A Study of the Development and Validation of an Ascites-Specific Patient Reported Outcomes Questionnaire
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-009366
Sponsor Protocol Number: 14-009366
About this study
The purpose of this study is to develop and validate a brief patient reported outcomes questionaire that is responsive to ascites-related symptoms in liver cirrhosis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Ascites Patients
- Age ≥ 18 years
- Experiencing symptomatic ascites based on
- Cirrhosis defined by histological, clinical or radiological criteria
- Abdominal malignancy or peritoneal carcinomatosis
- Control Group
- Cirrhosis defined by histological, clinical or radiological criteria
- No signs of ascites based on physical examination or ultrasound
Exclusion Criteria
- Impaired cognitive function as deemed by the investigators such as hepatic encephalopathy > Grade 2 following the West Haven Criteria [14] or as a result of brain metastasis
- Unable to speak or read English fluently
- Admitted to the hospital at time of paracentesis
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Patrick Kamath, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available