A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh
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|ClinicalTrials.gov Identifier: NCT00240188|
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : September 16, 2010
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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 ]
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): NCT00240188
|United States, Massachusetts|
|VA Boston Healthcare System, Boston|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Kamal Itani, MD||VA Boston Healthcare System, Boston|