Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

University of Southern Denmark (SDU)

Status: Active, not recruiting

Conditions: Laparoscopy; Hernia, Inguinal

Treatments: Procedure: Laparoscopic TAPP; Procedure: Robotic TAPP

Study type: Interventional

Funder types: Other

Identifiers

NCT05839587

SHS-MT Kir - 1 - 2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA 1- 3
• Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal)
• Eligible for a laparoscopic procedure
• Informed concent

Exclusion criteria

• Incarcerated inguinal hernia requiring emergency surgery
• Pregnancy
• Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of pain relieve (paracetamol, NSAID etc)
• Active cancer
• History of psychiatric or additive disorder that prevent the patient from participating in the trial
• Co-existing inflammatory disease
• Co-existing immunological disease that requires medication of any kind

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Robotic TAPP

Experimental group

Description:

Repair of primary unilateral and bilateral hernias with robotic technology

Treatment:

Procedure: Robotic TAPP

Laparoscopic TAPP

Active Comparator group

Description:

Repair of primary unilateral and bilateral hernias with laparoscopic repair

Treatment:

Procedure: Laparoscopic TAPP