Clinical Trial: Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 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.

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome:

  • Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis [ Time Frame: 2 months ]
  • Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage [ Time Frame: 2 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 2 months ]
  • Postoperative fever > 38°5 [ Time Frame: 2 months ]
  • Postoperative ileus [ Time Frame: 2 months ]
  • Postoperative phlebitis [ Time Frame: 2 months ]
  • Postoperative pulmonary embolism [ Time Frame: 2 months ]
  • Postoperative urinary infection [ Time Frame: 2 months ]
  • Duration of hospital stay [ Time Frame: 2 months ]
  • Duration of drainage [ Time Frame: 2 months ]
  • Mesh infection [ Time Frame: 24 months ]
  • Peritonitis due to intraperitoneal mesh [ Time Frame: 24 months ]
  • Occlusion due to intra peritoneal mesh [ Time Frame: 2 months ]
  • Recurrence of incisional or umbilical hernia [ Time Frame: 24 months ]
  • Trocar site hernia [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 1, 2009
Date Started: November 2009
Date Completion: March 2014
Last Updated: October 27, 2011
Last Verified: May 2011