Quality of Life 10 Years After Bariatric Surgery

Obesity Clinical Trial

— Qol-10  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190459
• Other study ID #: KBET/156/B/201
• Status: Completed
• Start date: May 1, 2009
• Est. completion date: June 1, 2019

Study information

• Verified date: December 2019
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• LSG
Bariatric surgery
• LRYGB
Bariatric surgery

Locations

Country	Name	City	State
Poland	2nd Department of General Surgery, Jagiellonian University Medical College	Cracovia

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years
Primary	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".	10 years
Secondary	Weight change		10 years