Inguinal HerniaHISTOLAPNCT06298500
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Aesculap AG at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- hernia repair surgery
- Type of treatment
- Medical device
- How many people
- 443 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2024to 7 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria has been set.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Inguinal Hernia
- Being tested
- hernia repair surgery
- Keywords
- laparoscopic mesh fixation, inguinal hernia repair surgery, Cyanoacrylate, Histoacryl®
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernia repair surgeryDevice
Also called laparoscopic mesh fixation with Histoacryl Lapfix - Cannula
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,
| Study group | Role | What they receive |
|---|---|---|
| Histoacryl Lapfix | Histoacryl Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery Receives: Device: hernia repair surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until 6 months postoperatively
Secondary outcomes (18)
Delayed tissue adhesive polymerization
The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected.
Measured: intraoperatively
Intraoperative bleeding requiring therapeutic measures
Bleeding that requires additional measures than normal practice for stopping the hemorrhage.
Measured: intraoperatively
Organ injury
Cumulative Number of patients suffering from Injury of an organ adjacent to the defect.
Measured: intraoperatively
Hernia recurrence
Cumulative Number of Hernia recurring again after repair
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: until 6 months postoperatively
Mesh repositioning or removal
Patient requiring being operated again for repositioning or removal of the Mesh
Measured: until 6 months postoperatively
Acute or chronic pain
pain persisting beyond 6 months postoperatively re-quiring analgesic treatment
Measured: until 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Mar 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298500
- Sponsor's protocol ID
- AAG-O-H-2115
- Acronym
- HISTOLAP
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Single Center Clinical Study on the Clinical Performance of Histoacryl® Lapfix - Cannula for Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06298500
- Acronym / sponsor ID
- HISTOLAP / AAG-O-H-2115
- Conditions
- Inguinal Hernia
- Keywords
- laparoscopic mesh fixation, inguinal hernia repair surgery, Cyanoacrylate, Histoacryl®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histoacryl Lapfix | – | Device: hernia repair surgeryHistoacryl Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria has been set.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hernia repair surgeryAlso: laparoscopic mesh fixation with Histoacryl Lapfix - CannulaIn 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, | Device | Histoacryl Lapfix |
Primary outcome
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.
18 secondary outcomes
Delayed tissue adhesive polymerization
Time frame: intraoperatively
Intraoperative bleeding requiring therapeutic measures
Time frame: intraoperatively
Organ injury
Time frame: intraoperatively
Hernia recurrence
Time frame: 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
Adhesions
Time frame: 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
Meshoma formation
Time frame: 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
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
Hematoma
Time frame: 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
Hemorrhage
Time frame: 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
Other Adverse Event
Time frame: 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
Mesh repositioning or removal
Time frame: until 6 months postoperatively
Acute or chronic pain
Time frame: until 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Aesculap AG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence rate (time frame: until 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.