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OpenTrials
Completed

NCT Number: NCT01669837

An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias

Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.

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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

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is older than 18 years.
  • Written informed consent is obtained from patient.
  • Patient is able to complete the EQ-5D questionnaire.
  • Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).

Exclusion criteria

  • Patient has a recurrent inguinal hernia.
  • Patient is treated using the Lichtenstein technique.
  • Mesh fixation with sutures, tacks, absorbable tacks or clips.
  • Patient is allergic to components of surgical tissue glue (Ifbond™).
  • Patient has a life expectancy of less than 1 year.

Treatment and study plan

Mesh fixation with surgical tissue glue

Device

Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

Primary outcomes

  1. Postoperative pain

    Time frame: up to 1 year

    Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.

Secondary outcomes

  1. Intraoperative complications

    Time frame: 1 day

    Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.

  2. Postoperative complications

    Time frame: Up to 30 days after index-procedure

    Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.

  3. Analgesic intake

    Time frame: Discharge, 5 weeks

    Intake of analgesics.

  4. Quality of life (QOL)

    Time frame: Preoperative, 5 weeks, 1 year

    QOL assessed by EQ-5D questionnaire.

  5. Freedom from hernia-related reinterventions

    Time frame: 1 year

    Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.

  6. Late complications

    Time frame: 1 year

    Local numbness, groin discomfort, hernia recurrence, sexual dysfunction

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Official study title

Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2012
Registry last updated
Jun 18, 2020

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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