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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351455
Other study ID # H-18609
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2006
Est. completion date January 2009

Study information

Verified date May 2023
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
smoking cessation

tighter diabetic control

diet and exercise program


Locations

Country Name City State
United States Michael E. DeBakey VA Medical Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Develop guidelines for hernia repair
Secondary To measure if life-style changes lower need for hernia repair
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