NCT01115400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

April 12, 2010

Last Update Submit

April 12, 2022

Conditions

Keywords

Abdominal Wall Herniaquality of life

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

HerniaHernia, Abdominal

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael J Rosen, MD

    Univesity Hospitals Case Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

May 4, 2010

Study Start

July 1, 2007

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations