Incisional Hernia Outcomes Study Using Parietex Composite Mesh
The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh|
- Visual analog (VAS) scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]pain assessment
|Study Start Date:||August 2004|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Laparoscopic incisional hernia repair
Subjects with an incisional, ventral, umbilical, or spigelian hernia no larger tham 15 cm at the largest measurement, who are candidates for laparoscopic repair of the hernia, and who are able to commit to long-term followup. Laparoscopic repair will proceed as per the standard technique, using polyester mesh.
For subjects who agree to participate in this study, participation will last for 1 year. Subjects will undergo all the routine preoperative testing, the same as would be required if they were not participating in this study. This testing includes a blood sample and an electrocardiogram (ECG). Follow up visits will be done at 2 weeks after surgery, 6 weeks after surgery, and 1 year after surgery. Except for the 1 year visit, these office visits are routine and would be requested even if you were not participating in this study. At each of these visits, subjects will be asked about their level of pain and the amount and type of pain medication their are taking. Data gathered for this study will be on outcomes only.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459602
|United States, New York|
|Columbia University College of Physicians and Surgeons|
|New York, New York, United States, 10032|
|Principal Investigator:||Dennis L Fowler, MD||Columbia University College of Physicians and Surgeons|