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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

July 7, 2006
December 2, 2010
May 2006
January 2009   (final data collection date for primary outcome measure)
Develop guidelines for hernia repair
Same as current
Complete list of historical versions of study NCT00351455 on ClinicalTrials.gov Archive Site
To measure if life-style changes lower need for hernia repair
Same as current
Not Provided
Not Provided
 
Watchful Waiting of Incisional Hernias
Watchful Waiting of Incisional Hernias: A Prospective Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Incisional Hernia
  • Ventral Hernia
  • Umbilical Hernia
  • Behavioral: smoking cessation
  • Behavioral: tighter diabetic control
  • Behavioral: diet and exercise program
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00351455
H-18609
No
Not Provided
Baylor College of Medicine
Not Provided
Principal Investigator: Charles Bellows, III, MD Baylor College of Medicine
Baylor College of Medicine
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP