Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04844320
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2021-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed to include 3 groups of 30 patients and a total of 90 patients. 90 patients who underwent laparoscopic sleeve gastrectomy will be divided into 3 groups according to their postoperative weight gain. The first group will include patients who have lost more than 50% EWL postoperative weight, the second group will include patients who have lost 50 to 25% EWL postoperative , and the third group will include patients who have lost less than 25% EWL postoperative.\n\nPatients in these 3 groups will be randomized on www.randomisor.org. In these 3 groups, cobb angle measurements will be made on the PA chest radiographs taken at the preoperative, postoperative 1st year and postoperative 2nd year controls. Patient satisfaction questionnaires will be conducted to compare pre- and postoperative complaints such as low back pain, back pain, and neck pain in all patients. The change in cobb angles will be determined according to the weight loss ratio (% EWL) of the patients.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-10', 'studyFirstSubmitDate': '2021-04-10', 'studyFirstSubmitQcDate': '2021-04-10', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cobb angle measurements', 'timeFrame': '2 years', 'description': 'Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.'}], 'secondaryOutcomes': [{'measure': '% EWL measurements', 'timeFrame': '2 years', 'description': '% EWL measurements will be made in all patients 1 and 2 years after laparoscopic sleeve gastrectomy'}, {'measure': 'Patient satisfaction', 'timeFrame': '2 years', 'description': 'All patients will be given a patient satisfaction questionnaire, which includes the complaints of low back pain, back pain and neck pain, and compares the postoperative and pre-operative processes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'cobb angle', 'laparoscopic sleeve gastrectomy', 'scoliosis'], 'conditions': ['Obesity, Morbid', 'Back Pain', 'Scoliosis']}, 'descriptionModule': {'briefSummary': 'Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress.\n\nThe aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.', 'detailedDescription': '90 morbidly obese patients who underwent Laparoscopic Sleeve Gastrectomy were included in the study. Cobb angle measurements were made by a radiologist included in the study from the PA chest radiographs of the operated patients in the preoperative period and in the first postoperative year, and they were recorded in a previously prepared database. In addition, in the preoperative period and postoperative first year evaluations of the patients; Patient satisfaction questionnaire in terms of low back pain, back pain, neck pain, and the value in% EWL of weight given after surgery were also recorded in the database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18.\n* Patients with a diagnosis of morbid obesity, body mass index\\> 40\n\nExclusion Criteria:\n\n* Patients who have undergone previous vertebral surgery due to any disease\n* Patients hospitalized for more than 10 days due to postoperative complications'}, 'identificationModule': {'nctId': 'NCT04844320', 'briefTitle': 'THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS', 'orgStudyIdInfo': {'id': 'DR. ANIL ERGIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '> 50 %EWL', 'description': 'Postoperative weight loss in first year \\> 50 % EWL', 'interventionNames': ['Diagnostic Test: Cobb angle measurements']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50 - 25 % EWL', 'description': 'Postoperative weight loss in first year 25 - 50 % EWL', 'interventionNames': ['Diagnostic Test: Cobb angle measurements']}, {'type': 'ACTIVE_COMPARATOR', 'label': '< 25 % EWL', 'description': 'Postoperative weight loss in first year \\< 25 % EWL', 'interventionNames': ['Diagnostic Test: Cobb angle measurements']}], 'interventions': [{'name': 'Cobb angle measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year', 'armGroupLabels': ['50 - 25 % EWL', '< 25 % EWL', '> 50 %EWL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34734', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Anıl Ergin', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Anil Ergin', 'investigatorFullName': 'ANIL ERGIN', 'investigatorAffiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}}}}