3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia

April 6, 2026 updated by: Nanchong Central Hospital

A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia

This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Yunhong Tian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Unilateral inguinal hernia according to preoperative physical examination and imaging examination.

The inclusion criteria were as follows: primary inguinal hernia.

Exclusion Criteria:

  • Age below 18 years or older than 80. recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias.

Patients not suitable for general anesthesia. Patients requiring open surgery; patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3-point fixation group
Using 3-0 absorbable sutures, the mesh was secured at three key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, and (3) the lateral edge of the iliopubic tract.
Procedure: Lightweight mesh fixation in 3 points or 1 point
Lightweight mesh fixation in 3 points
Active Comparator: 1-point fixation group
Using 3-0 absorbable sutures, the mesh was secured at one of the following key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, or (3) the lateral edge of the iliopubic tract. The fixation site was selected based on the most prominent anatomical landmark, with preference given to the pubic pectineal ligament (Cooper's ligament) or the lateral edge of the iliopubic tract.
Procedure: Lightweight mesh fixation in 3 points or 1 point
Lightweight mesh fixation in 3 points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrence
Time Frame: 1 month,3 months,6 months and 12 months after surgery
Hernia recurrenceFollow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.
1 month,3 months,6 months and 12 months after surgery
Rate of postoperative pain
Time Frame: 12 months
The visual analog scale (VAS) was adopted for pain evaluation 1 day, 7 days, 1 month, 3 months, 6 months and 12 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative complications
Time Frame: 12 months
Including infection, seroma, hematoma
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanchong Central Hospital

Collaborators

Guang'an People's Hospital
Pengan County People's Hospital
People's Hospital of Yilong County
Nanbu Hospital of County Chinese Medicine
Langzhong People's Hospital
Langzhong Traditional Chinese Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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