Clinical trial NCT05839587: Transabdominal Preperitoneal Inguinal Hernia Repair
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hernia, Inguinal
Laparoscopy
Keywords: Adult
Robotic surgical procedures
Abdomen
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical stress response (CRP)
timeFrame: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively
Secondary outcomes:
measure: Estimated intraoperative blood loss
timeFrame: intraoperative (From first incision until last suture has been placed)
measure: Intraoperative need of blood transfusion
timeFrame: intraoperative (From first incision until last suture has been placed)
measure: Length of hospital stay
timeFrame: Up to 3 months
measure: Hernia defect size
timeFrame: During surgery
measure: Total surgical time
timeFrame: During surgery
measure: Postoperative complications
timeFrame: From surgery until 6 months postoperatively
measure: Life-quality
timeFrame: From inclusion until 6 months postoperatively
measure: Sexual dysfunction
timeFrame: From inclusion until 6 months postoperatively
measure: Surgical stress response (IL1-β)
timeFrame: IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
measure: Surgical stress response (IL-6)
timeFrame: IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
measure: Surgical stress response (IL-8)
timeFrame: IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
measure: Surgical stress response (IL-10)
timeFrame: IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
measure: Surgical stress response (TNF-α)
timeFrame: TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Soenderjylland
Study officials:
References:
citation: McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.
citation: Podolsky D, Novitsky Y. Robotic Inguinal Hernia Repair. Surg Clin North Am. 2020 Apr;100(2):409-415. doi: 10.1016/j.suc.2019.12.010. Epub 2020 Feb 1.
citation: Huerta S, Timmerman C, Argo M, Favela J, Pham T, Kukreja S, Yan J, Zhu H. Open, Laparoscopic, and Robotic Inguinal Hernia Repair: Outcomes and Predictors of Complications. J Surg Res. 2019 Sep;241:119-127. doi: 10.1016/j.jss.2019.03.046. Epub 2019 Apr 22.