Chronic Pain Clinical Trial
Official title:
A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
Verified date | March 2024 |
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 inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.
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. |
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, Pengan County People's Hospital, People's Hospital of Yilong County |
China,
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 |
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