Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-30 @ 7:28 PM
Study NCT ID:
NCT06758934
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-28', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-28', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Textbook Outcome', 'timeFrame': '30 days', 'description': 'The criteria required for a patient who underwent total gastrectomy to have reached a textbook outcome are as follows:\n\n* no intraoperative complication,\n* achievement of tumor-negative margin,\n* including ≥15 harvested lymph nodes in resected specimen,\n* no severe postoperative complication(Clavien-Dindo Score≥3, (CD)),\n* no reintervention,\n* no readmission to intensive care unit after once coming to the surgical ward,\n* no prolonged hospital stay (≤21 days),\n* no postoperative mortality (30 days) and\n* no readmission after discharge from the hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Gastrectomy', 'Textbook Outcome', 'Open Gastrectomy', 'Minimally Invasive Surgery'], 'conditions': ['Gastrectomy', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome', 'detailedDescription': 'Gastric cancer patients underwent total gastrectomy with curative intent between July 2018 and January 2024 in a single center were included in this retrospective observational study. Enrolled patients divided to two groups as open total gastrectomy (open group) and laparoscopic total gastrectomy (lap group).\n\nData of patients obtained via the hospital software system. Demographic data, body mass index(BMI), Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, tumor characteristics and textbook outcome results were investigated. Postoperative complications were pancreatic fistula, pleural effusion, pneumonia, anastomotic leak, intraabdominal abscess, surgical site infection, postoperative ileus.\n\nAll patients were already curative surgery patients and underwent total gastrectomy and D2 lymphadenectomy. Apart from this, the list of criteria for a patient who had a textbook outcome was as follows: no intraoperative complication, achievement of tumor-negative margins, including ≥15 harvested lymph nodes in resected specimen, no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), no reintervention, no readmission to intensive care unit after once coming to the surgical ward, no prolonged hospital stay (≤21 days), no postoperative mortality (30 days) and no readmission after discharge from the hospital'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gastric cancer patients ≥ 18 years old and underwent total gastrectomy with curative intent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastric cancer patients underwent total gastrectomy with curative intent\n\nExclusion Criteria:\n\n* Emergency surgery,\n* Recurrent disease\n* Metastatic disease,\n* Conversion to open surgery,\n* Robotic gastrectomy.'}, 'identificationModule': {'nctId': 'NCT06758934', 'briefTitle': 'Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer', 'orgStudyIdInfo': {'id': '20240213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open Group', 'description': 'Gastric cancer patients underwent open total gastrectomy with curative intent between July 2018 and January 2024'}, {'label': 'Lap Group', 'description': 'Gastric cancer patients underwent laparoscopic total gastrectomy with curative intent between July 2018 and January 2024'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Alpen Yahya Gümüşoğlu, Ass. Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets generated and analysed during the current study are not available due to institutional policies but are available from the corresponding author on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. Dr.', 'investigatorFullName': 'Turgut Donmez', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}