Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT03015935
Status:
UNKNOWN
Last Update Posted:
2017-01-16
First Post:
2017-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Entry time', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity, Morbid'], 'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'Laparoscopic surgery has become very popular and standard in many indications after advancements of technique. Various methods have been used in first entry to the abdomen. Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced.\n\nThere is no consensus yet on an optimal method has yet emerged.\n\nThe investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen.\n\nTo evaluate the efficacy of entry technique, the investigators used cohort of patients who will be planned to laparoscopic obesity surgery.\n\nTwo methods are commonly used in surgical literature and in our center.\n\nThe investigators have been used visible optical-entry technique in some patients for first entry and Veress technique in some other patients.\n\nFor this purpose, the investigators designed an observational study.', 'detailedDescription': 'Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced.\n\nThese methods include the standard technique of insufflation after insertion of the Veress needle, the open (Hasson technique), the direct trocar insertion and optical trocar insertion. Furthermore, it is more difficult to perform in the obese patient, especially if the first trocar is not umbilical, like obesity surgery. This is because obese patients have a very thick abdominal wall (particularly in women) as well as a thick peritoneum.\n\nVery different complications, some even potentially fatal, i.e., injury to viscera or to major intra-abdominal and abdominal wall vessels, have been reported in surgical literature. Complications of first entry develop in up to 1-2% of patients and more than half of all are fatal complications. Major vascular and abdominal organ injury rates of 0.03-0.1% and 0.08-0.14%, respectively, have been reported. Surprisingly, there has been little change in entry techniques since the dawn of laparoscopic surgery. Some risk factors are defined for prediction of complications, such as obesity. Laparoscopic obesity surgery has become very attractive and gaining popularity, recently, and however it possess many complications and challenges such as (it starts with) entry to the abdomen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are eligible for laparoscopic obesity surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with body mass index of \\>40\n\nExclusion Criteria:\n\n* Patients who have skin disease at operation area'}, 'identificationModule': {'nctId': 'NCT03015935', 'briefTitle': 'Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery. A Prospective Controlled-cohort Study', 'orgStudyIdInfo': {'id': 'First_Trocar_Entery'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Optical', 'description': 'visual-assisted entry', 'interventionNames': ['Procedure: visual-assisted entry']}, {'label': 'Veress', 'description': 'Veress entry', 'interventionNames': ['Procedure: Veress entry']}], 'interventions': [{'name': 'visual-assisted entry', 'type': 'PROCEDURE', 'description': 'First trocar entry will be performed with visual-assisted trocar', 'armGroupLabels': ['Optical']}, {'name': 'Veress entry', 'type': 'PROCEDURE', 'description': 'First trocar entry will be performed with Veress', 'armGroupLabels': ['Veress']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Ümraniye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatih Basak', 'role': 'CONTACT', 'phone': '5055034571'}], 'facility': 'Umraniye Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Fatih Basak, MD', 'role': 'CONTACT', 'email': 'fatihbasak@gmail.com', 'phone': '5055034571'}], 'overallOfficials': [{'name': 'Fatih Basak', 'role': 'STUDY_CHAIR', 'affiliation': 'Umraniye Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Fatih Basak', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}