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OpenTrials
Completed

NCT Number: NCT05379751

Surgical Repair of Spigelian Hernia in a Cohort of Patients

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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with Spigelian hernia

Exclusion criteria

  • Patients not having Spigelian hernia,

Treatment and study plan

Fixation free Spigelian hernia repair with tentacle mesh

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Intra-operative features

    Time frame: intraoperatively

    reduction of the operative time length

  2. Postoperative features 1

    Time frame: between 6 and 84 months postop

    Postoperative pain assessment with VAS scoring system

  3. Postoperative features 2

    Time frame: between 6 and 84 months postop

    Assessment of postoperative complications

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

Tentacle Shaped Mesh for Fixation Free Spigelian Hernia Repair

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
May 18, 2022
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.