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

August 19, 2025 updated by: Aesculap AG

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
443

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Oriol Estallo Sanz
  • Phone Number: +34935866200
  • Email: info@bbraun.com

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hernia recurrence rate
Time Frame: until 6 months postoperatively
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delayed tissue adhesive polymerization
Time Frame: intraoperatively
The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected.
intraoperatively
Intraoperative bleeding requiring therapeutic measures
Time Frame: intraoperatively
Bleeding that requires additional measures than normal practice for stopping the hemorrhage.
intraoperatively
Organ injury
Time Frame: intraoperatively
Cumulative Number of patients suffering from Injury of an organ adjacent to the defect.
intraoperatively
Hernia recurrence
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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)
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months

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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
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
Time Frame: until 6 months postoperatively
Patient requiring to be operated again for any reason.
until 6 months postoperatively
Mesh repositioning or removal
Time Frame: until 6 months postoperatively
Patient requiring being operated again for repositioning or removal of the Mesh
until 6 months postoperatively
Acute or chronic pain
Time Frame: until 6 months postoperatively
pain persisting beyond 6 months postoperatively re-quiring analgesic treatment
until 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aesculap AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
B.Braun Surgical SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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