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

NCT06240858 | Completed

• 1 other identifier: (2022) Annual Audit No. (175)
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Self-gripping mesh; Laparoscopy; Herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3 and 6 months after surgery.

Study Arms (2)

TAPP group

EXPERIMENTAL

The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair.

Procedure: Laparoscopic transabdominal preperitoneal hernia repair.

Lichtenstein group

EXPERIMENTAL

The Lichtenstein group underwent Lichtenstein hernia repair.

Procedure: Lichtenstein hernia repair.

Interventions

Laparoscopic transabdominal preperitoneal hernia repair. PROCEDURE

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

TAPP group

Lichtenstein hernia repair. PROCEDURE

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

Lichtenstein group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients aged 18 years and older were selected.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Sites (1)

The Second Hospital of Jilin University

Changchun, Jilin, 130022, China

Location

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: January 26, 2024
• First Posted: February 5, 2024
• Study Start: March 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)