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Watchful Waiting of Incisional Hernias

Baylor College of Medicine logo

Baylor College of Medicine

Status

Completed

Conditions

Umbilical Hernia
Incisional Hernia
Ventral Hernia

Treatments

Behavioral: smoking cessation
Behavioral: diet and exercise program
Behavioral: tighter diabetic control

Study type

Interventional

Funder types

Other

Identifiers

NCT00351455
H-18609

Details and patient eligibility

About

This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.

Full description

This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.

Subjects will fill out three survey forms on quality of life and pain at baseline and again at six and 12 months. Measurements of change in hernia size will be made, life-style changes such as smoking cessation, weight-loss, tighter control of diabetes will be initiated for outcome comparison with controls.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. abdominal hernia greater than 3 cm2
  2. 18 years of age
  3. able to give informed consent

Exclusion criteria

  1. abdominal hernia less than 3 cm2 or greater than 127 cm2
  2. unable to return to clinic for follow-up visits

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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