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Five-year Outcome of Laparoscopic Gastric Sleeve

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ClinicalTrials.gov Identifier: NCT03467581
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Eva-Maria Kikkas, Tartu University Hospital

Tracking Information
First Submitted Date March 5, 2018
First Posted Date March 16, 2018
Last Update Posted Date March 16, 2018
Actual Study Start Date October 8, 2008
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2018)		 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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 9, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Five-year Outcome of Laparoscopic Gastric Sleeve
Official Title Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital.
Condition
  • Bariatric Surgeries
  • Metabolic Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 9, 2018)		 500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2028
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Toomas Sillakivi, Dr, PhD toomas.sillakivi@kliinikum.ee
Listed Location Countries Estonia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03467581
Other Study ID Numbers Sleeve5years
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Eva-Maria Kikkas, Tartu University Hospital
Original Responsible Party Same as current
Current Study Sponsor Tartu University Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Tartu University Hospital
Verification Date March 2018