Clinical Trial: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

Brief Summary: This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.

Detailed Summary:
Sponsor: University of California, San Diego

Current Primary Outcome:

  • To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). [ Time Frame: 1 Year ]
  • To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). [ Time Frame: 1 Year ]


Original Primary Outcome:

  • Safety and Efficacy as measured by pain and temperature log post-op [ Time Frame: 1 month ]
    Patient will be given a 7-day pain and temperature log on which they will record pain/temperature for 7 days post-op.
  • Safety and efficacy as measured by # of adverse events. [ Time Frame: 1 Year ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Diego

Dates:
Date Received: July 14, 2011
Date Started: January 2009
Date Completion: January 2019
Last Updated: October 24, 2016
Last Verified: October 2016