Quality of Life 10 Years After Bariatric Surgery (Qol-10)

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: LSG; Procedure: LRYGB

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Poland
  • Cracovia, Poland
    • 2nd Department of General Surgery, Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LSG; laparoscopic sleeve gastrectomy	Procedure: LSG; Bariatric surgery
LRYGB; laparoscopic Roux-en-Y gastric bypass	Procedure: LRYGB; Bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Weight change	10 years

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KBET/156/B/201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No