Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT04190459
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2019-11-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life 10 Years After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life measured as a Short Form Health Survey - 36 score.', 'timeFrame': '10 years', 'description': '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.'}, {'measure': 'Quality of life measured as a Moorehead-Ardelt Quality of Life Questionnaire II score.', 'timeFrame': '10 years', 'description': '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".'}], 'secondaryOutcomes': [{'measure': 'Weight change', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: The investigators aim to analyze the bariatric surgery effect on the long term QoL, considering the type of surgery.\n\nDesign: 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.\n\nMain 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent to participate in the study\n* meeting the eligibility criteria for bariatric treatment, either for laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB).\n\nExclusion Criteria:\n\n* previous bariatric procedures'}, 'identificationModule': {'nctId': 'NCT04190459', 'acronym': 'Qol-10', 'briefTitle': 'Quality of Life 10 Years After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'orgStudyIdInfo': {'id': 'KBET/156/B/201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LSG', 'description': 'laparoscopic sleeve gastrectomy', 'interventionNames': ['Procedure: LSG']}, {'label': 'LRYGB', 'description': 'laparoscopic Roux-en-Y gastric bypass', 'interventionNames': ['Procedure: LRYGB']}], 'interventions': [{'name': 'LSG', 'type': 'PROCEDURE', 'description': 'Bariatric surgery', 'armGroupLabels': ['LSG']}, {'name': 'LRYGB', 'type': 'PROCEDURE', 'description': 'Bariatric surgery', 'armGroupLabels': ['LRYGB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'country': 'Poland', 'facility': '2nd Department of General Surgery, Jagiellonian University Medical College', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor', 'investigatorFullName': 'Tomasz Stefura', 'investigatorAffiliation': 'Jagiellonian University'}}}}