Transabdominal Preperitoneal Inguinal Hernia Repair

Study Overview
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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

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.

Official Title
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Short-term Outcome and Inflammatory Stress Response Following Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - A Prospective, Randomized Trial Comparing Laparoscopy to the Robotic-assisted Approach

Conditions
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Hernia, Inguinal, Laparoscopy

Intervention / Treatment
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* Procedure: Robotic TAPP
* Procedure: Laparoscopic TAPP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic TAPP<br>Repair of primary unilateral and bilateral hernias with robotic technology | Procedure: Robotic TAPP<br>* 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<br>|
| Active Comparator: Laparoscopic TAPP<br>Repair of primary unilateral and bilateral hernias with laparoscopic repair | Procedure: Laparoscopic TAPP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical stress response (CRP) | Change of serum CRP over time. | CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated intraoperative blood loss | The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon | 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 | 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. | Up to 3 months | 
| Hernia defect size | The area of the hernial defect in cm2 measured at 8 mmHg | 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 | During surgery | 
| Postoperative complications | Classified into grades (I-V) according to the Clavien-Dindo classification | From surgery until 6 months postoperatively | 
| Life-quality | According to the EUropean Registry for Abdominal wall HerniaS Quality Of Life questionnaire (Eura-HS QoL). The total score ranges from 0 (best quality of life) to 90 (worst quality of life) | From inclusion until 6 months postoperatively | 
| Sexual dysfunction | According to the Sexual Inguinal Hernia Questionnaire (SexIHQ) a 1-page, 8-question questionnaire including visual analogue scales and tick-boxes used to asses sexual dysfunction following inguinal hernia repair | From inclusion until 6 months postoperatively | 
| Surgical stress response (IL1-β) | The change of serum IL1-β over time. | IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | 
| Surgical stress response (IL-6) | The change of serum IL-6 over time. | IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | 
| Surgical stress response (IL-8) | The change of serum IL-8 over time. | IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | 
| Surgical stress response (IL-10) | The change of serum IL-10 over time. | IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | 
| Surgical stress response (TNF-α) | The change of serum TNF-α over time. | TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, Robotic surgical procedures, Abdomen