Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia (EVENTRALAP)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Umbilical Hernia; Incisional Hernia

Treatments: Procedure: Laparoscopic mesh hernia repair; Procedure: Open anterior approach

Study type: Interventional

Funder types: Other

Identifiers

NCT00970515

K060214

2007-A00374-49 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Laparoscopic approach

Experimental group

Description:

group A: Laparoscopic approach

Treatment:

Procedure: Laparoscopic mesh hernia repair

Open approach

Active Comparator group

Description:

group B: Open anterior approach

Treatment:

Procedure: Open anterior approach