Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Study Overview
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Brief Summary
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Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.

Detailed Description
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Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity. To perform a prospective randomized trial comparing pain after inguinal hernia repair using either fixation with stapler or histoacryl. The standard TAPP procedure is performed under general anesthesia. Patients receive a single shot antibiotic prophylaxis, using Amoxicillin/Clavulanic Acids. Operations are performed by resident surgeons under supervision, consultants or senior consultants. After hernial sac dissection and retraction, preperitoneal fat is removed bluntly and Cooper's ligament is identified. A Vypro II ® (Ethicon ®) prosthetic mesh, 10x15 cm, is placed and fixed depending on randomization with either 5 mm Protack TM (Autosuture TM) or Glubran ® 2 (G.E.M., Viareggio, Italy). Randomization is performed in permutated block of 20 using sealed envelopes. Where tissue glue is used, meshs are additionally fixed caudally and laterocaudally. Peritoneal closure over the mesh is performed using resorptive sutures. Glubran ® 2 is a cyanoacrylate tissue adhesive. Follow up assessment: The use of analgesics in the postoperative period is standardized using paracetamol and morphine derivates. Following discharge patients are liberated of physical restrictions. Patient follow-up will be performed after 6 weeks, 6 and 12 months postoperatively. Patients are advised to mention pain in the operated groin area. In addition the Visual Analogue Scale is used to evaluate pain intensity.Statistical comparison is done using Mann-Whitney Test and Chi square Test (significance p < 0,05).

Official Title
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Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Conditions
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Inguinal Hernia, Recurrence, Pain

Intervention / Treatment
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* Procedure: Mesh fixation by staples
* Procedure: Mesh fixation by glue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for laparoscopic primary inguinal hernia repair uni- or bilateral patients with recurrent hernias after anterior surgical technique written informed consent Exclusion Criteria: general contradictions for laparoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Mesh fixation by staples | Procedure: Mesh fixation by staples<br>* Mesh fixation by staples<br>|
| Other: B<br>Mesh fixation by glue | Procedure: Mesh fixation by glue<br>* Mesh fixation by glue<br>* Other names: N-Butyl-2 Cyanoacrulat Glue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence |  | 6 weeks, 6 months, 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 6 weeks, 6 months, 12 months postoperative | 
| sensibility disorder |  | 6 weeks, 6 months, 12 months postoperative | 
| intra- and postoperative complications |  | 6 weeks, 6 months, 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, laparoscopy, mesh