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NCT Number: NCT05929378

A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III 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 type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.

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Key information

Conditions

Hernia, Inguinal Chronic Pain Disease Attributes Hematoma Hemorrhage Hernia Hernia, Abdominal Infections Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence Seroma Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunhong Tian

Nanchong, Sichuan, 637000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)

Exclusion criteria

Age below 18 years or older than 80. Direct hernia, femoral hernia, 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.

Treatment and study plan

Lightweight mesh fixation

Procedure

Lightweight mesh fixation in 3 points

Primary outcomes

  1. recurrence

    Time frame: 6 months

    Check for recurrence by clinical examination or ultrasound at 6 months postoperatively

  2. Postoperative pain

    Time frame: 6 months

    The visual analog scale (VAS) was adopted for pain evaluation 2 days, 3 months, and 6 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.

Secondary outcomes

  1. postoperative complications

    Time frame: 6 months

    Including infection, seroma, hematoma

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Collaborators

  • Guang'an People's Hospital
  • Langzhong People's Hospital
  • Langzhong Traditional Chinese Medicine Hospital
  • Nanbu Hospital of County Chinese Medicine
  • Nanchong Jialing District People's Hospital
  • Pengan County People's Hospital
  • People's Hospital of Yilong County

Registry information

Official study title

A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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