Transabdominal Preperitoneal Inguinal Hernia Repair

Last updated: February 13, 2025
Sponsor: University of Southern Denmark
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hernia

Treatment

Robotic TAPP

Laparoscopic TAPP

Clinical Study ID

NCT05839587
SHS-MT Kir - 1 - 2023
  • Ages > 18
  • All Genders

Study Summary

The present study seeks to determine whether improved visual acuity and enhanced flexibility of the robotic platform results in a reduced surgical stress response and an improvement in indices of surgical outcome measures for simple and complex inguinal hernia repair

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA 1- 3

  • Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral,recurrent, inguinoscrotal)

  • Eligible for a laparoscopic procedure

  • Informed concent

Exclusion

Exclusion Criteria:

  • Incarcerated inguinal hernia requiring emergency surgery

  • Pregnancy

  • Patients with chronic pain due to arthritis, migraine or other illness requiringregular intake of pain relieve (paracetamol, NSAID etc)

  • Active cancer

  • History of psychiatric or additive disorder that prevent the patient fromparticipating in the trial

  • Co-existing inflammatory disease

  • Co-existing immunological disease that requires medication of any kind

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Robotic TAPP
Phase:
Study Start date:
November 11, 2022
Estimated Completion Date:
May 31, 2025

Study Description

Complex inguinal hernia repair is challenging and requires both advanced skills in laparoscopic surgery and knowledge about the complex anatomy of the inguinal area. Whereas the repair of a small inguinal hernia usually is simple and straightforward, complex hernias (large inguinoscrotal and recurrent hernias) constitute a surgical challenge due to the risk of damage of the neurovascular structures in the inguinal area. It requires advanced laparoscopic skills to reduce the hernial sac in patients with large lateral hernias, where the hernial sac often extends deep into the scrotum in close vicinity to the spermatic cord and the testicular artery. This dissection is difficult with conventional laparoscopy, which may explain the risk of chronic pain, testicular hypotrophy and hernia recurrence. The aim of the study is to determine whether rTAPP of complex inguinal hernias is associated with a lower surgical stress response and a lower risk of postoperative complications compared to laparoscopic TAPP.

Connect with a study center

  • Sygehus Soenderjylland

    Aabenraa, 6200
    Denmark

    Site Not Available

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