Spigelian Hernia
Conditions
Brief summary
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.
Interventions
PROCEDUREFixation free Spigelian hernia repair with tentacle mesh
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
Sponsors
University of Cagliari
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with Spigelian hernia
Exclusion criteria
* Patients not having Spigelian hernia,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fixation free prosthetic repair of Spigelian hernias with tentacle mesh | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative features | intraoperatively | reduction of the operative time length |
| Postoperative features 1 | between 6 and 84 months postop | Postoperative pain assessment with VAS scoring system |
| Postoperative features 2 | between 6 and 84 months postop | Assessment of postoperative complications |
Outcome results
None listed