Watchful Waiting of Incisional Hernias
Primary Purpose
Incisional Hernia, Ventral Hernia, Umbilical Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
smoking cessation
tighter diabetic control
diet and exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia focused on measuring hernia, incisional hernia, ventral hernia, umbilical hernia
Eligibility Criteria
Inclusion Criteria: abdominal hernia greater than 3 cm2 18 years of age able to give informed consent Exclusion Criteria: abdominal hernia less than 3 cm2 or greater than 127 cm2 unable to return to clinic for follow-up visits
Sites / Locations
- Michael E. DeBakey VA Medical Center
Outcomes
Primary Outcome Measures
Develop guidelines for hernia repair
Secondary Outcome Measures
To measure if life-style changes lower need for hernia repair
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00351455
Brief Title
Watchful Waiting of Incisional Hernias
Official Title
Watchful Waiting of Incisional Hernias: A Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Ventral Hernia, Umbilical Hernia
Keywords
hernia, incisional hernia, ventral hernia, umbilical hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
tighter diabetic control
Intervention Type
Behavioral
Intervention Name(s)
diet and exercise program
Primary Outcome Measure Information:
Title
Develop guidelines for hernia repair
Secondary Outcome Measure Information:
Title
To measure if life-style changes lower need for hernia repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
abdominal hernia greater than 3 cm2
18 years of age
able to give informed consent
Exclusion Criteria:
abdominal hernia less than 3 cm2 or greater than 127 cm2
unable to return to clinic for follow-up visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bellows, III, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Watchful Waiting of Incisional Hernias
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