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

Retrospective, Single Center Clinical Study on the Clinical Performance of Histoacryl® Lapfix - Cannula for Laparoscopic Inguinal Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Device: hernia repair surgery

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• Spain
  • Tenerife
    • Santa Cruz De Tenerife, Tenerife, Spain, 38001
      • Hospital San Juan de Dios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• No exclusion criteria has been set.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: hernia repair surgery; 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,; Other Names: laparoscopic mesh fixation with Histoacryl Lapfix - Cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed tissue adhesive polymerization	The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected.	intraoperatively
Intraoperative bleeding requiring therapeutic measures	Bleeding that requires additional measures than normal practice for stopping the hemorrhage.	intraoperatively
Organ injury	Cumulative Number of patients suffering from Injury of an organ adjacent to the defect.	intraoperatively
Hernia recurrence	Cumulative Number of Hernia recurring again after repair	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Mesh migration	Cumulative Number of patients in whom Mesh has moved from its original position	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Adhesions	Cumulative Number of patients in whom tissue is adhered and allows no physiological movement	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Erosion	Cumulative Number of patients suffering from a mesh erosion into the bladder/urethra include painful voiding, urinary frequency, urgency, hematuria, recurrent urinary tract infection, urinary calculi and urinary fistula.	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Meshoma formation	Cumulative Number of patients suffering from a wrinkling of the mesh that causes pain or hernia recurrence. Nerve entrapment or damage. Rejection of the mesh implant.	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Tack hernias	Cumulative Number of patients requiring tack fixation was needed	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Surgical Site Infection (superficial, deep, intraabdominal)	Cumulative Number of patients suffering from Surgical Site Infection classified according on Center for Disease Control and Prevention criteria (A1: superficial, A2: deep, A3: organ/space)	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Hematoma	Cumulative Number of patients suffering from a solid swelling of clotted blood within the tissues.	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Seroma	Cumulative Number of patients suffering from a mass or lump caused by a buildup of clear fluid in a tissue, organ or body cavity	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Hemorrhage	Cumulative Number of patients suffering from an escape of blood from a ruptured blood vessel.	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Orchitis	Cumulative Number of patients suffering from inflammation of the testicles	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Other Adverse Event	Cumulative Number of any other adverse event not mentioned.	at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Reintervention	Patient requiring to be operated again for any reason.	until 6 months postoperatively
Mesh repositioning or removal	Patient requiring being operated again for repositioning or removal of the Mesh	until 6 months postoperatively
Acute or chronic pain	pain persisting beyond 6 months postoperatively re-quiring analgesic treatment	until 6 months postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cyanoacrylate; inguinal hernia repair surgery; laparoscopic mesh fixation; Histoacryl®
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: AAG-O-H-2115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No