Status:
UNKNOWN
Post-bariatric Surgery Weaning With Food for Special Medical Purposes to Increase Patient Compliance.
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Bariatric Surgery
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomica...
Detailed Description
Primary goal: Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable by Sensory Questionnaire. Secondary objective: * Patient complia...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤ of 60
- Subjects with severe or morbid obesity (BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2)
- Absence of diagnosis of primary obesity
- Absence of medical/psychiatric contraindications
- Signature of informed consent for the study
- Patients who are candidates by clinical practice for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
Exclusion
- Presence of chronic diseases of the digestive system, such as chronic diseases intestinal, malabsorption syndrome, diverticulosis of the colon
- Current pregnancy (verified by self-declaration) and/or lactation
- Subjects with endocrine disorders (e.g., Cushing's m., thyroid disease uncontrolled)
- Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl and eGFR \< 60 ml/min
- Presence of malignant pathology
- Alcohol or drug abuse
- Severe psychological/psychiatric disorders
- Difficulty adhering to the protocol due to language barriers or other reasons.
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 9 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06205017
Start Date
January 9 2024
End Date
August 9 2024
Last Update
January 12 2024
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