Transabdominal Preperitoneal Inguinal Hernia Repair

NCT05839587 | Active Not Recruiting

• 1 other identifier: SHS-MT Kir - 1 - 2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Hernia, Inguinal; Laparoscopy

Keywords

Adult; Robotic surgical procedures; Abdomen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Estimated intraoperative blood loss

  intraoperative (From first incision until last suture has been placed)

• Intraoperative need of blood transfusion

  intraoperative (From first incision until last suture has been placed)

• Length of hospital stay

  Up to 3 months

• Hernia defect size

  During surgery

• Total surgical time

  During surgery

Study Arms (2)

Robotic TAPP

EXPERIMENTAL

Repair of primary unilateral and bilateral hernias with robotic technology

Procedure: Robotic TAPP

Laparoscopic TAPP

ACTIVE COMPARATOR

Repair of primary unilateral and bilateral hernias with laparoscopic repair

Procedure: Laparoscopic TAPP

Interventions

Robotic TAPP PROCEDURE

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

Robotic TAPP

Laparoscopic TAPP PROCEDURE

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.

Laparoscopic TAPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1- 3
• Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal)
• Eligible for a laparoscopic procedure
• Informed concent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (5)

• 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.

  PMID: 12535413 BACKGROUND

• 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.

  PMID: 32169186 BACKGROUND

• 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.

  PMID: 31022677 BACKGROUND

• 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.

  PMID: 40277023 DERIVED

• 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.

  PMID: 39118135 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: May 3, 2023
• Study Start: November 11, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)