Primary Objective: To assess the effect of bariatric and, eventually, subsequent body contouring surgery on appearance and HRQoL over time using the BODY-Q questionnaire. Secondary Objectives: The secondary objectives are (1) psychometric validation…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Bariatrische chirurgie en body contouring chirurgie bij obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter:
- Differences in mean BODY-Q scores (Δ mean BODY-Q scores) pre-bariatric
surgery and (4 and 12 months, 2,3,4,5 years) post-bariatric surgery
- Differences in mean BODY-Q scores (Δ mean BODY-Q scores) pre-bariatric
surgery and (3 and 12 months, 2,3,4,5 years) post-body contouring surgery
- Differences in mean BODY-Q scores (Δ mean BODY-Q scores) between patients who
demand and not demand for body contouring surgery
- Differences in mean BODY-Q scores (Δ mean BODY-Q scores) between patients who
desire and undergo or not undergo body contouring surgery
Secondary outcome
Secondary study parameters:
- Predictive variables of improvements in mean BODY-Q scores (Δ mean BODY-Q
scores)
- Predictive domain BODY-Q scores who proceed to body contouring surgery
- Predictive variables of patients who desire body contouring surgery
- Predictive variables of patients who will undergo body contouring surgery
- Long term weight loss with or without body contouring surgery: percentage
excess weight loss (%EWL), Percentage total weight loss (%ΔTWL) and change in
body mass index (ΔBMI)
Background summary
Bariatric surgery is considered the most effective treatment option for morbid
obesity in the long-term. The substantial weight loss, however, leaves patients
with excessive skin, which can have a negative impact on appearance and
health-related quality of life (HRQoL). Body contouring surgery has
considerable potential to restore these corollaries. Presently, limited data
are available documenting appearance and HRQoL in both the bariatric and body
contouring population, partly due to the lack of HRQoL measurements for this
specific population. Therefore, a longitudinal study is needed to measure HRQoL
changes over time during the total weight loss journey. A new patient-reported
outcome measure (PROM), the BODY-Q, is the first to cover both types of surgery
and has been translated for use in Dutch patients. BODY-Q scales measure
appearance (of various body areas), HRQoL, and the patient experience of care.
Psychometric validation of the BODY-Q will enable measurement of clinical
effectiveness and economic efficiencies from the patients* perspective in the
Netherlands. Furthermore, to date surgeons lack precision when predicting which
bariatric surgery patients will proceed to body contouring surgery.
Additionally, as weight regain negatively impacts patient health and long-term
costs in the healthcare system, better evidence is needed on the influence of
body contouring surgery on weight control following bariatric surgery.
Appropriate prediction of these concerns will enable surgeons to communicate
false expectations, improve patient satisfaction and improve consult
efficiency. This will be the first nationally representative research on this
subject and these data will be needed to inform patient selection and
education, comparative effectiveness research, and healthcare policy decisions.
Study objective
Primary Objective: To assess the effect of bariatric and, eventually,
subsequent body contouring surgery on appearance and HRQoL over time using the
BODY-Q questionnaire. Secondary Objectives: The secondary objectives are (1)
psychometric validation of the Dutch translated BODY-Q questionnaire (2) to
identify predictive variables correlated with amelioration in BODY-Q scores (3)
to identify predictive domain BODY-Q scores correlated with the demand for body
contouring surgery (4) to identify predictive variables correlated with the
demand for body contouring surgery (5) to identify predictive variables
correlated with patients who undergo body contouring surgery (6) to assess the
influence of body-contouring surgery on long-term weight control.
Study design
Multicentre prospective longitudinal cohort study
Study burden and risks
Patients will not have to undergo additional invasive procedures by
participating in the present study. Therefore, we anticipate no additional
risks by undertaking the present study and no liability insurance is needed.
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled bariatric surgery in the OLVG West Hospital, Amsterdam; Catharina Hospital, Eindhoven; St. Antonius Hospital, Nieuwegein; the Netherlands.
Exclusion criteria
- Age > 65 years of age < 18 years
- Unable to read Dutch
- Unable to sign informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60699.100.17 |