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

Not Applicable

Completed

• Conditions: Chronic Pain; Seroma; Recurrence; Infections; Hernia, Inguinal; Hematoma

• Registration Number: NCT05929378
• Lead Sponsor: Nanchong Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-06-17
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-07-03
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
recurrence	6 months	Check for recurrence by clinical examination or ultrasound at 6 months postoperatively
Postoperative pain	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 Outcome Measures

Name	Time	Method
postoperative complications	6 months	Including infection, seroma, hematoma

Trial Locations

Locations (1)

Yunhong Tian; 🇨🇳 Nanchong, Sichuan, China