Quality of Life 10 Years After Bariatric Surgery

NCT ID: NCT04190459

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-01

Study Completion Date

2019-06-01

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LSG

laparoscopic sleeve gastrectomy

LSG

Intervention Type PROCEDURE

Bariatric surgery

LRYGB

laparoscopic Roux-en-Y gastric bypass

LRYGB

Intervention Type PROCEDURE

Bariatric surgery

Interventions

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LSG

Bariatric surgery

Intervention Type PROCEDURE

LRYGB

Bariatric surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Stefura

Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, , Poland

Site Status

Countries

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Poland

Other Identifiers

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KBET/156/B/201

Identifier Type: -

Identifier Source: org_study_id