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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

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.

Condition or disease Intervention/treatment Phase
Incisional Hernia Umbilical Hernia Procedure: Laparoscopic mesh hernia repair Procedure: Open anterior approach Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Study Start Date : November 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. 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 ]
  2. Postoperative fever > 38°5 [ Time Frame: 2 months ]
  3. Postoperative ileus [ Time Frame: 2 months ]
  4. Postoperative phlebitis [ Time Frame: 2 months ]
  5. Postoperative pulmonary embolism [ Time Frame: 2 months ]
  6. Postoperative urinary infection [ Time Frame: 2 months ]
  7. Duration of hospital stay [ Time Frame: 2 months ]
  8. Duration of drainage [ Time Frame: 2 months ]
  9. Mesh infection [ Time Frame: 24 months ]
  10. Peritonitis due to intraperitoneal mesh [ Time Frame: 24 months ]
  11. Occlusion due to intra peritoneal mesh [ Time Frame: 2 months ]
  12. Recurrence of incisional or umbilical hernia [ Time Frame: 24 months ]
  13. Trocar site hernia [ Time Frame: 24 months ]


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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

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

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 Posted: September 2, 2009    Key Record Dates
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