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
Verified date | December 2023 |
Source | Nanchong Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Yunhong Tian | Nanchong | Sichuan |
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 |
China,
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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