Incisional Hernia Outcomes Study Using Parietex Composite Mesh

Terminated

• Conditions: Incisional Hernia

• Registration Number: NCT00459602
• Lead Sponsor: Columbia University

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2007-04-10
• Study First Submitted QC: 2007-04-10
• Study First Posted: 2007-04-12
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog (VAS) scale	1 year	pain assessment

Trial Locations

Locations (1)

Columbia University College of Physicians and Surgeons; 🇺🇸 New York, New York, United States