Condition category
Surgery
Date applied
07/10/2017
Date assigned
12/10/2017
Last edited
13/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

RTPO

Sponsor details

Henri Dunantweg 2
Leeuwarden
8934 AD
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/10/2017: Internal edits.