Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

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

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

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal; Laparoscopy
• Intervention / Treatment: Procedure: Robotic TAPP; Procedure: Laparoscopic TAPP

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Sygehus Soenderjylland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic TAPP; Repair of primary unilateral and bilateral hernias with robotic technology	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
Active Comparator: Laparoscopic TAPP; Repair of primary unilateral and bilateral hernias with laparoscopic repair	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Valorenzos A, Nielsen KA, Kaiser K, Petersen SR, Helligso P, Dorfelt A, Lambertsen KL, Ellebaek MB, Nielsen MF. Inflammatory response and short-term outcomes after laparoscopic versus robotic transabdominal preperitoneal inguinal hernia repair: randomized clinical trial (ROLAIS). Br J Surg. 2025 Mar 28;112(4):znaf074. doi: 10.1093/bjs/znaf074.
• Valorenzos AV, Nielsen KA, Kaiser K, Helligso P, Ellebaek MB, Dorfelt A, Petersen SR, Pedersen AK, Nielsen MF. Short-term outcomes and inflammatory stress response following laparoscopy or robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP): study protocol for a prospective, randomized trial (ROLAIS). Trials. 2024 Aug 8;25(1):529. doi: 10.1186/s13063-024-08361-w.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adult; Abdomen; Robotic surgical procedures
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal
• Other Study ID Numbers: SHS-MT Kir - 1 - 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No