Transabdominal Preperitoneal Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2025-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hernia, Inguinal Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic TAPP

Repair of primary unilateral and bilateral hernias with robotic technology

Group Type EXPERIMENTAL

Robotic TAPP

Intervention Type PROCEDURE

Robotic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of docking of the robot and port placement and part 4 consists of de-docking and skin closure

Laparoscopic TAPP

Repair of primary unilateral and bilateral hernias with laparoscopic repair

Group Type ACTIVE_COMPARATOR

Laparoscopic TAPP

Intervention Type PROCEDURE

Laparoscopic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of port placement only and part 4 consists of skin closure only.

Interventions

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Robotic TAPP

Robotic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of docking of the robot and port placement and part 4 consists of de-docking and skin closure

Intervention Type PROCEDURE

Laparoscopic TAPP

Laparoscopic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of port placement only and part 4 consists of skin closure only.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No