Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery

Refill France

Status: Completed

Conditions: Bariatric Surgery; Obesity

Treatments: Dietary Supplement: Refill Bypass

Study type: Observational

Funder types: Industry

Identifiers

NCT02440087

Refill

Details and patient eligibility

About

This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months.

This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery.

Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon.

The main objective is to evaluate the efficacy of the dietary supplement Refill.

The primary endpoint is the reduction of iron deficiency.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with a scheduled bariatric surgery "gastric bypass",
• Patient who performed a blood test before surgery,
• Patient compliant.

Exclusion criteria

• Allergy to components of the dietary supplement,
• Pregnancy or breastfeeding,
• Any biological abnormality considered by the investigator significant.