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

Not Applicable

Completed

• Conditions: Recurrent; Hematoma; Chronic Pain; Infections; Seroma; Inguinal Hernia
• Interventions: Procedure: Lightweight mesh fixation in 3 points or 1 point

• Registration Number: NCT06314152
• 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 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: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-15
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

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

Inclusion Criteria

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

The inclusion criteria were as follows: primary indirect inguinal hernia.

Exclusion Criteria

• Age below 18 years or older than 80. recurrent hernia, incarcerated hernia, direct 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

Arm && Interventions

Group	Intervention	Description
3-point fixation group	Lightweight mesh fixation in 3 points or 1 point	During laparoscopic transabdominal preperitoneal inguinal hernia repair, lightweight Mesh Fixation with 3-point Fixation. First fixation is in cooper ligament. Second fixation is in the back of rectus abdominis. Third fixation is in the later of tractus iliopubicus.
1-point fixation group	Lightweight mesh fixation in 3 points or 1 point	During laparoscopic transabdominal preperitoneal inguinal hernia repair, lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis.

Primary Outcome Measures

Name	Time	Method
Rate of 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.
Rate of recurrence	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yunhong Tian; 🇨🇳 Nanchong, Sichuan, China