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NCT Number: NCT03467581

Five-year Outcome of Laparoscopic Gastric Sleeve

The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as the risk factors associated with postoperative nutritional deficiencies.

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Key information

Conditions

Bariatric Surgeries Metabolic Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The consecutive patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital are followed prospectively in cohort study. The outpatient hospital follow-up visits are conducted at 3 months, 1 year and 5 years postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The criteria for bariatric surgery: BMI of >40, or >35 with certain obesity related comorbidities

Exclusion criteria

  • Patients who did not fill the inclusion criteria

Treatment and study plan

Primary outcomes

  1. Five-year outcome of laparoscopic gastric sleeve

    Time frame: 5-year follow-up

    5-year outcome in terms of weight loss, calculated in mean excess weight lost (%EWL).

Secondary outcomes

  1. Five-year outcome of laparoscopic gastric sleeve

    Time frame: 5-year follow-up

    5-year outcome of resolution of obesity-related comorbidities (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, dyslipidemia). Prevalence of comorbidities are presented in percentages. McNemar´s test is employed to analyse significance of resolution of comorbidities.

  2. Five-year outcome of laparoscopic gastric sleeve

    Time frame: 5-year follow-up

    5-year risk for cumulative nutritional deficiencies. According to blood analysis results and patient provided information about taking supplementations (eg vitamine B12 or iron), prevalence of nutritional deficiencies are calculated in percetanges. Backward stepwise logistic regression is used to evaluate the risk factors for nutrition.

Study contacts

Contact information is provided by the study sponsor or research team.

Toomas Sillakivi, Dr, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Official study title

Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.

Important dates

Study start
2008
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2018
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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