Surgical Repair of Spigelian Hernia in a Cohort of Patients

Study Overview
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Brief Summary
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Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure

Detailed Description
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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.

Official Title
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Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair

Conditions
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Spigelian Hernia

Intervention / Treatment
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* Procedure: Fixation free Spigelian hernia repair with tentacle mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with Spigelian hernia Exclusion Criteria: Patients not having Spigelian hernia,
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh<br>Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS | Procedure: Fixation free Spigelian hernia repair with tentacle mesh<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fixation free prosthetic repair of Spigelian hernias with tentacle mesh | Feasibility of fixation free placement of tentacle mesh in Spigelian hernia repair | 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. | between 6 and 84 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative features | reduction of the operative time length | intraoperatively | 
| Postoperative features 1 | Postoperative pain assessment with VAS scoring system | between 6 and 84 months postop | 
| Postoperative features 2 | Assessment of postoperative complications | between 6 and 84 months postop |