Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
Study NCT ID:
NCT06207357
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-12-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-14', 'size': 158467, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-15T17:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'optical trocar to induce the pneumoperitoneum', 'timeFrame': '5 years', 'description': 'the use of optical trocar to facilitate the creation of the pneumoperitoneum in obese patients underwent bariatric surgery'}, {'measure': 'complication rate using optical trocar to create the pneumopritoneum in laparoscopic surgery', 'timeFrame': '5 years', 'description': 'in literature we observe a low complication rate which include bowel and vessel injuries'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid', 'Bariatric Surgery Candidate', 'Surgery-Complications']}, 'descriptionModule': {'briefSummary': 'Laparoscopic bariatric surgery are becoming the most used procedure to treat the obesity. To facilitate safe initial access to the abdominal cavity, we insert an optical viewing trocar at the left hypocondrium. The aim of this study is to systematically evaluate all published data existing in the literature to analyze the safety of optical trocars in patients undergoing bariatric surgery and to compare these data with our experiences.', 'detailedDescription': 'In this study we analyze data existing in the literature about the use of the optical trocars in patients undergoing bariatric surgery and we compare these data with our experiences.\n\nEstablishing pneumoperitoneum is classically performed using a Veress needle or the open Hasson technique, but obesity presents its own challenges when using these techniques, including thickened abdominal wall, variable anatomical landmarks, difficult and time-consuming dissection, air leak, inadequate pneumoperitoneum, subcutaneous emphysema, and difficulty with fascial closure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI\\>40 kg/m2 BMI\\>35 kg/m2with at least one associated major comorbidity\n\nExclusion Criteria:\n\nsecondary obesity due to endocrine and psychological disorders'}, 'identificationModule': {'nctId': 'NCT06207357', 'briefTitle': 'Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Optical Trocar to Facilitate the Pneumoperitoneum Creation in Bariatric Patients: Our Experience and Systematic Review', 'orgStudyIdInfo': {'id': '9'}}, 'armsInterventionsModule': {'interventions': [{'name': 'optical trocar to create the pneumoperitoneum for bariatric surgery', 'type': 'PROCEDURE', 'description': 'The technique involves the use of 4 12 mm trocars. Pneumoperitoneum is induced by a 0° optical trocar and maintained at 15 mmHg. The first trocar is usually inserted along the left mid-clavicular line approximately 2 fingers from the costal arch, another trocar along the left axillary line, a third trocar 1 cm to the right of the midline, and the fourth trocar along the right mid-clavicular line. A 10 mm, 30 ° laparoscope is used.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71122', 'city': 'Foggia', 'country': 'Italy', 'facility': 'Giovanna Pavone', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Giovanna Pavone', 'investigatorAffiliation': 'University of Foggia'}}}}