Incisional Hernia Outcomes Study Using Parietex Composite Mesh

Incisional Hernia Clinical Trial

Official title:

A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00459602
• Other study ID #: AAAA7985
• Status: Terminated
• Phase: Phase 4
• First received: April 10, 2007
• Last updated: March 25, 2015
• Start date: August 2004
• Est. completion date: September 2008

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
United States	Columbia University College of Physicians and Surgeons	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog (VAS) scale	pain assessment	1 year	Yes