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NCT Number: NCT02124434

Laparoscopic Sleeve Gastrectomy - A Prospective Study of Weight Loss, Comorbidities and Patients' Quality of Life

Surgery is considered the best therapy for morbid obesity and its comorbidities, where alterations in lifestyle, diets and drugs have failed to achieve weight loss. The most widely performed in Israel is Laparoscopic Sleeve Gastrectomy (LSG), and several studies have reported high success rates in reducing weight and improving comorbidities common among obese patients such as hypertension; diabetes mellitus type II; dyslipidemia; osteoarthritis; obstructive sleep apnea etc.

The hypothesis of this prospective study is that the LSG is an effective treatment for achieving weight loss, for improving and even curing comorbidities and for improving the patient's QOL. Another supposition is that patient's socio-economic status can influence success rates of bariatric procedures.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, 4429900, Israel

About this study

Introduction - Morbid obesity is considered an ever growing pandemic. Most morbidly obese patients suffer from comorbidities such as hypertension; diabetes mellitus type II; dyslipidemia; osteoarthritis; obstructive sleep apnea etc. Surgery is considered the best therapy for morbid obesity and its comorbidities, where alterations in lifestyle, diets and drugs have failed to achieve weight loss. There are some procedures, some more commonly practiced than others, most of them done laparoscopically. The most widely performed in Israel is Laparoscopic Sleeve Gastrectomy (LSG), and several studies have reported high success rates in reducing weight and improving comorbidities. However, few studies exists, mostly retrospective, on the long term results after LSG. These studies have demonstrated significant weight loss, significant decrease in excessive body weight and also significant improvement in patients' quality of lives (QOL). However, a single comprehensive prospective research encompassing all three parameters was not found by us in a preliminary literature review. No studies were found regarding the effect of socio-economic status on the late results of LSG.

Goals -The goal of the present study is to prospectively follow patients undergoing LSG and to assess its effectiveness in weight loss and in the improvement of comorbidities and quality of life. We also plan to evaluate the effect of socio-economic status on the results of bariatric surgery, with emphasis on changes in QOL of these patients.

Material and Methods - In an 18 month long prospective research, a set of two questionnaires will be given to each patient undergoing LSG for morbid obesity at three time points: before surgery, 6 and 12 months post-surgery. The first questionnaire includes demographic, socio-economic and physiological data and health related questions regarding comorbidities and their methods of treatment. The second questionnaire is the Short Form 36v2, an accepted QOL questionnaire which, using 36 questions. At the end of the research, a statistical analysis of the results will be performed.

Hypothesis - The hypothesis states that the LSG is an effective treatment for achieving weight loss, for improving and even curing comorbidities and for improving the patient's QOL. Another supposition is that patient's socio-economic status can influence success rates of bariatric procedures.

Importance of the study - Several studies was done reviewing this procedure's efficacy according to physiological parameters and improvement in comorbidities and quality of life. Most of which are retrospective. A prospective research that encompasses all these three parameters was not currently found in the medical literature Keywords - Morbid Obesity, Bariatric surgery, Sleeve Gastrectomy, Quality of Life, Comorbidities, Weight loss.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 18-70

Exclusion criteria

  • patients who underwent previous bariatric surgery
  • patients unwilling to participate in the study
  • female patients who are currently pregnant
  • patients who are cognitively impaired or lacking judgement

Treatment and study plan

Primary outcomes

  1. Weight loss

    Time frame: 1 year

    Observe and record subjects' weight loos over the course of one year.

  2. Improvement in quality of life

    Time frame: 1 year

    observe and record the improvement in subjects' quality of life as reported by them in the questionnaire

Secondary outcomes

  1. Improvement in comorbidities

    Time frame: 1 year

    Observe and record improvement in five obesity related comorbidities -

    • Diabetes mellitus type 2
    • Hypertension
    • Dyslipidemia
    • Osteoarthritis
    • Obstructive sleep apnea

Other outcomes

  1. The affect of education, socioeconomic status and ethnic origin on the results of the surgery

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2014
Registry last updated
Mar 22, 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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