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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970515
First Posted: September 2, 2009
Last Update Posted: October 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Incisional Hernia Umbilical Hernia Procedure: Laparoscopic mesh hernia repair Procedure: Open anterior approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: November 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic approach
group A: Laparoscopic approach
Procedure: Laparoscopic mesh hernia repair
The mesh is intraperitoneal
Other Name: laparoscpic mesh repair of incisional and umbilical hernia
Active Comparator: Open approach
group B: Open anterior approach
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970515


Contacts
Contact: Corinne Vons, MD, PhD 01.48.02.67.03 corinne.vons@jvr.aphp.fr

Locations
France
Hôpital Jean Verdier, department of digestive and general surgery Recruiting
Bondy, France, 93140
Contact: Corinne Vons, MD, PhD    01.48.02.67.03    corinne.vons@jvr.aphp.fr   
Principal Investigator: Corinne Vons, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Corinne Ms Vons, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00970515     History of Changes
Other Study ID Numbers: K060214
2007-A00374-49 ( Other Identifier: IDRCB )
First Submitted: September 1, 2009
First Posted: September 2, 2009
Last Update Posted: October 28, 2011
Last Verified: May 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Laparoscopy
Incisional hernia
Umbilical hernia
Mesh repair
Postoperative complications

Additional relevant MeSH terms:
Hernia
Incisional Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal