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

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ClinicalTrials.gov Identifier: NCT00970515
Recruitment Status : Unknown
Verified May 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 2, 2009
Last Update Posted : October 28, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 1, 2009
First Posted Date  ICMJE September 2, 2009
Last Update Posted Date October 28, 2011
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Incisional Hernia
  • Umbilical Hernia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 1, 2009)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00970515
Other Study ID Numbers  ICMJE K060214
2007-A00374-49 ( Other Identifier: IDRCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corinne Ms Vons, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2011

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