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

Chronic Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929378
• Other study ID #: 2023031
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: December 2023
• 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 type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 436
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Lightweight mesh fixation
Lightweight mesh fixation in 3 points

Locations

Country	Name	City	State
China	Yunhong Tian	Nanchong	Sichuan

Sponsors (8)

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, Nanchong Jialing District People's Hospital, 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	recurrence	Check for recurrence by clinical examination or ultrasound at 6 months postoperatively	6 months
Primary	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	postoperative complications	Including infection, seroma, hematoma	6 months