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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00970515
First received: September 1, 2009
Last updated: October 27, 2011
Last verified: May 2011

September 1, 2009
October 27, 2011
November 2009
March 2012   (final data collection date for primary outcome measure)
  • Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00970515 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Postoperative fever > 38°5 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Postoperative ileus [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Postoperative phlebitis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Postoperative pulmonary embolism [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Postoperative urinary infection [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Duration of drainage [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Mesh infection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Peritonitis due to intraperitoneal mesh [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occlusion due to intra peritoneal mesh [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Recurrence of incisional or umbilical hernia [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Trocar site hernia [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Incisional Hernia
  • Umbilical Hernia
  • Procedure: Laparoscopic mesh hernia repair
    The mesh is intraperitoneal
    Other Name: laparoscpic mesh repair of incisional and umbilical hernia
  • 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
    Other Name: Conventional treatment of incisional and umbilical hernia
  • Experimental: Laparoscopic approach
    group A: Laparoscopic approach
    Intervention: Procedure: Laparoscopic mesh hernia repair
  • Active Comparator: Open approach
    group B: Open anterior approach
    Intervention: Procedure: Open anterior approach

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2014
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Corinne Vons, MD, PhD 01.48.02.67.03 corinne.vons@jvr.aphp.fr
France
 
NCT00970515
K060214, 2007-A00374-49
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Corinne Ms Vons, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP