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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will follow a low-calorie diet during 14 days before undergoing surgery. The diet will consist of both meal replacements and regular foods. For women, the diet provides ± 900 kcal, 50 grams of carbohydrates, 85 grams of protein, 30 grams of fat and 25 grams of fibres. For men, the diet provides ± 1000 kcal, 55 grams of carbohydrates, 100 grams of protein, 30 grams of fat and 30 grams of fibres. |
|
| Control group | No Intervention | Participants in the control group can eat according to the standard nutritional advices provided by their dietitian. These advices are intended to educate participants on the recommended eating pattern after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14-day Low Calorie Diet | Other | Participants will be asked to:
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time of the RYGB procedure | Duration of the surgical procedure, retrieved from the electronic medical record | surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of the RYGB procedure | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the diet | Feasibility will be assessed via questionnaires | During the 14-day intervention period |
| Compliance of the diet | Compliance will be assessed via food records |
Inclusion Criteria:
Exclusion Criteria:
Undergoing another bariatric procedure than primary RYGB.
Diabetes Mellitus
Contraindication for the usage of Modifast meal replacements:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J Hazebroek, MD, PhD | Vitalys, part of Rijnstate hospital/Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6811AD | Netherlands |
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|
| surgery |
| Appearance of the patient's liver | 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. | surgery |
| Post-operative weight loss | Body weight measurements to assess weight loss after surgery | 4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery |
| During the 14-day intervention period |
| Complication rate | All short term complications during the first 30 days will be recorded and classified according to the Clavien-Dindo classification | First 30 days post-surgery |
| Wound healing | Degree of wound healing post-surgery will be checked based on appearance on a 5-point Likert scale. | 4 weeks |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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