NCT00970515

Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Incisional Hernia
• Umbilical Hernia

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic mesh hernia repair	The mesh is intraperitoneal
PROCEDURE	Open anterior approach	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

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-04-01
• Completion: 2013-04-01
• First posted: 2009-09-02
• Last updated: 2021-06-18

Locations

1 site across 1 country: France