How many patients have symptoms of early or late dumping after weight loss surgery and does these symptoms influence quality of life?
| ISRCTN | ISRCTN17666669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17666669 |
| Secondary identifying numbers | RTPO359a |
- Submission date
- 07/10/2017
- Registration date
- 12/10/2017
- Last edited
- 10/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Bariatric surgery is a weight loss surgery that reduces the size of their stomach. After weight loss surgery some patients develop complaints of dumping. Two forms of dumping exists: Early dumping, which starts early after a meal and resemble the complaints of a after dinner dip but then more heavily: symptoms of nausea, sleepiness, sweating, stomach ache etc. Late dumping mostly starts 1,5 hours after a meal and give complaints of hypoglycaemia (sweating, trembling, drowsiness or even coma). The aim of this study is to examine the prevalence of early and late dumping after bariatric surgery and examine the influence of this on patient’s quality of life. The aim of this study is to examine the prevalence of early and late dumping after bariatric surgery and the impact of this on quality of life.
Who can participate?
Adults aged 18 and 70 years old who have underwent bariatric surgery.
What does the study involve?
Participants are asked to fill in one questionnaire some time after their bariatric surgery which takes 15 minutes. The questionnaire asks about late and early dumping and the impact on their quality of life.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participation.
Where is the study run from?
Medical Center Leeuwarden (Netherlands)
When is the study starting and how long is it expected to run for?
January 2012 to May 2013
Who is funding the study?
Center for Obesity Netherlands, Medical Center Leeuwarden (Netherlands)
Who is the main contact?
Mrs Marloes Emous
marloes.emous@znb.nl
Contact information
Scientific
Medisch Centrum Leeuwarden
Henri Dunantweg 2
Leeuwarden
8934AD
Netherlands
 ORCID ID |
0000-0002-2223-3687 |
|---|
Study information
| Study design | Single-centre cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prevalence of dumping after bariatric surgery and impact on quality of life |
| Study objectives | Research question: What is the prevalence of early and late dumping after bariatric surgery and what is the influence on quality of life? |
| Ethics approval(s) | Regional Examination Committee for Patient-Based Research, 05/23/2012, ref: number RTPO 859a |
| Health condition(s) or problem(s) studied | Post-bariatric population and dumping syndrome |
| Intervention | Participants are asked to fill in one questionnaire some time after their bariatric surgery which takes 15 minutes. The questionnaire asks about late and early dumping and the impact on their quality of life. No further actions are required. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of late dumping is measured using the dumping severity score and questionnaire at one time point few years after bariatric surgery. |
| Secondary outcome measures | 1. Prevalence of early dumping is measured using the dumping severity score and questionnaire at one time point few years after bariatric surgery 2. Impact on quality of life is measured using the dumping severity score and questionnaire at one time point few years after bariatric surgery |
| Overall study start date | 01/01/2012 |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1250 |
| Key inclusion criteria | 1. All patients who underwent bariatric surgery in a single hospital between 2008 and 2011 2. Aged between 18 and 70 years 3. All genders |
| Key exclusion criteria | There is no exclusion criteria. |
| Date of first enrolment | 01/05/2012 |
| Date of final enrolment | 01/03/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leeuwarden
8934 AD
Netherlands
Sponsor information
Hospital/treatment centre
Henri Dunantweg 2
Leeuwarden
8934 AD
Netherlands
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/11/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. One paper about the prevalence of early and late dumping after primary gastric bypass and their influence on quality of life 2. 1 paper about the prevalence of early and late dumping in patients after sleeve gastrectomy and revisional gastric bypass |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Marloes Emous, surgeon and principal investigator at marloes.emous@znb.nl. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2017 | Yes | No | |
| Results article | results | 01/08/2018 | Yes | No |
Editorial Notes
10/08/2018: Publication references added.
13/10/2017: Internal edits.
