Chronic OedemaNCT03154593
Prevalence of Chronic Oedema in Obese Patients
An observational study of Chronic Oedema and Obesity, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Oedema, Obesity
- What is being tested?
- Stage 2 - Bariatric Surgery
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Stage 1 will assess patients attending the Tier 3 weight management programme at the Royal Derby Hospital, who are accepted for referral and provide informed consent to take part in the study. Stage 2 will assess patients attending the Tier 4 programme who undergo bariatric surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Impact of Chronic Oedema in a Population of Patients Prior to and Following Bariatric Surgery
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.
Read more
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.
Read the detailed description
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.
None of the assessments included in either stage should cause any pain or discomfort.
The questionnaires, which will be completed in both stages, concern the participants' quality of life and mobility.
- The EQ-5D questionnaire compares quality of life over time well and can assess the health utility of the participants. The EQ-5D scores can be used to calculate quality-adjusted life years.
- The GAD-7 (Generalised Anxiety Disorder 7-item Scale) and PHQ-9 (Patient Health Questionnaire - 9) questionnaires will be used to assess the anxiety/depression of the participants. Stage 1 participants will have completed these before their study assessments so the study team will obtain these results from their clinical records. Stage 2 participants will complete the questionnaires as part of the study assessments.
- The SF-36 questionnaire will assess the mobility of the participants and give general health-related quality of life scores.
- The LYMQOL questionnaire, which will only be given to participants who have oedema, is a validated, condition-specific, quality of life instrument. It can be used both: to assess lymphoedema of the limbs and as an outcome measure.
- Conditions
- Chronic Oedema, Obesity
- Being tested
- Stage 2 - Bariatric Surgery
- Keywords
- Prevalence
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage 2 - Bariatric SurgeryOther
This observational study follows patients after routine bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Stage 1 will determine the prevalence of chronic oedema among patients attending weight management services at the Royal Derby Hospital and how it impacts on every day life. | |
| Stage 2 | Stage 2 will determine whether bariatric surgery improves the oedema. Receives: Other: Stage 2 - Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: Over 1 year, 6 months
Secondary outcomes (9)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: Over 1 year, 6 months
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.
Measured: Over 1 year, 6 months
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.
Measured: Over 1 year, 6 months
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.
Measured: Over 1 year, 6 months
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.
Measured: Over 1 year, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startAug 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic OedemaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vaughan L Keeley, PhD, FRCP, Principal investigator, University of Nottingham, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154593
- Sponsor's protocol ID
- 16031
- Status last verified
- Jul 2018
- First submitted
- 5 May 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be sent out after the study has ended to participants who request them.
Publications
Newman A, Keeley V, Pinnington L, Green C, Riches K, Franks PJ, Idris I, Moffatt CJ. Prevalence and Impact of Chronic Edema in Bariatric Patients: A LIMPRINT Study. Lymphat Res Biol. 2021 Oct;19(5):431-441. doi: 10.1089/lrb.2021.0055.
PubMed 34672794
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Chronic Oedema in a Population of Patients Prior to and Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03154593
- Acronym / sponsor ID
- 16031
- Conditions
- Chronic Oedema, Obesity
- Keywords
- Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 May 2017 (actual)
- 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.
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.
Detailed description
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.
None of the assessments included in either stage should cause any pain or discomfort.
The questionnaires, which will be completed in both stages, concern the participants' quality of life and mobility.
- The EQ-5D questionnaire compares quality of life over time well and can assess the health utility of the participants. The EQ-5D scores can be used to calculate quality-adjusted life years.
- The GAD-7 (Generalised Anxiety Disorder 7-item Scale) and PHQ-9 (Patient Health Questionnaire - 9) questionnaires will be used to assess the anxiety/depression of the participants. Stage 1 participants will have completed these before their study assessments so the study team will obtain these results from their clinical records. Stage 2 participants will complete the questionnaires as part of the study assessments.
- The SF-36 questionnaire will assess the mobility of the participants and give general health-related quality of life scores.
- The LYMQOL questionnaire, which will only be given to participants who have oedema, is a validated, condition-specific, quality of life instrument. It can be used both: to assess lymphoedema of the limbs and as an outcome measure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | – | –Stage 1 will determine the prevalence of chronic oedema among patients attending weight management services at the Royal Derby Hospital and how it impacts on every day life. |
| Stage 2 | – | Other: Stage 2 - Bariatric SurgeryStage 2 will determine whether bariatric surgery improves the oedema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 1 will assess patients attending the Tier 3 weight management programme at the Royal Derby Hospital, who are accepted for referral and provide informed consent to take part in the study. Stage 2 will assess patients attending the Tier 4 programme who undergo bariatric surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stage 2 - Bariatric SurgeryThis observational study follows patients after routine bariatric surgery. | Other | Stage 2 |
Primary outcome
Stage 1 - Prevalence of chronic oedema - using a clinical assessment
Time frame: 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 a clinical assessment
Time frame: 6 months
This will be achieved using a clinical assessment to identify the degree of swelling in the affected areas.
Stage 1 - Impact of chronic oedema - using questionnaires
Time frame: 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
Time frame: Over 1 year, 6 months
This will be achieved by serial clinical assessment measures over a 12-month follow up after surgery.
9 secondary outcomes
Stage 1 - Comparison of quality of life - using questionnaires
Time frame: 6 months
Stage 1 - Defining chronic oedema - using bioimpedance data
Time frame: 6 months
Stage 1 - Defining chronic oedema - using tissue dielectric constant data
Time frame: 6 months
Stage 1 - Presence/severity of oedema - using questionnaires
Time frame: 6 months
Stage 2 - Measuring oedema changes - using bioimpedance data
Time frame: Over 1 year, 6 months
Stage 2 - Measuring oedema changes - using tissue dielectric constant data
Time frame: Over 1 year, 6 months
Stage 2 - Comparison over a 12-month period - comparing clinical assessments
Time frame: Over 1 year, 6 months
Stage 2 - Comparison over a 12-month period - comparing questionnaires
Time frame: Over 1 year, 6 months
Stage 2 - Future sample size calculation - using recruitment data
Time frame: Over 1 year, 6 months
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 5 Sep 2018.
- Derived from this study: PubMed 34672794Newman A, Keeley V, Pinnington L, Green C, Riches K, Franks PJ, Idris I, Moffatt CJ. Prevalence and Impact of Chronic Edema in Bariatric Patients: A LIMPRINT Study. Lymphat Res Biol. 2021 Oct;19(5):431-441. doi: 10.1089/lrb.2021.0055.
- Individual participant dataSharing planned: Yes. Individual participant data will be sent out after the study has ended to participants who request them.
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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.
Vaughan L Keeley, PhD, FRCP principal investigator
University of Nottingham, School of Medicine
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 Chronic Oedema and Obesity, run by University of Nottingham at 1 site in United Kingdom.
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 2 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 5 Sep 2018. 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 Kingdom. 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?
Stage 1 - Prevalence of chronic oedema - using a clinical assessment (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154593, which also lists 1 linked publication.
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 5 Sep 2018.