The primary objective is to evaluate the effect of preoperative weight loss (by means of a 14-day low-calorie diet) on the operative time of the RYGB procedure. The first secondary objective is to evaluate the effect of preoperative weight loss on…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the difference in operative time of the RYGB
procedure between the intervention and control group, retrieved from electronic
medical records after surgery.
Secondary outcome
1. The first secondary outcome is the difference in (perceived) ease of the
RYGB procedure between the intervention and control group, assessed by a
surgery score sheet. This surgery score sheet was constructed in cooperation
with surgeons and is based on the subsequent steps of the RYGB procedure.
2. The second secondary outcome is the difference in postoperative weight loss
between the intervention and control group, assessed by body weight
measurements during regular follow-up visits.
The tertiary outcome of this study is the feasibility, compliance and safety of
the diet. We will asses if the diet can be implemented in the standard
nutritional care procedure for bariatric patients at Vitalys. Opinion of both
patients and dietitians will be taken into account. Besides, short term
complication rates and degree of wound healing will be used as an indication
for safety.
Background summary
Bariatric surgery is the most effective method of treating morbid obesity, of
which RYGB is one of the most commonly performed bariatric procedures.
Bariatric guidelines recommend a preoperative weight loss of 5%, to reduce the
risk of operative complications. Many bariatric centres already advice patients
to lose weight before they undergo surgery by recommending a preoperative diet.
Nevertheless, Vitalys, one of the largest bariatric surgery clinics, does not
require their patients to follow a preoperative weight loss diet, as the
results in the literature on the improvement of surgical procedure and outcomes
are still contradicting. We hypothesise that preoperative weight loss (by
following a 14-day low-calorie diet) will improve the operative time, ease of
the RYGB procedure and postoperative outcome on long-term weight loss, in
comparison to the standard nutritional care of Vitalys.
Study objective
The primary objective is to evaluate the effect of preoperative weight loss (by
means of a 14-day low-calorie diet) on the operative time of the RYGB
procedure.
The first secondary objective is to evaluate the effect of preoperative weight
loss on the (perceived) ease of the RYGB procedure.
The second secondary objective is to evaluate the effect of preoperative weight
loss on postoperative weight loss (up to 5 years).
The tertiary objective is to evaluate if the diet can be implemented into the
standard nutritional care procedure for bariatric patients undergoing surgery
at Vitalys. This will be based on patients' experiences and compliance,
experiencies of the dietitians and short term complication rate (within 30
days) and degree of wound healing 4 weeks post-surgery.
Study design
This experimental study will use a two-arm randomised single-blind controlled
trial design to evaluate the effect of preoperative weight loss (by following a
14-day low calorie diet) on the operative time and ease of RYGB procedure and
postoperative outcomes on long-term weight loss, and compare this to the
standard nutritional care procedure. A total of 80 patients undergoing RYGB
surgery will be recruited at Vitalys, Rijnstate Hospital Arnhem and patients
will be randomly assigned to the intervention group (n=40) or control group
(n=40).
Intervention
The intervention group (n=40) will follow a 14-day low-calorie diet, providing
about 900 kcal (women) and 1000 kcal (men) a day by using meal replacements.
The control group (n=40) will follow the standard nutritional care procedure
(no diet).
Study burden and risks
The risk of participating in this study is small and the burden is kept to a
minimum, as following an energy-restricted preoperative diet is assumed to be
harmless and is clinical practice in many other bariatric centres. The meal
replacements that participants will receive can be prepared at home.
Participants will be asked to complete a food and physical activity diary and
will be contacted twice to conduct a short diet feasibility questionnaire by
phone. The anthropometric measurements will mostly take place during the
regular visits at the hospital or dietitian. The entire study may imply max one
extra visit.
With this study, we expect to show that preoperative weight loss (by means of a
14-day low-calorie diet) will effectively improve the operative time, the ease
of the RYGB procedure and postoperative outcomes on long-term weight loss.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
Next to the general inclusion criteria for undergoing bariatric surgery,
participants must meet all the following criteria:
• 18-65 years
• Undergoing primary RYGB surgery at Vitalys, Rijnstate Hospital (meeting all
criteria for undergoing RYGB + approval of surgeon)
• Able to prepare meal replacements at home
Exclusion criteria
Participants are excluded from the study if they meet any of the following
criteria:
• Undergoing another bariatric procedure than primary RYGB.
• Diabetes Mellitus
• Having contraindication for the usage of the meal replacements (e.g. allergy
or intolerance to any substance in the used meal replacements, veganism or
suffering from kidney failure, liver failure, cardiac insufficiency, cancer,
hypokalaemia or phenylketonuria and porphyria
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 | NL70092.081.19 |