Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-03-03 @ 4:47 AM
Study NCT ID:
NCT04392661
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2020-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the number of females that got pregnant from79 females seeking pregnancy', 'timeFrame': 'Five years follow-up', 'description': 'effect of LSG and LRYGB on female fertility and getting pregnant'}, {'measure': 'percentage excess weight loss after bariatric surgery', 'timeFrame': 'Five years follow-up', 'description': 'effect of LSG and LRYGB on percentage excess weight loss after bariatric surgery on females'}], 'secondaryOutcomes': [{'measure': 'comorbidity improvement or resolution after bariatric surgery', 'timeFrame': 'Five years follow-up', 'description': 'effect of LSG and LRYGB on comorbidities on females'}, {'measure': 'postoperative complications or mortality after bariatric surgery', 'timeFrame': 'Five years follow-up', 'description': 'postoperative complications or mortality after LSG and LRYGB in obese females'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Female Fertility and Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Maternal morbid obesity is an important risk factor in modern obstetrics, it has been associated with higher infertility rates and obstetrics complications. Bariatric surgery proven to achieve long term weight loss with improvement in all obesity related morbidities. This study was to compare the 5 years outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of fertility outcomes, breast feeding, weight loss, safety, and resolution of obesity related co-morbidity.', 'detailedDescription': 'This study included 197 adult morbidly obese females, 111 underwent LSG (group I) and 86 LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In the LSG group, 14 patients (12.6%) suffered from infertility, and 24 patients (21.6%) were at pre-marriage stage. This is versus 15 patients (17.4%), and 26 patients (30.2%) in the LRYGB group respectively.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary goal of conceiving and complaining from infertility either primary or secondary as well as those who were seeking weight loss in preparation for marriage\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04392661', 'briefTitle': 'Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up, Single Center Study', 'orgStudyIdInfo': {'id': 'Fertility & bariatric surgery'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopic Sleeve Gastrectomy (group I)', 'description': '111 morbid obese females underwent LSG (group I). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.', 'interventionNames': ['Procedure: Laparoscopic Sleeve Gastrectomy']}, {'label': 'Laparoscopic Roux-en-Y Gastric Bypass (group II)', 'description': '86 morbid obese females underwent LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.', 'interventionNames': ['Procedure: Laparoscopic Sleeve Gastrectomy']}], 'interventions': [{'name': 'Laparoscopic Sleeve Gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopic Roux-en-Y Gastric Bypass'], 'description': 'bariatric surgeries and data collection', 'armGroupLabels': ['Laparoscopic Roux-en-Y Gastric Bypass (group II)', 'Laparoscopic Sleeve Gastrectomy (group I)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of general and pediatric surgery', 'investigatorFullName': 'Mohamed Ali Shehata', 'investigatorAffiliation': 'Tanta University'}}}}