Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01115400 |
Other study ID # |
05-07-31 |
Secondary ID |
05-07-31 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 2007 |
Est. completion date |
August 2012 |
Study information
Verified date |
April 2022 |
Source |
University Hospitals Cleveland Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to evaluate the quality of life in patients with abdominal wall
hernias using a user-friendly survey that is designed specifically for this population of
patients. The investigators would like to use this survey to elucidate how quality of life of
the patient is changed with the presence of an abdominal wall hernia.
Description:
Abdominal hernia repair is one of the most common general surgery procedures performed in the
United States. Hernia occurrences after prior abdominal surgeries can range anywhere from
20-50%. Small abdominal defects (<3cm) can generally be repaired primarily, however, anything
larger usually requires placement of mesh. If the defects are massive and complicated from
prior repairs; they often require prolonged operating time, and sometimes even
multiple-staged procedures to complete repair. In patients with co-morbidities and needing
abdominal hernia repair, the surgeons are generally cautious in recommending surgical
treatments as long as no acute emergency exists due to the hernia. Due to the high
post-operative complications in these patients, the risks of the surgery may outweigh the
benefit of the repair. As a result, many patients with large, complicated hernias are
delegated to medical management including the use of abdominal binders, conservative
treatments of enterocutaneous fistula and chronic infections. However, these decisions are
frequently made from the point of the view of the surgeons, and not the patients.
The investigators would like to evaluate how the patients perceive living with abdominal
hernias, and how they view the effect of their quality of life affected by hernias. If the
quality of life in these patients is severely affected, the investigators may be able to use
that information to stratify these patients and to gauge the necessity of future repairs.
Currently, there is no quality of life survey target specifically for patients with abdominal
hernia. Most institutions use the SF36 or a shortened SF36 form to evaluate quality of life.
However, the SF36 is generic and cumbersome. It was originally designed for renal failure
patients and is not entirely appropriate for hernia patients. This protocol will be the first
one to use factors that are specific to hernia patients to accurately describe the patient's
quality of life. Also, by generating a quality of life score for patients with different
degrees of hernias, the investigators will be able to better stratify patients who may
benefit from the hernia repair more than what the surgeons perceive because of the patients'
other co-morbidities. And furthermore, the investigators would also like to show the
improvement in quality of life in these patients after their successful repairs.
The Hernia QOL survey will be compared with the SF12 (a shortened version of the SF36).