Surgical Repair of Spigelian Hernia in a Cohort of Patients

Not Applicable

Completed

• Conditions: Spigelian Hernia
• Interventions: Procedure: Fixation free Spigelian hernia repair with tentacle mesh

• Registration Number: NCT05379751
• Lead Sponsor: University of Cagliari

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.

Study Timeline

• Study Start: 2015-12-01
• Status Verified: 2022-05
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-12
• Last Update Submitted: 2022-05-12
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients diagnosed with Spigelian hernia

Exclusion Criteria

• Patients not having Spigelian hernia,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh	Fixation free Spigelian hernia repair with tentacle mesh	Patients diagnosed with Spigelian hernia who underwent prosthetic repair with the tentacle mesh Freedom Octomesh VHR XS

Primary Outcome Measures

Name	Time	Method
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

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