NCT05379751

Surgical Repair of Spigelian Hernia in a Cohort of Patients

Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Cagliari · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Spigelian Hernia

Interventions

Type	Name	Description
PROCEDURE	Fixation 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

Timeline

• Start date: 2015-12-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2022-05-18
• Last updated: 2022-05-18

Regulatory

• FDA-regulated device study