Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

Study Overview
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Brief Summary
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The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.

Detailed Description
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The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia. Five hundred patients will be included in this randomized, multicentric trial. Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.

Official Title
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A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia

Conditions
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Incisional Hernia, Umbilical Hernia

Intervention / Treatment
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* Procedure: Laparoscopic mesh hernia repair
* Procedure: Open anterior approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter Exclusion Criteria: Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication Patients with a recurrence of incisional hernia Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible Pregnant women Patients with HIV therapy Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin> 35 micromol / l; TP < 55%) or significant thrombocytopenia (< 60 000 platelets) Patients with a contra indication for laparoscopy Patients with a life expectancy < one year, or whose mobility within two years of treatment will damage proper monitoring Patients unable to understand information about the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic approach<br>group A: Laparoscopic approach | Procedure: Laparoscopic mesh hernia repair<br>* The mesh is intraperitoneal<br>* Other names: laparoscpic mesh repair of incisional and umbilical hernia;|
| Active Comparator: Open approach<br>group B: Open anterior approach | Procedure: Open anterior approach<br>* The mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal<br>* Other names: Conventional treatment of incisional and umbilical hernia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis |  | 2 months | 
| Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use |  | 2 months | 
| Postoperative fever > 38°5 |  | 2 months | 
| Postoperative ileus |  | 2 months | 
| Postoperative phlebitis |  | 2 months | 
| Postoperative pulmonary embolism |  | 2 months | 
| Postoperative urinary infection |  | 2 months | 
| Duration of hospital stay |  | 2 months | 
| Duration of drainage |  | 2 months | 
| Mesh infection |  | 24 months | 
| Peritonitis due to intraperitoneal mesh |  | 24 months | 
| Occlusion due to intra peritoneal mesh |  | 2 months | 
| Recurrence of incisional or umbilical hernia |  | 24 months | 
| Trocar site hernia |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Incisional hernia, Mesh repair, Postoperative complications, Umbilical hernia