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Watchful Waiting of Incisional Hernias

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00351455
First received: July 7, 2006
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Watchful Waiting of Incisional Hernias: A Prospective Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00351455     History of Changes
Other Study ID Numbers: H-18609
Study First Received: July 7, 2006
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Hernia, Ventral
 Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 16, 2013