Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06859320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thyroid function tests', 'timeFrame': 'from one day to one year after surgery', 'description': 'TSH,T3,T4 are measured pre and post operative'}, {'measure': 'depression', 'timeFrame': 'from one day to one year after surgery', 'description': 'depression status is compared pre-operative and post-operative using depression questionnaire (PHQ-9)( patient health questionnaire-9)'}, {'measure': 'weight', 'timeFrame': 'from one day to one year after surgery', 'description': 'weight of the patient will be measured in Kg using weight scale'}, {'measure': 'dose of thyroid replacement therapy', 'timeFrame': 'monthly from one day to one year post surgery.', 'description': 'the dose of L-thyroxin is monitored in microgrames'}, {'measure': 'gasteric leakage', 'timeFrame': 'from one day to 1 week post-surgery', 'description': 'leakage after surgery from staple line measured in ml in the drain'}, {'measure': 'wound infection', 'timeFrame': 'from one day to 2 weeks post-surgery', 'description': 'wound infection will be identified by pus in the drain or in the wound'}], 'secondaryOutcomes': [{'measure': 'age', 'timeFrame': '2 days pre-operative', 'description': 'age will be measured in years'}, {'measure': 'sex', 'timeFrame': '2 days pre-operative', 'description': 'sex of patient (male or female) will be recorded before surgery'}, {'measure': 'BMI ( Body Mass Index)', 'timeFrame': '2 days before surgery to one year after surgery', 'description': 'BMI is measured by the sum of weight in kg divided by the squared height in meters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'hypothyroidism', 'Depression'], 'conditions': ['Obesity and Obesity-related Medical Conditions']}, 'descriptionModule': {'briefSummary': 'Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese patients with depression and hypothyroidism controlled by medical treatment candidate for sleeve gastrectomy\n\nExclusion Criteria:\n\n* patients less than 18 or above 60\n* other psychiatric or medical disorders.\n* patients not fit for surgery\n* un controlled patients'}, 'identificationModule': {'nctId': 'NCT06859320', 'briefTitle': 'Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression', 'orgStudyIdInfo': {'id': '#1108\\25-Feb-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'morbid obesity and overweight in patients with hypothyroidism and depression', 'interventionNames': ['Procedure: laparoscopic sleeve gastrectomy']}], 'interventions': [{'name': 'laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic sleeve gastrectomy is one of the popular bariatric surgeries known for weight reduction', 'armGroupLabels': ['morbid obesity and overweight in patients with hypothyroidism and depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'zip': '44519', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University Hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of general surgery, faculty of medicine, Zagazig University, Egypt.', 'investigatorFullName': 'Reham Zakaria Mohamed Ahmed', 'investigatorAffiliation': 'Zagazig University'}}}}