Clinical Trial: Non-Op Management of Ventral Hernia Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair

Brief Summary: Ventral hernias are among the most common surgical diseases among patients.The natural history of patients with ventral hernias who are managed non-operatively is unknown. The aim of this prospective trial is to document the natural history of patients who are undergoing initially non-operative management. The investigators hypothesize that 1) the risk of emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is high, and 3) patients managed non-operatively will develop increasing hernia size and symptom progression. This is a prospective observational study of all patients undergoing non-operative management at LBJ General Hospital. Patients will be consented and then followed for 5 years. Phone interviews will be done with these patients yearly to assess surgical and medical history, information about their hernia, including pain level due to the hernia, as well as function and quality of life.

Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: Rate of surgical repair of the ventral hernias per patient year [ Time Frame: Once a year for 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of emergency repair of ventral hernias per patient year [ Time Frame: Once a year for 5 years ]
  • Rate of elective repair of ventral hernias per patient year [ Time Frame: Once a year for 5 years ]
  • Rate of emergency room visits per patient year [ Time Frame: Once a year for 5 years ]


Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: May 20, 2015
Date Started: July 2015
Date Completion: June 2020
Last Updated: May 15, 2017
Last Verified: May 2017