Incisional Hernia Outcomes Study Using Parietex Composite Mesh

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Incisional Hernia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group