Transabdominal Preperitoneal Inguinal Hernia Repair

N/AActive Not RecruitingNCT05839587

University of Southern Denmark150 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Hernia, Inguinal Laparoscopy

Interventions

Robotic TAPPPROCEDURE

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 TAPPPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sygehus Soenderjylland

Aabenraa, Denmark

Outcomes

Primary Outcomes

Surgical stress response (CRP)

Change of serum CRP over time.

Time frame: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively

Secondary Outcomes

Estimated intraoperative blood loss

The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon

Time frame: intraoperative (From first incision until last suture has been placed)

Intraoperative need of blood transfusion

The amount of blood transfused during surgery measured in mL

Time frame: intraoperative (From first incision until last suture has been placed)

Length of hospital stay

The number of days patients spend in the hospital following the procedure.

Time frame: Up to 3 months

Hernia defect size

The area of the hernial defect in cm2 measured at 8 mmHg

Time frame: During surgery

Total surgical time

The procedure will be divided into 4 parts. Part 1 will be different for the 2 procedures. In rTAPP it will consist of docking of the robot and port placement while it only will consist of port placement in TAPP. 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 4 will also be different for the 2 procedures. In rTAPP it will consist of de-docking and skin closure while it only will consist of skin closure in TAPP. Total surgical time and each part will be measured individually in minutes and the 2 procedures will be compared

Data from ClinicalTrials.gov

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