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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314152
• Other study ID #: 2023032
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 10, 2024

Study information

• Verified date: March 2024
• Source: Nanchong Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 337
• Est. completion date: October 10, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hematoma
• Hernia
• Hernia, Inguinal
• Infections
• Inguinal Hernia
• Recurrent
• Seroma

Intervention

Procedure:
• Lightweight mesh fixation in 3 points or 1 point
Lightweight mesh fixation in 3 points

Locations

Country	Name	City	State
China	Yunhong Tian	Nanchong	Sichuan

Sponsors (7)

Lead Sponsor	Collaborator
Nanchong Central Hospital	Guang'an People's Hospital, Langzhong People's Hospital, Langzhong Traditional Chinese Medicine Hospital, Nanbu Hospital of County Chinese Medicine, Pengan County People's Hospital, People's Hospital of Yilong County

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence	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
Primary	Rate of postoperative pain	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.	6 months
Secondary	Rate of postoperative complications	Including infection, seroma, hematoma	6 months