The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery

Morbid Obesity Clinical Trial

Official title:

The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04433338
• Other study ID #: NL70092.081.19
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: July 2027

Study information

• Verified date: November 2023
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2027
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Other:
• 14-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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of the diet	Feasibility will be assessed via questionnaires	During the 14-day intervention period
Other	Compliance of the diet	Compliance will be assessed via food records	During the 14-day intervention period
Other	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
Other	Wound healing	Degree of wound healing post-surgery will be checked based on appearance on a 5-point Likert scale.	4 weeks
Primary	Operative time of the RYGB procedure	Duration of the surgical procedure, retrieved from the electronic medical record	surgery
Secondary	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: 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)	surgery
Secondary	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
Secondary	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