Obesity Clinical Trial
Official title:
Prevalence and Impact of Chronic Oedema in a Population of Patients Prior to and Following Bariatric Surgery
NCT number | NCT03154593 |
Other study ID # | 16031 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | July 2018 |
Verified date | July 2018 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Persistent swelling (chronic oedema), e.g. of the legs, is quite a common condition, which
can cause a number of problems, including infections (cellulitis) in the swollen area and
ulceration. It seems to be particularly common in people who are overweight but this has not
been studied in detail. This study aims to address this gap in knowledge. It will take place
in two stages, running in parallel to each other with different groups of patients. The first
stage will determine how common persistent swelling is among patients attending weight
management services at the Royal Derby Hospital and how it impacts on every day life. The
second stage will determine whether weight loss surgery improves the swelling.
The results will inform future treatment guidelines for overweight patients who have
swelling. They will also inform the design of future research that will investigate the
effects of weight loss surgery in more detail, for example by testing out methods of
measuring fluid changes in the legs.
All new patients attending the weight loss service will be eligible to take part in the first
stage of the study, as long as they: give their informed consent to take part, and can speak
English (or have someone with them who speaks English). Participants will not have had weight
loss surgery previously. The Stage 1 assessment is expected to take about 40 minutes and
consists of: a single clinical assessment for each participant to identify the presence of
the swelling and its degree in each of the affected areas and, up to 3 questionnaires
concerning their quality of life and mobility.
Patients attending the programme, who have been referred for bariatric surgery, will take
part in the second stage of the study. Stage 2 will last approximately 13 months, during
which time the participants will be assessed 4 times - once before surgery and at 3, 6, and
12-month intervals after surgery. Each Stage 2 assessment is expected to take about 50
minutes and consists of: a clinical assessment and up to 5 questionnaires.
Status | Completed |
Enrollment | 78 |
Est. completion date | July 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults who have capacity to give informed consent. - Ability to understand the assessment questionnaires in English. Stage 1 - all patients accepted for referral. There are no co-morbidities that would exclude people. Stage 2 - patients that undergo bariatric surgery. Exclusion Criteria: - Patients under the lower age limit of 18. Stage 2 - By-Band-Sleeve study participants who are taking part in the randomisation part of the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Derby Hospital | Derby |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stage 1 - Prevalence of chronic oedema - using a clinical assessment | This will be achieved using: a clinical assessment to identify the presence or absence of chronic oedema. | 6 months | |
Primary | Stage 1 - Impact of chronic oedema - using a clinical assessment | This will be achieved using a clinical assessment to identify the degree of swelling in the affected areas. | 6 months | |
Primary | Stage 1 - Impact of chronic oedema - using questionnaires | This will be achieved using a range of quality of life questionnaires to identify the impact that the swelling has on the participants. | 6 months | |
Primary | Stage 2 - Definition of post-surgery changes in chronic oedema - using clinical assessments | This will be achieved by serial clinical assessment measures over a 12-month follow up after surgery. | Over 1 year, 6 months | |
Secondary | Stage 1 - Comparison of quality of life - using questionnaires | The quality of life of participants with and without chronic oedema will be compared, using the scores from the quality of life questionnaires. | 6 months | |
Secondary | Stage 1 - Defining chronic oedema - using bioimpedance data | The bioimpedance data (measures total fluid within the legs) will be used to determine if the technique can define chronic oedema in this setting. | 6 months | |
Secondary | Stage 1 - Defining chronic oedema - using tissue dielectric constant data | The tissue dielectric constant data (measures fluid levels at different points) will be used to determine if the technique can define chronic oedema in this setting. | 6 months | |
Secondary | Stage 1 - Presence/severity of oedema - using questionnaires | The questionnaires will be used to collect data about the presence/severity of swelling of the patients. These will be important as they will help to determine the impact of chronic oedema on everyday life. | 6 months | |
Secondary | Stage 2 - Measuring oedema changes - using bioimpedance data | The bioimpedance technique will be used to measure changes in the oedema from the baseline (pre-operative) measurement. The use of this technique will be validated by comparing the results with clinical assessment and limb volume measurements. | Over 1 year, 6 months | |
Secondary | Stage 2 - Measuring oedema changes - using tissue dielectric constant data | The tissue dielectric constant technique will be used to measure changes in the oedema from the baseline (pre-operative) measurement. The use of this technique will be validated by comparing the results with clinical assessment and limb volume measurements. | Over 1 year, 6 months | |
Secondary | Stage 2 - Comparison over a 12-month period - comparing clinical assessments | The clinical assessments [presence/severity of swelling and wounds (if present)] of the patients from their preoperative to their 12-month post-operative appointment will be compared in order to determine the impact of weight loss on chronic oedema. The effect sizes of these changes will be used to inform future study design and sample size calculation. | Over 1 year, 6 months | |
Secondary | Stage 2 - Comparison over a 12-month period - comparing questionnaires | The quality of life scores of the patients from their preoperative to their 12-month post-operative appointment will be compared in order to determine the impact of weight loss on chronic oedema. The effect sizes of these changes will be used to inform future study design and sample size calculation. | Over 1 year, 6 months | |
Secondary | Stage 2 - Future sample size calculation - using recruitment data | Recruitment data (the percentage of eligible patients who consent to take part in the study, and the number withdrawing or not completing the study follow-up) will be used to inform sample size calculation for the future study. | Over 1 year, 6 months |
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