernias with tentacle mesh
Granting a broad overlap over the hernial defect after placement in preperitoneal sublay of tentacle mesh in Spigelian hernia repair with tentacle mesh to reduce risks of recurrence in the long term postop.
Measured: between 6 and 84 months postop
Secondary outcomes (3)
Intra-operative features
reduction of the operative time length
Measured: intraoperatively
Postoperative features 1
Postoperative pain assessment with VAS scoring system
Measured: between 6 and 84 months postop
Postoperative features 2
Assessment of postoperative complications
Measured: between 6 and 84 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Dec 2015
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spigelian 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
- Not applicable
- Intervention model
- Single group
- Model description
- A cohort of 54 patients diagnosed with Spigelian hernia who underwent open surgical repair with the tentacle shaped implant (Freedom Octomesh VHR XS produced by Insightra Medical Inc. - USA) forms the body of this study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Amato, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379751
- Sponsor's protocol ID
- Spigelian hernia treatment
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair
- ClinicalTrials.gov ID
- NCT05379751
- Acronym / sponsor ID
- Spigelian hernia treatment
- Conditions
- Spigelian Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 18 May 2022 (actual)
- 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.
Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure
Detailed description
The surgical treatment of Spigelian hernias is mainly carried out with prosthetic meshes made of biocompatible material. In prosthetic repair of abdominal protrusions, mesh fixation and overlap of the mesh are source of complications. To avoid these problems, for a fixation free repair of Spigelian hernias has been developed a tentacle shaped implant, that should also assure a broader defect overlap. This study should highlight in a cohort of patients the long-term results of fixation free repair of Spigelian hernias carried out with tentacle mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A cohort of 54 patients diagnosed with Spigelian hernia who underwent open surgical repair with the tentacle shaped implant (Freedom Octomesh VHR XS produced by Insightra Medical Inc. - USA) forms the body of this study
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh | Experimental | Procedure: Fixation free Spigelian hernia repair with tentacle meshPatients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Spigelian hernia
Key exclusion criteria (1 listed)
- Patients not having Spigelian hernia,
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 |
|---|---|---|
| Fixation free Spigelian hernia repair with tentacle meshSpigelian hernias are repaired through the fixation free placement of a tentacle mesh in preperitoneal sublay thanks the friction exerted by the tentacle straps delivered by a proprietary needle passer crossing trouh the abdominal wall from the preperitoneal space until the subutaneous layer. This procedural approach should also grant a broad overlap of the implant over the hernial defect | Procedure or surgery | Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh |
Primary outcome
Fixation free prosthetic repair of Spigelian hernias with tentacle mesh
Time frame: Intraoperative
Feasibility of fixation free placement of tentacle mesh in Spigelian hernia repair
Granting a broad implant overlap in prosthetic repair of Spigelian hernias with tentacle mesh
Time frame: between 6 and 84 months postop
Granting a broad overlap over the hernial defect after placement in preperitoneal sublay of tentacle mesh in Spigelian hernia repair with tentacle mesh to reduce risks of recurrence in the long term postop.
3 secondary outcomes
Intra-operative features
Time frame: intraoperatively
Postoperative features 1
Time frame: between 6 and 84 months postop
Postoperative features 2
Time frame: between 6 and 84 months postop
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 18 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation free Spigelian hernia repair with tentacle mesh in people with Spigelian Hernia, run by University of Cagliari.
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 1 inclusion and 1 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Fixation free prosthetic repair of Spigelian hernias with tentacle mesh (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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 18 May 2022.