Surgical Repair of Spigelian Hernia in a Cohort of Patients

Sponsor

University of Cagliari (Other)

Overall Status

Completed

CT.gov ID

NCT05379751

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spigelian Hernia	Procedure: Fixation free Spigelian hernia repair with tentacle mesh	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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 studyA 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with Spigelian hernia

Exclusion Criteria:

Patients not having Spigelian hernia,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giuseppe Amato, Consultant Professor, University of Cagliari

ClinicalTrials.gov Identifier:

NCT05379751

Other Study ID Numbers:

Spigelian hernia treatment

First Posted:

May 18, 2022

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Hernia

Study Results

No Results Posted as of May 18, 2022