Surgical Repair of Spigelian Hernia in a Cohort of Patients

Overview

Repair of Spigelian hernias with a tentacle shaped implant and highlighting the results of the procedure

Full Title of Study: “Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2022

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

  • 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

Arms, Groups and Cohorts

  • Experimental: Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh
    • Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients diagnosed with Spigelian hernia Exclusion Criteria:

  • Patients not having Spigelian hernia,

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cagliari
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giuseppe Amato, Consultant Professor – University of Cagliari

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.