Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06372912
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Postoperative Complications in Patients Undergoing Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Postoperative Complications', 'timeFrame': '30 days', 'description': 'Within 30 days following surgery, the incidence of anastomotic leaks and surgical site bleeding is the main safety consequence. This outcome measure is essential for proving the safety and enhanced recovery profile, since the technique emphasizes rigorous hemostasis and anastomotic integrity-achieved through reinforced suturing and patency verification using methylene blue tests.'}], 'secondaryOutcomes': [{'measure': 'Long-term Weight Loss Efficacy', 'timeFrame': '12 months', 'description': ": The percentage of excess weight loss (%EWL) at 12 months after surgery is the main indicator of efficacy. One of the main objectives of bariatric surgery is to achieve significant and long-lasting weight loss. The percentage EWL is calculated using the patient's weight reduction from pre-surgery to a year after surgery, normalized to their excess weight using optimum body weight guidelines."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Candidate', 'Complication,Postoperative']}, 'descriptionModule': {'briefSummary': "This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery.", 'detailedDescription': 'This study, conducted in specialised high-volume bariatric surgery centres in Tijuana, Baja California, Mexico, aimed to analyze the outcomes of various bariatric surgery procedures. It include patients who underwent surgeries like sleeve gastrectomy, gastric bypass, and others. The surgeries were performed by five specialized surgeons with assistance from ten bariatric surgery subspecialists. The researchers reviewed electronic medical records and excluded patients with incomplete information. Postoperative complications requiring additional medical or surgical interventions were noted. Statistical analysis was conducted using SPSS software, focusing on descriptive measures like frequencies, percentages, means, and standard deviations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included patients aged 18 and above with varying degrees of overweight or obesity who underwent bariatric surgery at specialized centers in Tijuana, Mexico. The surgeries examined were sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement. These procedures were performed by five bariatric surgery specialists with assistance from ten certified subspecialists. Patients with incomplete medical records were excluded. Immediate postoperative complications were defined as events requiring additional medical or surgical interventions beyond routine care.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and above\n* Varying degrees of overweight or obesity who underwent surgery at the participating hospitals\n\nExclusion Criteria:\n\n* incomplete or insufficient information in their medical records'}, 'identificationModule': {'nctId': 'NCT06372912', 'briefTitle': 'Early Postoperative Complications in Patients Undergoing Bariatric Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Incidence of Early Postoperative Complications in Patients Undergoing Bariatric Surgery in 2022 Tijuana, Baja California', 'orgStudyIdInfo': {'id': 'Complications-Bariatric-TJ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing bariatric surgery', 'interventionNames': ['Procedure: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.']}], 'interventions': [{'name': 'Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.', 'type': 'PROCEDURE', 'description': 'Sleeve gastrectomy: reduces stomach size. Roux-en-Y gastric bypass: limits calorie absorption. Mini gastric bypass: achieves weight loss with fewer incisions. SADIS: combines sleeve gastrectomy with small bowel bypass. Intragastric balloon: reduces stomach volume. Gastric banding: restricts food intake.', 'armGroupLabels': ['Patients undergoing bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22046', 'city': 'Tijuana', 'state': 'Estado de Baja California', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'José a Guzmán Barba, MD, PhD', 'role': 'CONTACT', 'email': '• aldogbarba@hotmail.com', 'phone': '3471043237'}], 'facility': 'Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}], 'centralContacts': [{'name': 'José A Guzmán Barba, MD, PhD', 'role': 'CONTACT', 'email': 'aldogbarba@hotmail.com', 'phone': '3471043237'}], 'overallOfficials': [{'name': 'Jesús E Ortiz Gómez, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.'}, {'name': 'Almino Cardoso Ramos, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.'}, {'name': 'Jaime Ponce de León Palomares, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.'}, {'name': 'José S Verboonen Sotelo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico'}, {'name': 'Jeffry Romero Manzano, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.'}, {'name': 'Isaac Esparza Estrada, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico'}, {'name': 'Alejandro González Ojeda, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor at the Faculty of Medicine of the Universidad de Colima. Colima, Mexico'}, {'name': 'Christian Rodríguez López, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Body Art Surgical, Edificio Corporativo Central, Diego Rivera 2311, Zona Urbana Rio Tijuana, 22010 Tijuana, Baja California, Mexico.'}, {'name': 'Clotilde Fuentes-Orozco, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Senior Researcher B, Biomedical Research. Unidad de Investigación Biomédica 02, Unidad Médica de Alta Especialidad, Hospital de Especialidades del Centro Médico Nacional de Occidente del Instituto Mexicano del Seguro Social. Guadalajara, Jalisco. México'}, {'name': 'Sergio J Vázquez-Sánchez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unidad de Investigación Biomédica 02, Unidad Médica de Alta Especialidad, Hospital de Especialidades del Centro Médico Nacional de Occidente del Instituto Mexicano del Seguro Social'}, {'name': 'Hector J Pérez Corzo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Renew Bariatrics, Bariatric Surgery Department, Tijuana, Baja California, Mexico'}, {'name': 'José O Orozco Álvarez Malo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico.'}, {'name': 'Jhonattan A Barriga Fong, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}