Bariatric SurgeriesNCT03467581
Five-year Outcome of Laparoscopic Gastric Sleeve
An observational study of Bariatric Surgeries and Metabolic Surgery, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgeries, Metabolic Surgery
- How many people
- 500 participants
- Where
- 1 siteEstonia
- Study dates
- 8 Oct 2008to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital.
Who may be able to join
- The criteria for bariatric surgery: BMI of >40, or >35 with certain obesity related comorbidities
Who cannot join
- Patients who did not fill the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Toomas Sillakivi, Dr, PhD contact
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, 50406
Eva-Maria Kikkas, Dr, +37258162720, evamariakikkas@gmail.com
Toomas Sillakivi, Dr, PhD, toomas.sillakivi@kliinikum.ee
About this study
Official title: Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.
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.
Read the 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.
- Conditions
- Bariatric Surgeries, Metabolic Surgery
- Keywords
- gastric sleeve
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year outcome of laparoscopic gastric sleeve
5-year outcome in terms of weight loss, calculated in mean excess weight lost (%EWL).
Measured: 5-year follow-up
Secondary outcomes (2)
Five-year outcome of laparoscopic gastric sleeve
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.
Measured: 5-year follow-up
Five-year outcome of laparoscopic gastric sleeve
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.
Measured: 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start8 Oct 2008
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva-Maria Kikkas, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467581
- Sponsor's protocol ID
- Sleeve5years
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.
- ClinicalTrials.gov ID
- NCT03467581
- Acronym / sponsor ID
- Sleeve5years
- Conditions
- Bariatric Surgeries, Metabolic Surgery
- Keywords
- gastric sleeve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- 8 Oct 2008 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital.
Key inclusion criteria (1 listed)
- The criteria for bariatric surgery: BMI of >40, or >35 with certain obesity related comorbidities
Key exclusion criteria (1 listed)
- Patients who did not fill the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Five-year outcome of laparoscopic gastric sleeve
Time frame: 5-year follow-up
Five-year outcome of laparoscopic gastric sleeve
Time frame: 5-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgeries
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Toomas Sillakivi, Dr, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgeries and Metabolic Surgery, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toomas Sillakivi, Dr, PhD (toomas.sillakivi@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year outcome of laparoscopic gastric sleeve (time frame: 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.