Back to resultsThe PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
Primary Purpose
Bariatric Surgery, Morbid Obesity
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
14-day Low Calorie Diet
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery focused on measuring Bariatric surgery, Morbid Obesity, Weight Loss, Diet, RYGB
Eligibility Criteria
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
Sites / Locations
- Rijnstate Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Operative time of the RYGB procedure
Duration of the surgical procedure, retrieved from the electronic medical record
Secondary Outcome Measures
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)
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.
Post-operative weight loss
Body weight measurements to assess weight loss after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04433338
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Morbid Obesity
Keywords
Bariatric surgery, Morbid Obesity, Weight Loss, Diet, RYGB
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
14-day Low Calorie Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Operative time of the RYGB procedure
Description
Duration of the surgical procedure, retrieved from the electronic medical record
Time Frame
surgery
Secondary Outcome Measure Information:
Title
Ease of the RYGB procedure
Description
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)
Time Frame
surgery
Title
Appearance of the patient's liver
Description
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.
Time Frame
surgery
Title
Post-operative weight loss
Description
Body weight measurements to assess weight loss after surgery
Time Frame
4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery
Other Pre-specified Outcome Measures:
Title
Feasibility of the diet
Description
Feasibility will be assessed via questionnaires
Time Frame
During the 14-day intervention period
Title
Compliance of the diet
Description
Compliance will be assessed via food records
Time Frame
During the 14-day intervention period
Title
Complication rate
Description
All short term complications during the first 30 days will be recorded and classified according to the Clavien-Dindo classification
Time Frame
First 30 days post-surgery
Title
Wound healing
Description
Degree of wound healing post-surgery will be checked based on appearance on a 5-point Likert scale.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Hazebroek, MD, PhD
Organizational Affiliation
Vitalys, part of Rijnstate hospital/Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6811AD
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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