Comparison of preoperative diets before bariatric surgery with a randomized non-inferiority trial in order to compare the standard VLCD with a standard diet.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight loss (in kg) before operation
Secondary outcome
- operation time
- blood loss
- difficulty of procedure
- short term complications
- acceptance of diets according to patients
Background summary
Morbid obesity, defined as a body mass index (BMI) of > 40 kg/m² or > 35 kg/m²
with obesity-related comorbidities, is a rapidly growing problem in the western
society. In the United States, about 6 million people currently have a BMI of >
40 kg/m² and another 10 million people have a BMI of > 35 kg/m² with
comorbidities. Worldwide, the incidence of morbid obesity has doubled and about
300 million people are now obese [1, 2]. In the Netherlands the prevalence is
less disturbing but the incidence of morbid obesity is rising progressively to
1.5% of the total population [3]. At this moment surgical therapy is the only
treatment option for these patients that results in sufficient long-term weight
loss. Non-surgical approaches, like low energy diets and behavior modification,
are not successful in the long-term with respect to maintaining weight loss and
decreasing obesity-related comorbidities[4, 5].
In order to increase weight loss and minimize complications a preoperative diet
before bariatric has been advocated. However, the usual VLCD's are poorly
tolerated by patients. In this study we aim to compare two preoperative diets
in order to find the most suitable for this patient population.
Study objective
Comparison of preoperative diets before bariatric surgery with a randomized
non-inferiority trial in order to compare the standard VLCD with a standard
diet.
Study design
Randomized clinical trial of two preoperative diets before bariatric surgery
(gastric bypass) comparing standard diet and Prodimed
Intervention
Preoperative diet
Study burden and risks
No risks.
Burden: 1 questionnaire, 1 diet book filled out during 10 days and 1 extra OPD
visit.
Total: 120 minutes
Boerhaaveplein 7
Bergen op Zoom 4624 VT
NL
Boerhaaveplein 7
Bergen op Zoom 4624 VT
NL
Listed location countries
Age
Inclusion criteria
- BMI >40 kg/m2 or >35 kg/m2 with serious comorbidities
- after multidisciplinary consensus reached for gastric bypass surgery
Exclusion criteria
- psychologically unsuitable according to psychologist (i.e. serious psychiatric disorders)
- serious cardiopulmonary pathology (ASA 3 or higher)
- former gastric / bariatric procedures
- age < 18 or > 60 years
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 | NL41186.101.12 |