Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair

NCT06298500 | Completed

• 1 other identifier: AAG-O-H-2115
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified.

Conditions

Inguinal Hernia

Keywords

laparoscopic mesh fixation; inguinal hernia repair surgery; Cyanoacrylate; Histoacryl®

Outcome Measures

Primary Outcomes (1)

• Hernia recurrence rate

  Describe the incidence of hernia recurrence following the application of Histoacryl® LapFix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. The incidence of hernia recurrence is documented from the medical records until 6 months postoperatively.

  until 6 months postoperatively

Secondary Outcomes (18)

• Delayed tissue adhesive polymerization

  intraoperatively

• Intraoperative bleeding requiring therapeutic measures

  intraoperatively

• Organ injury

  intraoperatively

• Hernia recurrence

  at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months

• Mesh migration

  at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months

Study Arms (1)

Histoacryl Lapfix

Histoacryl Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery

Device: hernia repair surgery

Interventions

hernia repair surgery DEVICE

In recent years, atraumatic mesh fixation with tissue adhesive has increasingly become the method of choice. It is the recommended mesh fixation method by the International Hernia Society Guidelines. In this study patients with inguinal hernia are treated by placing a prosthetic mesh in one of the layers of the abdominal wall to cover the weakness, the mesh is fixed by Histoacryl LapFix,

Also known as: laparoscopic mesh fixation with Histoacryl Lapfix - Cannula

Histoacryl Lapfix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) treated in the period June 2018 to March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery.

You may qualify if:

• Adult patients (≥18 years old)
• treated between June 2018 and March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery.

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (1)

Hospital San Juan de Dios

Santa Cruz de Tenerife, Tenerife, 38001, Spain

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: March 15, 2024
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)