Inguinal Hernia
Conditions
Brief summary
This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.
Detailed description
consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.
Interventions
PROCEDURETack fixation of mesh
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) or spiral titanium tacks (active comparator) according to the result of randomization
PROCEDURESynthetic glue fixation
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients present with clinical bilateral inguinal hernias And feasible for general anesthesia
Exclusion criteria
* Patient preference for either fixation technique, refusal to participate, previous major lower abdominal surgery, concomitant surgical procedures other than hernia repair, and history of allergy to Histoacryl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| acute post-operative pain with VAS | 6 hours after OP |
Secondary
| Measure | Time frame |
|---|---|
| Chronic pain VAS pain scale | 6 months after OP |
| Questionnaire of complications | 6 months after OP |
Countries
Taiwan
Outcome results
None listed