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

Completed · Not applicable

Conditions studied: Hernia, Ventral

In brief

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.

Key facts

Study ID

NCT00240188

Run by

US Department of Veterans Affairs

People needed

110

Starts

2004-02-01

Expected to finish

2006-12-01

Last updated by the study team

2010-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• VA Boston Healthcare System, Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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