Surgical Repair of Spigelian Hernia in a Cohort of Patients

May 12, 2022 updated by: Giuseppe Amato, University of Cagliari

Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with Spigelian hernia

Exclusion Criteria:

  • Patients not having Spigelian hernia,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperative
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.
between 6 and 84 months postop

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spigelian hernia treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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