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Non-Op Management of Ventral Hernia Patients

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Unknown

Conditions

Hernia, Ventral

Study type

Observational

Funder types

Other

Identifiers

NCT02457364
HSC-MS-15-0372

Details and patient eligibility

About

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.

Enrollment

143 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients undergoing initial non-operative management as chosen by current practice patterns
  • All patients who opt for non-operative management due to personal choice, lack of symptoms or concerns regarding surgical risks.
  • Age 18 or older

Exclusion criteria

  • Patient meets surgery criteria but elects for surgery within 1 year due to personal scheduling
  • Patient smokes < 1 pack per day, is actively quitting smoking, and desires to follow-up within 3 months upon smoking cessation
  • Patient with BMI < 35 kg/m2, is actively losing weight, and desires to follow-up within 3 months upon weight loss goals being met
  • Patient is unlikely to be able to follow-up due to no personal or home phone
  • Patient is enrolled in another trial

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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