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

Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Laparoscopic transabdominal preperitoneal hernia repair.; Procedure: Lichtenstein hernia repair.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130022
      • The Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAPP group; The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair.	Procedure: Laparoscopic transabdominal preperitoneal hernia repair.; The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.
Experimental: Lichtenstein group; The Lichtenstein group underwent Lichtenstein hernia repair.	Procedure: Lichtenstein hernia repair.; The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.	Recurrence of inguinal hernia after surgery	3 and 6 months after surgery.

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Herniorrhaphy; Laparoscopy; Self-gripping mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: (2022) Annual Audit No. (175)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing with other researchers is not planned at this time due to patient privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No