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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240858
• Other study ID #: (2022) Annual Audit No. (175)
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2024
• Source: Second Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Laparoscopic transabdominal preperitoneal hernia repair.
The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.
• Lichtenstein hernia repair.
The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of moderate to severe pain at 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).	3 and 6 months after surgery.
Secondary	Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.	Recurrence of inguinal hernia after surgery	3 and 6 months after surgery.