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Completed

NCT Number: NCT01115400

Quality of Life Evaluations in Patients With Abdominal Wall Hernias

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are 18 years of age and older
  • Subjects of either sex
  • Subjects with the diagnosis of abdominal wall hernias
  • Subjects who agree to participate in the study program

Exclusion criteria

  • Subjects who present to clinic with acute incarceration or strangulation of bowel
  • Subjects who are unable to read or write to complete the survey
  • Pregnant women, minors, psychiatric patients and prisoners

Treatment and study plan

Primary outcomes

  1. Quality of life perception

    Time frame: up to 1 year

    The investigators would like to evaluate how the patients perceive living with abdominal hernias, and how they view the changes from their baseline in their quality of life since their hernia. 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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Acronym: QOL

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 4, 2010
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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