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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: Lightweight mesh fixation


Participation Criteria
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Eligibility Criteria
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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: Female patients 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-point fixation group<br>Lightweight Mesh Fixation with 3-point Fixation. First fixation is in cooper ligament. Second fixation is in the back of rectus abdominis. Third fixation is in the later of tractus iliopubicus. | Procedure: Lightweight mesh fixation<br>* Lightweight mesh fixation in 3 points<br>|
| Active Comparator: 1-point fixation group<br>Lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis. | Procedure: Lightweight mesh fixation<br>* Lightweight mesh fixation in 3 points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | Check for recurrence by clinical examination or ultrasound at 6 months postoperatively | 6 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | Including infection, seroma, hematoma | 6 months |