Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Not Applicable

Completed

• Conditions: Inguinal Hernia; Recurrence; Pain
• Interventions: Procedure: Mesh fixation by glue; Procedure: Mesh fixation by staples

• Registration Number: NCT00793286
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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

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).

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Last Update Submitted: 2008-11-21
• Last Update Posted: 2008-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Mesh fixation by glue	Mesh fixation by glue
A	Mesh fixation by staples	Mesh fixation by staples

Primary Outcome Measures

Name	Time	Method
Recurrence	6 weeks, 6 months, 12 months postoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dep. of Visceral and Transplantsurgery, Bern University Hospital; 🇨🇭 Bern, Switzerland