Effect of preoperative weight loss with a 14-day low-calorie diet on surgical procedure and outcomes in patients undergoing RYGB surgery.
- Conditions
- Morbide obesitasbariatric surgeryweight loss surgery10017998
- Registration Number
- NL-OMON49715
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study outcome is the difference in operative time of the RYGB<br /><br>procedure between the intervention and control group, retrieved from electronic<br /><br>medical records after surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The first secondary outcome is the difference in (perceived) ease of the<br /><br>RYGB procedure between the intervention and control group, assessed by a<br /><br>surgery score sheet. This surgery score sheet was constructed in cooperation<br /><br>with surgeons and is based on the subsequent steps of the RYGB procedure.<br /><br><br /><br>2. The second secondary outcome is the difference in postoperative weight loss<br /><br>between the intervention and control group, assessed by body weight<br /><br>measurements during regular follow-up visits.<br /><br><br /><br>The tertiary outcome of this study is the feasibility, compliance and safety of<br /><br>the diet. We will asses if the diet can be implemented in the standard<br /><br>nutritional care procedure for bariatric patients at Vitalys. Opinion of both<br /><br>patients and dietitians will be taken into account. Besides, short term<br /><br>complication rates and degree of wound healing will be used as an indication<br /><br>for safety.</p><br>