An observational study in Hernia, Ventral, sponsored by The University of Texas Health Science Center, Houston. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by The University of Texas Health Science Center, Houston · Observational
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's planned enrollment of 143 is above the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with a ventral hernia who are undergoing non-operative management of their hernia at LBJ General Hospital.
Exclusion Criteria:
Rate of surgical repair of the ventral hernias per patient year
Time frame: Once a year for 5 years
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
Change in pain from baseline using the Visual Analog Scale for Pain
Time frame: Once a year for 5 years
Change in patient function from baseline using the HerQLes Survey
Time frame: Once a year for 5 years
Change in patient quality of life from baseline using the HerQLes Survey
Time frame: Once a year for 5 years
Change in hernia size based on clinical exam or CT scan
Time frame: Once a year for 5 years
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston