Validation of a Score for Supplementation Needs of Vitamins, Micronutrients and Proteins After Bariatric Surgery

NCT07268209 | Completed

• 1 other identifier: HUB-CIR-BARSCORE
• Study Type: observational
• Target: 4,514
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity &Amp; Overweight; Bariatric Surgery; Bariatric Surgery Complication

Keywords

Bariatric surgery; Nutritional supplementation; Vitamin deficiency; Clinical score validation

Outcome Measures

Primary Outcomes (3)

• Score coherence

  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

  Baseline score measurement at inclusion in the study

• Score Concordance (reproducibility)

  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

  Through study completion, an average of 6 months

• Ease of Application

  Measure: Percentage of favorable responses in the evaluation survey Success criteria: \>70% favorable responses

  Through study completion, an average of 6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing primary minimally invasive bariatric surgery from the population area of all participating centers, between 18 and 65 years of age, in the period from January 2015 to July 2022.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge - IDIBELL: collaborator
• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (8)

• Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med. 2015 Jan 6;162(1):55-63. doi: 10.7326/M14-0697.

  PMID: 25560714 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Guilbert L, Joo P, Ortiz C, Sepulveda E, Alabi F, Leon A, Pina T, Zerrweck C. Safety and efficacy of bariatric surgery in Mexico: A detailed analysis of 500 surgeries performed at a high-volume center. Rev Gastroenterol Mex (Engl Ed). 2019 Jul-Sep;84(3):296-302. doi: 10.1016/j.rgmx.2018.05.002. Epub 2018 Jun 20. English, Spanish.

  PMID: 29933896 BACKGROUND

• Anderin C, Gustafsson UO, Heijbel N, Thorell A. Weight loss before bariatric surgery and postoperative complications: data from the Scandinavian Obesity Registry (SOReg). Ann Surg. 2015 May;261(5):909-13. doi: 10.1097/SLA.0000000000000839.

  PMID: 25211265 BACKGROUND

• Goitein D, Raziel A, Szold A, Sakran N. Assessment of perioperative complications following primary bariatric surgery according to the Clavien-Dindo classification: comparison of sleeve gastrectomy and Roux-Y gastric bypass. Surg Endosc. 2016 Jan;30(1):273-8. doi: 10.1007/s00464-015-4205-y. Epub 2015 Apr 11.

  PMID: 25861906 BACKGROUND

• Zhang L, Tan WH, Chang R, Eagon JC. Perioperative risk and complications of revisional bariatric surgery compared to primary Roux-en-Y gastric bypass. Surg Endosc. 2015 Jun;29(6):1316-20. doi: 10.1007/s00464-014-3848-4. Epub 2014 Oct 8.

  PMID: 25294534 BACKGROUND

• Grigaites, Alejandro L., et al. Morbimortalidad posoperatoria en cirugía bariátrica laparoscópica: experiencia en 1020 pacientes. Revista argentina de cirugía. 2014;106(2):1-10.

  BACKGROUND

• Rubio, Miguel A., et al. Documento de consenso sobre cirugía bariátrica. Rev Esp Obes. 2004;4(7).

  BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Avitaminosis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Deficiency Diseases; Malnutrition

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Esophago-gastric and Bariatric Surgery Unit

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: December 5, 2025
• Study Start: June 12, 2024
• Primary Completion: March 31, 2025
• Study Completion: September 13, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)