Clinical trial NCT06664580: Nutritional Health and Satisfaction After Bariatric Surgery: a Five-Year Retrospective Study
Official title: Enhancing Nutritional Health and Patient Satisfaction Five Years After Metabolic Bariatric Surgery with Targeted Supplementation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity and Overweight
Nutritional Deficiency
Bariatric Surgery
Keywords: Metabolic Bariatric Surgery
Laparoscopic Sleeve Gastrectomy
Roux-en-Y Gastric Bypass
Excess Weight Loss
Iron Deficiency
Vitamin D Deficiency
Quality of Life Post-Surgery
Targeted Supplementation
Lead sponsor: San Raffaele Telematic University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who underwent metabolic bariatric surgery, including LSG and RYGB, at a specialized center, with a focus on long-term outcomes in weight maintenance, nutritional health, and patient satisfaction

Brief summary: A retrospective study analyzing long-term outcomes of metabolic bariatric surgery (MBS) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. This study evaluates outcomes for different surgical procedures, including Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB), and other MBS techniques. The findings aim to provide insight into optimal nutritional management and patient care following bariatric surgery.

Detailed description: This study retrospectively examines 249 patients who underwent metabolic bariatric surgery at a specialized center between 2012 and 2017. It evaluates long-term outcomes including weight loss, excess weight loss percentage (%EWL), and nutritional deficiencies, with a specific focus on the effectiveness of targeted supplementation protocols to improve nutritional health post-surgery. The study analyzes different surgical procedures, including LSG, RYGB, and others, comparing primary and revision surgeries. Nutritional deficiencies in essential vitamins and minerals are assessed, highlighting the need for individualized supplementation based on the type of surgery and patient adherence.

Key objectives include:

1. Assessing long-term weight loss and maintenance across different MBS procedures.
2. Identifying the prevalence of nutritional deficiencies, particularly for iron, vitamin D, and B12.
3. Evaluating patient satisfaction and quality of life improvements following MBS.

Data were collected from electronic clinical records and include anthropometric data, biochemical markers, and self-reported supplement use. Findings emphasize the importance of targeted supplementation and regular monitoring to address persistent deficiencies. The study contributes to understanding optimal long-term care strategies for MBS patients and underscores the importance of personalized nutritional support post-surgery.

Eligibility criteria: Inclusion criteria: Patients aged 18 to 65 years who underwent metabolic bariatric surgery (MBS) at the Specialized Bariatric Center between 2012 and 2017, with a follow-up period of at least five years post-surgery.

Exclusion criteria: Individuals with a history of alcoholism, severe social anxiety impacting post-operative care participation, recent neoplastic disease diagnoses, neurocognitive disorders, or other systemic diseases potentially affecting quality of life and long-term outcomes.

Primary outcomes:
measure: Percentage of Excess Weight Loss (%EWL)
timeFrame: The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.
Secondary outcomes:
measure: Incidence of Nutritional Deficiencies
timeFrame: 5 years post-surgery
measure: Patient Satisfaction and Quality of Life
timeFrame: 5 years post-surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Heusschen L, Berendsen AAM, Deden LN, Hazebroek EJ, Aarts EO. Nutritional Deficiencies 3 Years After Sleeve Gastrectomy Can Be Limited by a Specialized Multivitamin Supplement. Obes Surg. 2022 Nov;32(11):3561-3570. doi: 10.1007/s11695-022-06256-w. Epub 2022 Aug 26.
citation: Noria SF, Shelby RD, Atkins KD, Nguyen NT, Gadde KM. Weight Regain After Bariatric Surgery: Scope of the Problem, Causes, Prevention, and Treatment. Curr Diab Rep. 2023 Mar;23(3):31-42. doi: 10.1007/s11892-023-01498-z. Epub 2023 Feb 8.