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Completed

NCT Number: NCT05839587

Transabdominal Preperitoneal Inguinal Hernia Repair

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

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Laparoscopy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Surgical stress response (CRP)

    Time frame: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively

    Change of serum CRP over time.

Secondary outcomes

  1. Estimated intraoperative blood loss

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

    The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon

  2. Intraoperative need of blood transfusion

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

    The amount of blood transfused during surgery measured in mL

  3. Length of hospital stay

    Time frame: Up to 3 months

    The number of days patients spend in the hospital following the procedure.

  4. Hernia defect size

    Time frame: During surgery

    The area of the hernial defect in cm2 measured at 8 mmHg

  5. Total surgical time

    Time frame: 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

  6. Postoperative complications

    Time frame: From surgery until 6 months postoperatively

    Classified into grades (I-V) according to the Clavien-Dindo classification

  7. Life-quality

    Time frame: 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)

  8. Sexual dysfunction

    Time frame: 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

  9. Surgical stress response (IL1-β)

    Time frame: 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.

  10. Surgical stress response (IL-6)

    Time frame: 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.

  11. Surgical stress response (IL-8)

    Time frame: 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.

  12. Surgical stress response (IL-10)

    Time frame: 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.

  13. Surgical stress response (TNF-α)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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

Acronym: TAPP

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 3, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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