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

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Laparoscopic transabdominal preperitoneal hernia repair.; Procedure: Lichtenstein hernia repair.

• Registration Number: NCT06240858
• Lead Sponsor: Second Hospital of Jilin University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAPP group	Laparoscopic transabdominal preperitoneal hernia repair.	The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair.
Lichtenstein group	Lichtenstein hernia repair.	The Lichtenstein group underwent Lichtenstein hernia repair.

Primary Outcome Measures

Name	Time	Method
Incidence of moderate to severe pain at 3 and 6 months after surgery.	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 Outcome Measures

Name	Time	Method
Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.	3 and 6 months after surgery.	Recurrence of inguinal hernia after surgery

Trial Locations

Locations (1)

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China