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NCT Number: NCT06240858

Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair

The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.

Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.

Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Jilin University

Changchun, Jilin, 130022, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male patients aged 18 years and older.
  • Patients with a definite diagnosis of unilateral primary inguinal hernia.
  • Patients and their families were informed about the study protocol and agreed to participate in the study.

Exclusion criteria

  • Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
  • Patients with previous history of lower abdominal surgery.
  • Patients with contraindications to anaesthesia.
  • Patients with contraindications to laparoscopic surgery.
  • Failure to follow up patients as scheduled.
  • Patients with abdominal infections.
  • Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.

Treatment and study plan

Laparoscopic transabdominal preperitoneal hernia repair.

Procedure

The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.

Lichtenstein hernia repair.

Procedure

The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.

Primary outcomes

  1. Incidence of moderate to severe pain at 3 and 6 months after surgery.

    Time frame: 3 and 6 months after surgery.

    Visual analogue scale (VAS) was used to score the postoperative pain at 3 and 6 months. The score ranges from 0 (no pain) to 10 (most severe pain).

Secondary outcomes

  1. Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.

    Time frame: 3 and 6 months after surgery.

    Recurrence of inguinal hernia after surgery

Sponsors and collaborators

Lead sponsor

Second Hospital of Jilin University

Other

Registry information

Official study title

Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2024
Registry last updated
Feb 6, 2024

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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