Bariatric Surgery, Morbid Obesity
Conditions
Keywords
Bariatric surgery, Morbid Obesity, Weight Loss, Diet, RYGB
Brief summary
Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are still conflicting. This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.
Interventions
OTHER14-day Low Calorie Diet
Participants will be asked to: * Use 4 (women) or 5 (men) Modifast meal replacements per day. * Daily consume a minimum of 250 grams of (raw) vegetables without dressing. * Daily consume 100 grams of lean meat/fish/meat analogues. * Daily consume two spoons of liquid oil * Daily drink at least 2.0 litres of water, coffee or tea without added sugar or milk, bouillon or sugar-free drinks.
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon) * Able to prepare the meal replacements at home
Exclusion criteria
* Undergoing another bariatric procedure than primary RYGB. * Diabetes Mellitus * Contraindication for the usage of Modifast meal replacements: * Allergy or intolerance to any substance in the used meal replacements (Soy, milk, gluten, egg, peanuts, nuts and seeds) * Veganism * Kidney failure (GFR \< 90 ml/min/1.73m2), liver failure or cardiac insufficiency * A heart attack (myocardial infarct) in the past twelve months * Cancer * Hypokalaemia: serum potassium level \<3.4 mmol/l * Phenylketonuria & Porphyria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time of the RYGB procedure | surgery | Duration of the surgical procedure, retrieved from the electronic medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of the RYGB procedure | surgery | Ten aspects of the RYGB procedure will be scored on a 5-point Likert scale. The total score can range from 10 to 50, with 10 being the easiest. The ten aspects include: * Exerting force on instruments (1=very low, 5= very high) * Difficulty of moving the liver (1=very easy, 5=very difficult) * Size of the liver (1=very small, 5= very large) * Size of omentum (1=very small, 5= very large) * Difficulty of approaching pouch (1=very easy, 5=very difficult) * Accessibility of Treitz ligament (1=very easy, 5=very difficult) * Difficulty of creating pouch (1=very easy, 5=very difficult) * Difficulty of measuring small intestine (1=very easy, 5=very difficult) * Difficulty of entero-entero connection (1=very easy, 5=very difficult) * Difficulty of abdominal wall hernia repair (1=very easy, 5=very difficult) |
| Appearance of the patient's liver | surgery | Includes four images of the liver in different stages (1= healthy, 2= fatty liver, 3= fatty liver with inflammation, 4= liver cirrhosis). Surgeons will be asked to choose the image that best matches the appearance of the patient's liver. |
| Post-operative weight loss | 4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery | Body weight measurements to assess weight loss after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the diet | During the 14-day intervention period | Feasibility will be assessed via questionnaires |
| Compliance of the diet | During the 14-day intervention period | Compliance will be assessed via food records |
| Complication rate | First 30 days post-surgery | All short term complications during the first 30 days will be recorded and classified according to the Clavien-Dindo classification |
| Wound healing | 4 weeks | Degree of wound healing post-surgery will be checked based on appearance on a 5-point Likert scale. |
Countries
Netherlands
Outcome results
None listed