Quality of Life 10 Years After Bariatric Surgery

Completed

• Conditions: Obesity
• Interventions: Procedure: LSG; Procedure: LRYGB

• Registration Number: NCT04190459
• Lead Sponsor: Jagiellonian University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Study First Submitted: 2019-11-27
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-05
• Last Update Submitted: 2019-12-05
• Study First Posted: 2019-12-09
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LSG	LSG	laparoscopic sleeve gastrectomy
LRYGB	LRYGB	laparoscopic Roux-en-Y gastric bypass

Primary Outcome Measures

Name	Time	Method
Quality of life measured as a Moorehead-Ardelt Quality of Life Questionnaire II score.	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".
Quality of life measured as a Short Form Health Survey - 36 score.	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.

Secondary Outcome Measures

Name	Time	Method
Weight change	10 years

Trial Locations

Locations (1)

2nd Department of General Surgery, Jagiellonian University Medical College; 🇵🇱 Cracovia, Poland