A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Columbia University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Visual analog (VAS) scale
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •incisional hernia suitable for repair by laparoscopic techniques
Exclusion Criteria
- •not a candidate for laparoscopic surgery
- •hernia not suitable for laparoscopic repair techniques
Outcomes
Primary Outcomes
Visual analog (VAS) scale
Time Frame: 1 year
pain assessment
Secondary Outcomes
No secondary outcomes reported