Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06316167
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011178', 'term': 'Postgastrectomy Syndromes'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-10', 'size': 2544381, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-11T14:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants without postoperative GERD', 'timeFrame': '6 months', 'description': 'To evaluate the efficacy of mandatory hiatoplasty performed during gastric sleeve surgery in reducing the incidence of postoperative gastroesophageal reflux disease (GERD) in patients undergoing this procedure in a hospital specializing in bariatric surgery in Tijuana, Baja California.'}], 'secondaryOutcomes': [{'measure': 'Comorbidities in patients undergoing gastric sleeve with hiatoplasty', 'timeFrame': '6 months', 'description': 'These patients usually have significant obesity, often accompanied by comorbidities such as type 2 diabetes, hypertension, sleep apnea, and gastroesophageal reflux disease (GERD).'}, {'measure': 'Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty', 'timeFrame': '6 months', 'description': 'Hiatoplasty is often performed to reduce the risk of postoperative GERD by repairing a herniated hiatus during gastric sleeve surgery. However, the exact incidence of postoperative GERD can vary and depends on factors such as surgical technique, patient anatomy and postoperative management.'}, {'measure': 'Comparison of postoperative complication rates, including GERD', 'timeFrame': '6 months', 'description': 'Postoperative complications may include, but are not limited to, bleeding, infection, sleeve stenosis, and GERD recurrence. Comparison of complication rates between patients with and without mandatory hiatoplasty may provide insight into the effectiveness of this technique in mitigating specific risks.'}, {'measure': 'Postoperative quality of life analysis', 'timeFrame': '6 months', 'description': 'Questionnaire postoperative quality of life with the Bariatric Analysis and Reporting Outcome System (BAROS) Questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Incidence', 'Complications', 'Bariatric surgery', 'Obesity'], 'conditions': ['Postgastrectomy Syndromes', 'Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty\n* Comparison of postoperative complication rates, including GERD\n\nParticipants will answer a follow-up questionnaire, about postoperative quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age of indistinct gender who underwent gastric sleeve with hiatoplasty for obesity or overweight management in a hospital center specialized in bariatric surgery in Tijuana, Baja California.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Gender indistinct.\n* Overweight, obesity grade I, II, III, super obesity or super-super obesity.\n* Underwent gastric sleeve with hiatoplasty for obesity management at a high volume Tijuana hospital dedicated to bariatric surgery.\n\nExclusion Criteria:\n\n* Patient records with incomplete information.'}, 'identificationModule': {'nctId': 'NCT06316167', 'briefTitle': 'Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction', 'orgStudyIdInfo': {'id': 'Hiatoplasty-2024'}}, 'contactsLocationsModule': {'locations': [{'zip': '44329', 'city': 'Guadalajara', 'state': 'Jalisco', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Alejandro González-Ojeda, MD, PhD', 'role': 'CONTACT', 'email': 'avygail5@gmail.com', 'phone': '3331294165'}], 'facility': 'Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'centralContacts': [{'name': 'Alejandro Gonzalez-Ojeda, MD, PhD', 'role': 'CONTACT', 'email': 'avygail5@gmail.com', 'phone': '3331294165'}], 'overallOfficials': [{'name': 'José Aldo Guzmán-Barba, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.'}, {'name': 'Alejandro López-Ortega, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.'}, {'name': 'Helmut Heribert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.'}, {'name': 'Isaac Esparza Estrada, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.'}, {'name': 'Sergio Jiram Vazquez-Sánchez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico'}, {'name': 'Alejandro González-Ojeda, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be kept absolutely confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'GONZALEZ-OJEDA ALEJANDRO', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}