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Watchful Waiting of Incisional Hernias

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00351455
First Posted: July 12, 2006
Last Update Posted: December 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baylor College of Medicine
  Purpose
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.

Condition Intervention
Incisional Hernia Ventral Hernia Umbilical Hernia Behavioral: smoking cessation Behavioral: tighter diabetic control Behavioral: diet and exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Watchful Waiting of Incisional Hernias: A Prospective Trial

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Develop guidelines for hernia repair

Secondary Outcome Measures:
  • To measure if life-style changes lower need for hernia repair

Estimated Enrollment: 50
Study Start Date: May 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351455


Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Charles Bellows, III, MD Baylor College of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00351455     History of Changes
Other Study ID Numbers: H-18609
First Submitted: July 7, 2006
First Posted: July 12, 2006
Last Update Posted: December 6, 2010
Last Verified: December 2010

Keywords provided by Baylor College of Medicine:
hernia
incisional hernia
ventral hernia
umbilical hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Incisional Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Infant, Newborn, Diseases