Effect of preoperative weight loss with a 14-day low-calorie diet on surgical procedure and outcomes in patients undergoing RYGB surgery.

Effect of preoperative weight loss with a 14-day low-calorie diet on surgical procedure and outcomes in patients undergoing RYGB surgery. - PREBA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49715

Enrollment

Registered

2019-11-05

Start date

2020-09-29

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbide obesitas bariatric surgery weight loss surgery

Interventions

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 s

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)