Watchful Waiting of Incisional Hernias - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00351455

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

MedlinePlus related topics: Hernia Quitting Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Watchful Waiting of Incisional Hernias: A Prospective Trial

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
Estimated Study Completion Date:	May 2009

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351455

Contacts

Contact: Nancy Logan, MA, CCRP

713-791-1414 ext 5455

njarrar@bcm.edu

Locations

United States, Texas
Michael E. DeBakey VA Medical Center	Recruiting
Houston, Texas, United States, 77030
Contact: Nancy Logan, MA, CCRP 713-791-1414 ext 5455 njarrar@bcm.edu

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Charles Bellows, III, MD

Baylor College of Medicine

More Information

Study ID Numbers:	H-18609
Study First Received:	July 7, 2006
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00351455
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

hernia
incisional hernia
ventral hernia
umbilical hernia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal

Hernia, Umbilical
Hernia, Ventral
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on January 14, 2009