Back to resultsSurgical Repair of Spigelian Hernia in a Cohort of Patients
Primary Purpose
Spigelian Hernia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fixation free Spigelian hernia repair with tentacle mesh
Sponsored by
About this trial
This is an interventional treatment trial for Spigelian Hernia
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with Spigelian hernia
Exclusion Criteria:
- Patients not having Spigelian hernia,
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh
Arm Description
Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS
Outcomes
Primary Outcome Measures
Fixation free prosthetic repair of Spigelian hernias with tentacle mesh
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
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
reduction of the operative time length
Postoperative features 1
Postoperative pain assessment with VAS scoring system
Postoperative features 2
Assessment of postoperative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05379751
Brief Title
Surgical Repair of Spigelian Hernia in a Cohort of Patients
Official Title
Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spigelian Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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 study
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh
Arm Type
Experimental
Arm Description
Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS
Intervention Type
Procedure
Intervention Name(s)
Fixation free Spigelian hernia repair with tentacle mesh
Intervention Description
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
Primary Outcome Measure Information:
Title
Fixation free prosthetic repair of Spigelian hernias with tentacle mesh
Description
Feasibility of fixation free placement of tentacle mesh in Spigelian hernia repair
Time Frame
Intraoperative
Title
Granting a broad implant overlap in prosthetic repair of Spigelian hernias with tentacle mesh
Description
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.
Time Frame
between 6 and 84 months postop
Secondary Outcome Measure Information:
Title
Intra-operative features
Description
reduction of the operative time length
Time Frame
intraoperatively
Title
Postoperative features 1
Description
Postoperative pain assessment with VAS scoring system
Time Frame
between 6 and 84 months postop
Title
Postoperative features 2
Description
Assessment of postoperative complications
Time Frame
between 6 and 84 months postop
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with Spigelian hernia
Exclusion Criteria:
Patients not having Spigelian hernia,
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Repair of Spigelian Hernia in a Cohort of Patients
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