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Incisional Hernia Outcomes Study Using Parietex Composite Mesh

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ClinicalTrials.gov Identifier: NCT00459602
Recruitment Status : Terminated (Principal Investigator left institution.)
First Posted : April 12, 2007
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Phase
Incisional Hernia Phase 4

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
Actual Enrollment : 22 participants
Time Perspective: Prospective
Official Title: A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh
Study Start Date : August 2004
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :
  1. Visual analog (VAS) scale [ Time Frame: 1 year ]
    pain assessment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical clinic

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459602

United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Dennis L Fowler, MD Columbia University
More Information

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00459602     History of Changes
Other Study ID Numbers: AAAA7985
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Columbia University:
laparoscopic surgery

Additional relevant MeSH terms:
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes