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

This study is currently recruiting participants.
Verified May 2011 by Assistance Publique - Hôpitaux de Paris
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 1, 2009
Last Updated: October 27, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
 Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 16, 2013