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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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