Hernia, Inguinal, Laparoscopy
Conditions
Keywords
Adult, Robotic surgical procedures, Abdomen
Brief 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
Detailed 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.
Interventions
PROCEDURELaparoscopic 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.
PROCEDURERobotic 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
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical stress response (CRP) | CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively | Change of serum CRP over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated intraoperative blood loss | intraoperative (From first incision until last suture has been placed) | The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon |
| Intraoperative need of blood transfusion | intraoperative (From first incision until last suture has been placed) | The amount of blood transfused during surgery measured in mL |
| Length of hospital stay | Up to 3 months | The number of days patients spend in the hospital following the procedure. |
| Hernia defect size | During surgery | The area of the hernial defect in cm2 measured at 8 mmHg |
| Total surgical time | During surgery | 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 |
| Postoperative complications | From surgery until 6 months postoperatively | Classified into grades (I-V) according to the Clavien-Dindo classification |
| Life-quality | From inclusion until 6 months postoperatively | 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) |
| Sexual dysfunction | From inclusion until 6 months postoperatively | 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 |
| Surgical stress response (IL1-β) | IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | The change of serum IL1-β over time. |
| Surgical stress response (IL-6) | IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | The change of serum IL-6 over time. |
| Surgical stress response (IL-8) | IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | The change of serum IL-8 over time. |
| Surgical stress response (IL-10) | IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | The change of serum IL-10 over time. |
| Surgical stress response (TNF-α) | TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation | The change of serum TNF-α over time. |
Countries
Denmark
Outcome results
None listed