Validation of a Score for Supplementation Needs of Vitamins, Micronutrients and Proteins After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,514
- 试验地点
- 1
- 主要终点
- Score coherence
研究概览
简要总结
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.
详细描述
INTRODUCTION Morbid obesity is considered the great epidemic of this century. It is the leading cause of non-traumatic death in the Western population and is progressively affecting developing countries. In the latest epidemiological studies, it is estimated that in Spain more than 15% of the population is overweight, and approximately 5% suffer from morbid obesity.
The treatment of morbid obesity is multidisciplinary, ranging from changes in lifestyle habits and diet to surgery. Among all available therapeutic options, bariatric surgery is the only cost-effective long-term treatment for patients with morbid obesity. It offers better results than pharmacological treatments and lifestyle changes. Furthermore, it has been shown to reduce and improve comorbidities, improve quality of life, reduce the risk of cardiovascular diseases and mortality, and improve quality of life.
There are currently several standardized bariatric surgical techniques. These techniques can be restrictive such as vertical gastrectomy (VG), hypoabsorptive such as duodenal switch (DS) and single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), or mixed such as gastric bypass (GBP). Their indication will depend on factors such as the patient's BMI, metabolic comorbidities, or the surgical team's experience, among others. All of them have proven to be safe in experienced teams, with mortality rates equal to or less than 0.5% and morbidity less than 10%.
Although postoperative risks are low, they must be considered along with the potential benefits of surgery on an individual basis and as accurately as possible in each case. This allows the decision to perform surgery to be made consensually with the patient based on objective data.
One of the main risks, especially of mixed and hypoabsorptive techniques, is the risk of malnutrition and vitamin deficiencies. This complication is recorded in the literature in a heterogeneous and non-comparable manner. Articles documenting levels of nutrients, vitamins, and trace elements in blood during follow-up after bariatric surgery are complex to assess since data collection is not performed in a standardized way and it is not specified whether blood levels are with or without supplementation or the supplementation dose received; making them non-uniform and difficult to compare with each other.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients operated on for revisional surgery.
- •Patients operated with less frequent techniques such as single-anastomosis gastric bypass or intestinal bipartition.
- •Patients operated on via open approach or requiring conversion to open approach during surgery.
- •Patients with loss to follow-up.
结局指标
主要结局
Score coherence
时间窗: Baseline score measurement at inclusion in the study
Measure: Spearman correlation coefficient between surgical complexity and BARSCORE score (0: no supplements, I protocol, II oral supplements, III parenteral supplements, IV mild malnutrition, V severe malnutrition). Higher values of the score indicate a greater need for supplementation. Success criteria: p \<0.05
Score Concordance (reproducibility)
时间窗: Through study completion, an average of 6 months
Measure: Two-way ANOVA analysis of responses from different investigators on standardized cases. The investigators will be given a list of cases where they have to apply the BARSCORE score (0: no supplements, I protocol, II oral supplements, III parenteral supplements, IV mild malnutrition, V severe malnutrition). Success criteria: p \<0.05
Ease of Application
时间窗: Through study completion, an average of 6 months
Measure: Percentage of favorable responses in the evaluation survey Success criteria: \>70% favorable responses
次要结局
未报告次要终点
研究者
Javier Osorio
Head of Esophago-gastric and Bariatric Surgery Unit
Hospital Universitari de Bellvitge