Prevalence and Impact of Chronic Oedema in a Population of Patients Prior to and Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Stage 1 - Prevalence of chronic oedema - using a clinical assessment
研究概览
简要总结
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.
详细描述
The clinical assessments included in both stages of the study will identify the presence and severity of swelling in each of the affected areas. Each assessment will consist of a clinical examination of the patient's legs and abdomen to look for swelling and changes in the skin associated with this.
Assessments carried out in Stage 1 will include bioimpedance and tissue dielectric constant (TDC) techniques.
- Bioimpedance measures the total fluid within a limb. This test passes an extremely small electrical current through the participant's body and measures the resistance to the flow of this current. The participant will not feel anything when the measurement is carried out as the current is very small, similar to the strength of a watch battery. If the participant is able to, the test will be undertaken with the participant lying down on an examination couch or sitting in a chair. Small stickers will be placed on the participant's hands and feet, and clips attached to these.
- The TDC measures fluid levels at different points. In order to record these fluid levels, a probe will be placed against the participants' skin on their feet, lower legs, and thighs.
Assessments carried out in Stage 2 will include bioimpedance, TDC, and also perometry (or measuring using a tape measure).
- This test measures the size and shape of the participants' legs, and can be undertaken by one of two methods depending on their mobility. If they need to stay in a chair or examination couch during the assessment, the size of their legs will be measured at different points using a tape measure. However, if possible, a device called a perometer will be used. Participants will be asked to stand with one leg in the frame of the perometer while it is moved up and down the leg. The frame contains lights which are used to measure the size and shape of the limb.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients under the lower age limit of
- •Stage 2 - By-Band-Sleeve study participants who are taking part in the randomisation part of the study.
结局指标
主要结局
Stage 1 - Prevalence of chronic oedema - using a clinical assessment
时间窗: 6 months
This will be achieved using: a clinical assessment to identify the presence or absence of chronic oedema.
Stage 1 - Impact of chronic oedema - using questionnaires
时间窗: 6 months
This will be achieved using a range of quality of life questionnaires to identify the impact that the swelling has on the participants.
Stage 2 - Definition of post-surgery changes in chronic oedema - using clinical assessments
时间窗: Over 1 year, 6 months
This will be achieved by serial clinical assessment measures over a 12-month follow up after surgery.
Stage 1 - Impact of chronic oedema - using a clinical assessment
时间窗: 6 months
This will be achieved using a clinical assessment to identify the degree of swelling in the affected areas.
次要结局
- Stage 1 - Defining chronic oedema - using bioimpedance data(6 months)
- Stage 1 - Presence/severity of oedema - using questionnaires(6 months)
- Stage 2 - Measuring oedema changes - using bioimpedance data(Over 1 year, 6 months)
- Stage 2 - Comparison over a 12-month period - comparing questionnaires(Over 1 year, 6 months)
- Stage 1 - Comparison of quality of life - using questionnaires(6 months)
- Stage 1 - Defining chronic oedema - using tissue dielectric constant data(6 months)
- Stage 2 - Comparison over a 12-month period - comparing clinical assessments(Over 1 year, 6 months)
- Stage 2 - Measuring oedema changes - using tissue dielectric constant data(Over 1 year, 6 months)
- Stage 2 - Future sample size calculation - using recruitment data(Over 1 year, 6 months)