ObesityQol-10NCT04190459
Quality of Life 10 Years After Bariatric Surgery
An observational study of Obesity, run by Jagiellonian University at 1 site in Poland.
Trial summary
Importance: Improvement of the QoL after bariatric surgery is an important outcome of the treatment. The investigators believe that assessment of distant QoL results, could provide new insight into effectiveness of most popular bariatric procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- LSG and LRYGB
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2009to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Initially the investigators included 65 patients undergoing surgical treatment for morbid obesity [39 females (60%) and 26 males (40%)]. Mean age was 42.75 years. Overall, 34 patients underwent LSG (52.3%) and 31 patients underwent LRYGB (47.7%). Mean initial body weight was 146.2 kg, mean BMI before surgery was 50.44 kg/m2.
Who may be able to join
- informed consent to participate in the study
- meeting the eligibility criteria for bariatric treatment, either for laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB).
Who cannot join
- previous bariatric procedures
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Department of General Surgery, Jagiellonian University Medical College
Krakow
About this study
Importance: Improvement of the QoL after bariatric surgery is an important outcome of the treatment. The investigators believe that assessment of distant QoL results, could provide new insight into effectiveness of most popular bariatric procedures.
Objective: The investigators aim to analyze the bariatric surgery effect on the long term QoL, considering the type of surgery.
Read more
Design: A cohort study including patients undergoing bariatric surgery. Setting: One academic referral center. Exposures: Patients undergo Laparoscopic Sleeve Gastrectomy or Laparoscopic Roux-en-Y Gastric Bypass . Surgical technique is standardized and consistent in the whole study group.
Main Outcomes and Measures: The main outcome is the change of QoL after bariatric surgery. It is assessed in three different time points: pre-surgery, first follow up (1 year after surgery) and second follow-up (10 years after surgery). The investigators use two licensed and standardized questionnaires: (Short Form Health Survey) and MA-QoLQII (Moorehead-Ardelt Quality of Life Questionnaire II).
- Conditions
- Obesity
- Being tested
- LSG, LRYGB
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSGProcedure or surgery
Bariatric surgery
LRYGBProcedure or surgery
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| LSG | laparoscopic sleeve gastrectomy Receives: Procedure: LSG | |
| LRYGB | laparoscopic Roux-en-Y gastric bypass Receives: Procedure: LRYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured as a Short Form Health Survey - 36 score.
To assess the quality of life of included patients the investigators used licensed and standardized questionnaire, which is designed for medical purposes: SF-36 (Short Form Health Survey). It is scale with minimal value being 0 and maximal value being 100 scale. Higher score means better outcome.
Measured: 10 years
Quality of life measured as a Moorehead-Ardelt Quality of Life Questionnaire II score.
To assess the quality of life of included patients the investigators used licensed and standardized questionnaire, which is designed for medical purposes: MA-QoLQII (Moorehead-Ardelt Quality of Life Questionnaire II). The MA-QoLQII questionnaire has six dimensions. The MA II questionnaire is used as a part of the Bariatric Analysis and Reporting Outcome System (BAROS) and assesses the patients subjective impression of quality of life in the areas of general self-esteem, physical activity, social contacts, satisfaction concerning work, pleasure related to sexuality and focus on eating behavior. Each item is scored from-0.5 to +0.5. The total score consists of the sum of the six dimensions with a range of -3 to +3. A total score of 1.1 to 2 is considered "good", above 2.1 is"very good".
Measured: 10 years
Secondary outcomes (1)
Weight change
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 May 2009
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Stefura, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190459
- Sponsor's protocol ID
- KBET/156/B/201
- Acronym
- Qol-10
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 9 Dec 2019
- 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 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life 10 Years After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04190459
- Acronym / sponsor ID
- Qol-10 / KBET/156/B/201
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 May 2009 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Dec 2019 (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.
Importance: Improvement of the QoL after bariatric surgery is an important outcome of the treatment. The investigators believe that assessment of distant QoL results, could provide new insight into effectiveness of most popular bariatric procedures.
Objective: The investigators aim to analyze the bariatric surgery effect on the long term QoL, considering the type of surgery.
Design: A cohort study including patients undergoing bariatric surgery. Setting: One academic referral center. Exposures: Patients undergo Laparoscopic Sleeve Gastrectomy or Laparoscopic Roux-en-Y Gastric Bypass . Surgical technique is standardized and consistent in the whole study group.
Main Outcomes and Measures: The main outcome is the change of QoL after bariatric surgery. It is assessed in three different time points: pre-surgery, first follow up (1 year after surgery) and second follow-up (10 years after surgery). The investigators use two licensed and standardized questionnaires: (Short Form Health Survey) and MA-QoLQII (Moorehead-Ardelt Quality of Life Questionnaire II).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG | – | Procedure: LSGlaparoscopic sleeve gastrectomy |
| LRYGB | – | Procedure: LRYGBlaparoscopic Roux-en-Y gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Initially the investigators included 65 patients undergoing surgical treatment for morbid obesity [39 females (60%) and 26 males (40%)]. Mean age was 42.75 years. Overall, 34 patients underwent LSG (52.3%) and 31 patients underwent LRYGB (47.7%). Mean initial body weight was 146.2 kg, mean BMI before surgery was 50.44 kg/m2.
Key inclusion criteria (2 listed)
- informed consent to participate in the study
- meeting the eligibility criteria for bariatric treatment, either for laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB).
Key exclusion criteria (1 listed)
- previous bariatric procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSGBariatric surgery | Procedure or surgery | LSG |
| LRYGBBariatric surgery | Procedure or surgery | LRYGB |
Primary outcome
Quality of life measured as a Short Form Health Survey - 36 score.
Time frame: 10 years
To assess the quality of life of included patients the investigators used licensed and standardized questionnaire, which is designed for medical purposes: SF-36 (Short Form Health Survey). It is scale with minimal value being 0 and maximal value being 100 scale. Higher score means better outcome.
Quality of life measured as a Moorehead-Ardelt Quality of Life Questionnaire II score.
Time frame: 10 years
To assess the quality of life of included patients the investigators used licensed and standardized questionnaire, which is designed for medical purposes: MA-QoLQII (Moorehead-Ardelt Quality of Life Questionnaire II). The MA-QoLQII questionnaire has six dimensions. The MA II questionnaire is used as a part of the Bariatric Analysis and Reporting Outcome System (BAROS) and assesses the patients subjective impression of quality of life in the areas of general self-esteem, physical activity, social contacts, satisfaction concerning work, pleasure related to sexuality and focus on eating behavior. Each item is scored from-0.5 to +0.5. The total score consists of the sum of the six dimensions with a range of -3 to +3. A total score of 1.1 to 2 is considered "good", above 2.1 is"very good".
1 secondary outcome
Weight change
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity, run by Jagiellonian University at 1 site in Poland.
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 2 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: finished, as of the sponsor's last update on 9 Dec 2019. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured as a Short Form Health Survey - 36 score. (time frame: 10 years). The study lists 2 primary outcomes in all. 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 9 Dec 2019.