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Quality of Life 10 Years After Bariatric Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04190459
Acronym
Qol-10
Enrollment
65
Registered
2019-12-09
Start date
2009-05-01
Completion date
2019-06-01
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief 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. 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).

Interventions

PROCEDURELSG

Bariatric surgery

PROCEDURELRYGB

Bariatric surgery

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* 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).

Exclusion criteria

* previous bariatric procedures

Design outcomes

Primary

MeasureTime frameDescription
Quality of life measured as a Short Form Health Survey - 36 score.10 yearsTo 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.10 yearsTo 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 isvery good.

Secondary

MeasureTime frame
Weight change10 years

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026