Surgical Repair of Spigelian Hernia in a Cohort of Patients

NCT ID: NCT05379751

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2022-05-01

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.

Conditions

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Spigelian Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Fixation free Spigelian hernia repair with tentacle mesh

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with Spigelian hernia

Exclusion Criteria

* Patients not having Spigelian hernia,
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Amato

Consultant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Spigelian hernia treatment

Identifier Type: -

Identifier Source: org_study_id

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