HerniaQOLNCT01115400
Quality of Life Evaluations in Patients With Abdominal Wall Hernias
An observational study of Hernia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This protocol will involve patients presenting to University Hospitals Case Medical Center for evaluation of abdominal hernias. The study population will include all adult patients with the diagnosis of abdominal wall hernias, without incarceration or strangulation of bowels. The investigators will need about 90 subjects to participate in this study. The survey will be entirely anonymous; no patient information will be given out in any part of the survey.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read the detailed 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).
- Conditions
- Hernia
- Keywords
- Abdominal Wall Hernia, quality of life
- Medical subject headings
- Hernia, Hernia, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life perception
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
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJul 2007
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Rosen, MD, Principal investigator, Univesity Hospitals Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115400
- Sponsor's protocol ID
- 05-07-31
- Other IDs
- 05-07-31
- Acronym
- QOL
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2010
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Evaluations in Patients With Abdominal Wall Hernias
- ClinicalTrials.gov ID
- NCT01115400
- Acronym / sponsor ID
- QOL / 05-07-31
- Conditions
- Hernia
- Keywords
- Abdominal Wall Hernia, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This protocol will involve patients presenting to University Hospitals Case Medical Center for evaluation of abdominal hernias. The study population will include all adult patients with the diagnosis of abdominal wall hernias, without incarceration or strangulation of bowels. The investigators will need about 90 subjects to participate in this study. The survey will be entirely anonymous; no patient information will be given out in any part of the survey.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Rosen, MD principal investigator
Univesity Hospitals Case Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life perception (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.