Incisional Hernia Outcomes Study Using Parietex Composite Mesh

This study has been terminated.
(Principal Investigator left institution.)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00459602
First received: April 10, 2007
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

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 Phase
Incisional Hernia
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Visual analog (VAS) scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    pain assessment


Enrollment: 22
Study Start Date: August 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgical clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459602

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

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00459602     History of Changes
Other Study ID Numbers: AAAA7985
Study First Received: April 10, 2007
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
laparoscopic surgery

ClinicalTrials.gov processed this record on March 30, 2015