Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Marloes Emous
ORCID ID
http://orcid.org/0000-0002-2223-3687
Contact details
Medisch Centrum Leeuwarden
Henri Dunantweg 2
Leeuwarden
8934AD
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RTPO359a
Study information
Scientific title
Prevalence of dumping after bariatric surgery and impact on quality of life
Acronym
Study hypothesis
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
Regional Examination Committee for Patient-Based Research, 05/23/2012, ref: number RTPO 859a
Study design
Single-centre cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2012
Overall trial end date
01/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1250
Participant exclusion criteria
There is no exclusion criteria.
Recruitment start date
01/05/2012
Recruitment end date
01/03/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Medical Center Leeuwarden
Henri Dunantweg 2
Leeuwarden
8934 AD
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Center for Obesity Netherlands, Medical Center Leeuwarden
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
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.
Intention to publish date
01/11/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29858129
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28624531