Status:
COMPLETED
A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Hernia, Ventral
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 surgic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00240188
Start Date
February 1 2004
End Date
December 1 2006
Last Update
September 16 2010
Active Locations (1)
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1
VA Boston Healthcare System, Boston
Boston, Massachusetts, United States, 02130