Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:44 PM
Study NCT ID:
NCT04849403
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2021-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TROCAR SITE HERNIA AFTER LSG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], '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'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '61 patients who underwent Laparoscopic Sleeve Gastrectomy are included. USG was performed (Figure I,II) by a clinician who had previously received superficial USG evaluation training for trocar site hernia and abdominal incision sites were investigated for the presence of hernias.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2021-04-10', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of incisional hernia', 'timeFrame': '2-4 years', 'description': 'Superficial abdominal Ultrasound for the incisional hernia to trocar sites.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Sleeve Gastrectomy', 'Morbid obesity', 'Trocar site hernia', 'Carter Thomasson Suture Passer'], 'conditions': ['Obesity, Morbid', 'Hernia Incisional']}, 'descriptionModule': {'briefSummary': 'Today, laparoscopic sleeve gastrectomy (LSG) has become the most frequently performed bariatric surgical method. One of the complications seen after LSG is trocar site hernia (TSH). There is no clear information about the rate of TSH detected radiologically after LSG. Thick abdominal wall and failure to adequately expose the facial defect related to this, mobility limitations due to excessive subcutaneous fatty tissue are the reasons accused for increased incidence of TSH.\n\nDemographic characteristics and postoperative weight loss of patients who underwent LSG procedure in our clinic between January 2015 and June 2017 and whose facial defects in the trocar region were repaired with the Carter-Thomason Suture Passer (CTSP) were evaluated. TSH evaluation was made both by physical examination and superficial USG by a general surgeon who had radiological training on concurrent superficial abdominal ultrasonography (USG). Detected TSHs were divided into two groups as symptomatic and asymptomatic.', 'detailedDescription': 'This study included 61 patients who applied to the obesity follow-up outpatient clinic for any complaints or routine control over a 3-month period or who were called by telephone for control and who underwent laparoscopic sleeve gastrectomy for morbid obesity between January 2015- June 2017. Patients with symptoms associated with trocar site hernia were also included in the study, while patients with multiple bariatric surgical procedures or abdominal operations were excluded. Physical examinations to detect hernias were performed both in standing and supine positions for all patients and also during increased abdominal pressure by the Valsalva maneuver. All abdominal incision sites were examined. On physical examination, a hernia was defined as a bulging during the Valsalva maneuver and palpation of the fascial defect. USG was performed (Figure I,II) by a clinician who had previously received superficial USG evaluation training for trocar site hernia with a GE pro 500, 3 MHz and abdominal incision sites were investigated for the presence of hernias.\n\nThe trocar entry localizations of the patients were all the same and are as follows: one 15-mm camera trocar (supraumbilical) , one 10-mm working trocar (left upper quadrant), two 5-mm working trocars (right and left upper quadrant) and one 5-mm liver retractor. Trocar entry localizations are shown in Figure III. During fascia closure procedure, No. 0 absorbable suture (PolyglactinYü-ce Vicryl Ⓡ, Tekirdag, Turkey ) was used with the CTSP (Figure IV). The collected data were recorded in a pre-established database with age, gender, Diabetes Mellitus (DM), postoperative follow-up period, BMI at the time of operation and BMI during superficial USG.\n\nThis study was approved by the Ethics Committee of University of Health Sciences Istanbul Fatih Sultan Mehmet Training and Research Hospital (12.09.2019 / 80).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients above 18 years old.\n* The patient who went Laparoscopic Sleeve Gastrectomy (LSG) procedure for morbid obesity.\n\nExclusion Criteria:\n\n* The patients who needed to have additional surgery after the LSG in their follow up.\n* The patients who could not reached and did not attend to the Ultrasound examination.\n* The patient who did not approve the participate to the study.'}, 'identificationModule': {'nctId': 'NCT04849403', 'briefTitle': 'TROCAR SITE HERNIA AFTER LSG', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'EVALUATION OF THE FREQUENCY OF TROCAR SITE HERNIA AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY', 'orgStudyIdInfo': {'id': 'DR.ANIL ERGIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'The group USG was applied', 'description': 'USG was applied to the patients who underwent Laparoscopic sleeve gastrectomy for research trocar site hernia after 2-4 years from the surgery. Carter Thomasson suture passer was used to close fascial defect in all patients.', 'interventionNames': ['Procedure: CTSP']}], 'interventions': [{'name': 'CTSP', 'type': 'PROCEDURE', 'description': 'In all patients Carter Thomasson Suture Passer (CTSP) were used for closing fascial defect peroperatively', 'armGroupLabels': ['The group USG was applied']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34734', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Anıl Ergin', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Anil Ergin', 'investigatorFullName': 'ANIL ERGIN', 'investigatorAffiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}}}}