NCT02124434

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2015

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

April 6, 2014

Last Update Submit

March 21, 2018

Conditions

Obesity

Keywords

Laparoscopic Sleeve Gastrectomy surgery

Outcome Measures

Primary Outcomes (2)

  • Weight loss

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

    1 year

  • Improvement in quality of life

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

    1 year

Secondary Outcomes (1)

  • Improvement in comorbidities

    1 year

Other Outcomes (1)

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

    1 year

Study Arms (1)

Laparoscopic Sleeve Gastrectomy

Patients undergoing Laparoscopic Sleeve Gastrectomy surgery for morbid obesity

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing Laparoscopic Sleeve Gastrectomy surgery for morbid obesity.

You may qualify if:

  • age between 18-70

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 4429900, Israel

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2014

First Posted

April 28, 2014

Study Start

February 1, 2014

Primary Completion

October 30, 2015

Study Completion

October 30, 2015

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

IL(1)