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A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh

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. Identifier: NCT00240188
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : September 16, 2010
Information provided by:
VA Office of Research and Development

Brief Summary:
The purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work.

Condition or disease Intervention/treatment Phase
Hernia, Ventral Procedure: Open mesh repair of ventral incisional hernia Procedure: Laparoscopic mesh repair of ventral incisional hernia Not Applicable

Detailed Description:

The appearance of ventral incisional hernia (VIH) following an open abdominal operation is an important postoperative problem. While advances in anesthesia techniques, better methods to prevent surgical infections, and improved treatment of infection, and the use of new suture materials have reduced the incidence of incisional hernias, incisional hernias still occurs in 0.5-11% of all open abdominal surgical procedures performed.

Overview of study design: We are conducting a 4 center randomized clinical trial to compare the outcomes of two methods of surgical management of ventral incisional hernia. Patients presenting to a physician with a ventral incisional hernia will be considered for the trial. The study is designed to compare the rate of complications, pain, time to return to normal activities, Health related quality of life (HRQoL) and patient satisfaction between laparoscopic and open mesh repair for ventral incisional hernia. The rate of recurrence of the hernia at 1-2 years will be evaluated as a secondary outcome. Four VA medical centers with the capability of enrolling 40-50 patients a year have been selected based on volume, experience with open and laparoscopic ventral herniorrhaphy and experience in the conduct of clinical trials. Patients are recruited by physicians at each site and referred to the site coordinator who screens them for eligibility. The trial is randomized but not blinded. The randomization scheme takes into consideration that random allocation of patients to each study group is made within each center. In addition to the participating center, the other baseline variables that serve as stratification factors are first time or recurrent ventral incisional hernia and patient with a body mass index greater or less than 35arm.

Timeline: The trial consists of 3 phases: Implementation, Patient intake and follow-up, closeout and final analysis. 1-Implementation (2 months): The implementation which will include funding, recruitment of the nurse coordinators and review of the study protocol and techniques of operation was 2 months in duration. 2-Patient intake and follow up (32 months): All study patients are recruited during that period of time. Follow-up will occur simultaneously and will end at close out. The range of follow-up is expected to range from 8 weeks to 34 months. 4-Final analysis and closeout: The participating centers will be given 2 months of funding to close out the data collection. During this period, all final follow-up visits and data collection will be completed. Final analysis will run concurrently with closeout.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ventral Incisional Hernia Repair: Comparison Of Laparoscopic and Open Repair With Mesh
Study Start Date : February 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
1 Procedure: Open mesh repair of ventral incisional hernia
For the open procedure, the technique, as described by Chevrel and others was adopted.

Procedure: Laparoscopic mesh repair of ventral incisional hernia
For the laparoscopic repair, the method of Gagner was adopted

Primary Outcome Measures :
  1. Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type [ Time Frame: Eight (8) weeks post-operatively ]

Secondary Outcome Measures :
  1. Compare pain, return to normal activities of daily living, and return to work. Health related quality of life, and recurrence. [ Time Frame: One (1) and two (2) years post-operatively ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients will be eligible for enrollment into the study if they meet the following criteria: -Are 18 years of age or older -Have a diagnosis of ventral primary incisional hernia 9-225 cm2 in size. -Give informed consent for randomization - Have a negative pregnancy test. (Women)

Exclusion Criteria:

Patients will be excluded for the following reasons: -Hernia cannot be detected on physical examination - Primary ventral or umbilical hernia - Small hernia defined as less than 9 cm2 - Giant hernia defined as greater than 225 cm2 in size - ASA class 4 or 5, or contraindications to general anesthesia - Severe co morbid conditions likely to limit survival to less than 3 years - History of malignancy within the past 5 years except for non-melanoma skin cancer - Cirrhosis with or without ascites - Presence of bowel obstruction( partial or intermittent), strangulation, peritonitis, or perforation. - Presence of local or systemic infection - Participation in another clinical trial - Emergency operation - Prisoner

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 identifier (NCT number): NCT00240188

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United States, Massachusetts
VA Boston Healthcare System, Boston
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Kamal Itani, MD VA Boston Healthcare System, Boston

Publications of Results:
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Responsible Party: Itani, Kamal - Principal Investigator, Department of Veterans Affairs Identifier: NCT00240188    
Other Study ID Numbers: CLIN-011-03S
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by VA Office of Research and Development:
Additional relevant MeSH terms:
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Incisional Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Hernia, Abdominal