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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05929378
Other study ID # 2023031
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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