Status:
TERMINATED
Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Incisional Hernia
Umbilical Hernia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- Age \> 18
- Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00970515
Start Date
November 1 2009
End Date
April 1 2013
Last Update
June 18 2021
Active Locations (1)
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1
Hôpital Jean Verdier, department of digestive and general surgery
Bondy, France, 93140