Nutritional Health and Satisfaction After Bariatric Surgery: a Five-Year Retrospective Study

October 28, 2024 updated by: Mauro Lombardo, San Raffaele Telematic University

Enhancing Nutritional Health and Patient Satisfaction Five Years After Metabolic Bariatric Surgery with Targeted Supplementation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-Metabolic Bariatric Surgery Patients
A cohort of 249 patients who underwent metabolic bariatric surgery, including various procedures such as Laparoscopic Sleeve Gastrectomy (LSG) and Roux-en-Y Gastric Bypass (RYGB), with follow-up on long-term outcomes related to weight maintenance, nutritional deficiencies, and patient satisfaction
Other: Metabolic Bariatric Surgery Procedures
Observational analysis of various metabolic bariatric surgeries, including LSG, RYGB, and OAGB, focusing on long-term outcomes related to weight maintenance, nutritional health, and patient satisfaction.
Other Names:
  • nutrition
  • weight
  • bariatric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Excess Weight Loss (%EWL)
Time Frame: The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.
5 years post-surgery
The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Nutritional Deficiencies
Time Frame: 5 years post-surgery
Rate of nutritional deficiencies, specifically in iron, vitamin D, and vitamin B12, following metabolic bariatric surgery, with a focus on patients receiving targeted supplementation.
5 years post-surgery
Patient Satisfaction and Quality of Life
Time Frame: 5 years post-surgery
Self-reported patient satisfaction and quality of life improvement post-surgery, assessed through a custom survey.
5 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Raffaele Telematic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100/SR/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy concerns and the retrospective nature of the study, which limits consent for data sharing beyond the initial research purposes. Aggregated study results and relevant findings are available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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