Transabdominal Preperitoneal Inguinal Hernia Repair

Laparoscopy Clinical Trial

— TAPP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839587
• Other study ID #: SHS-MT Kir - 1 - 2023
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2023
• Source: University of Southern Denmark
• Contact: Alexandros Nikolaou Valsamidis
• Phone: 0045 79973539
• Email: alexandros.nikolaou.valsamidis[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Laparoscopy

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
Denmark	Sygehus Soenderjylland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Length of hospital stay	The number of days patients spend in the hospital following the procedure.	Up to 3 months
Secondary	Hernia defect size	The area of the hernial defect in cm2 measured at 8 mmHg	During surgery
Secondary	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
Secondary	Postoperative complications	Classified into grades (I-V) according to the Clavien-Dindo classification	From surgery until 6 months postoperatively
Secondary	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
Secondary	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
Secondary	Surgical stress response (IL1-ß)	The change of serum IL1-ß over time.	IL1-ß will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Secondary	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
Secondary	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
Secondary	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
Secondary	Surgical stress response (TNF-a)	The change of serum TNF-a over time.	TNF-a will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation