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Completed

NCT Number: NCT06298500

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital San Juan de Dios

Santa Cruz de Tenerife, Tenerife, 38001, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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,

Other names: laparoscopic mesh fixation with Histoacryl Lapfix - Cannula

Primary outcomes

  1. 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.

Secondary outcomes

  1. Delayed tissue adhesive polymerization

    Time frame: intraoperatively

    The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected.

  2. Intraoperative bleeding requiring therapeutic measures

    Time frame: intraoperatively

    Bleeding that requires additional measures than normal practice for stopping the hemorrhage.

  3. Organ injury

    Time frame: intraoperatively

    Cumulative Number of patients suffering from Injury of an organ adjacent to the defect.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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)

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. Reintervention

    Time frame: until 6 months postoperatively

    Patient requiring to be operated again for any reason.

  17. Mesh repositioning or removal

    Time frame: until 6 months postoperatively

    Patient requiring being operated again for repositioning or removal of the Mesh

  18. Acute or chronic pain

    Time frame: until 6 months postoperatively

    pain persisting beyond 6 months postoperatively re-quiring analgesic treatment

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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

Acronym: HISTOLAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Aug 20, 2025

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.

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