NCT07268209Completed
Validation of a Score for Supplementation Needs of Vitamins, Micronutrients and Proteins After Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
ABSTRACT Obesity is, nowadays, a pandemic. The treatment of patients affected by obesity is very complex and requires the synergy of a multidisciplinary team that addresses the problem in its different spheres. Among the available treatment options, surgery remains the most effective in the long term. Among surgical techniques, there are different types based on different mechanisms. Among them, hypoabsorptive techniques, which are the most effective, can lead to malnutrition and vitamin deficiencies, so the creation of a standardized score -similar to Clavien-Dindo- could be a simple, reproducible tool with sufficient clinical relevance to allow comparison of nutritional outcomes between different surgical techniques. Hypothesis: The BARSCORE score will allow estimation of supplementation needs for vitamins, micronutrients and proteins after bariatric surgery. Objectives: To validate a score in bariatric surgery that grades supplementation needs by relating them to patient characteristics and the proposed surgical technique. Methodology: observational, longitudinal, multicenter study. The study sample will consist of patients who underwent bariatric surgery between January 2015 and December 2021 in participating centers (Appendix 1). Patients will be divided into three groups based on the surgery performed and the score will be applied. Subsequently, surveys will be conducted to evaluate the score and cases for applying the score. For statistical analysis, Spearman's correlation test will be used to verify the consistency of the score and a two-way ANOVA analysis to measure its concordance.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 4514 (actual)
- First submitted
- 13 Sept 2025
- Start date
- 12 Jun 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Obesity
- NCT number
- NCT07268209
What you commit to
- Study type: Observational
- Participants enrolled: 4514
- From 12 Jun 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients operated on for revisional surgery.
- Patients operated on via open approach or requiring conversion to open approach during surgery.
Other
- Patients operated with less frequent techniques such as single-anastomosis gastric bypass or intestinal bipartition.
- Patients with loss to follow-up.
Who the study is looking for
- Patients operated on for primary laparoscopic bariatric surgery using vertical gastrectomy, gastric bypass, duodenal switch, or single-anastomosis duodenal switch (SADI-S)
- Techniques between 2015 and 2022 in participating centers.
- Minimum 2-year follow-up.
- Analytical control and evaluation by endocrinologist and dietitian/nutritionist.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.