Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 9:52 AM
Study NCT ID:
NCT04288661
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2020-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Perianastomotic Drain After Gastrectomy (DRAG)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'malvina_el@hotmail.com', 'phone': '+30 6945176503', 'title': 'Dr Maria Malvina Eleftheriou', 'organization': '1st Propaedeutic Surgery Department,Hippocration Hospital,University of Athens, Greece'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': '1 adverse event:intraoperative pancreatic injury', 'eventGroups': [{'id': 'EG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 2, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'anastomotic leak', 'notes': 'anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'postoperative bleeding', 'notes': 'Postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'pancreatic inlury', 'notes': 'pancreatic injury/leak due to compression during lymph node dissection, detected 2 days later', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': "Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups:\n\nHigh pain: VAS score greater than 5\n\nNot high pain: VAS score 5 or less\n\nThis binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Delay of Feeding Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Delay of Postoperative Mobilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'immediate effect of drain placement', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Day of Postoperative Bowel Mobilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital stay approx 5 days', 'description': 'immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'short term effect of drain placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgically Related Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'short term effect of drain placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reoperations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'OG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'short term effect of drain placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'FG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'id': 'BG001', 'title': 'No Drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.\n\nNo drain placement: The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '87'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '77.5'}, {'value': '73', 'groupId': 'BG002', 'lowerLimit': '48', 'upperLimit': '87'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-01', 'size': 372247, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-01T10:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2020-02-23', 'resultsFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-09', 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': "Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups:\n\nHigh pain: VAS score greater than 5\n\nNot high pain: VAS score 5 or less\n\nThis binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain."}, {'measure': 'Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results'}, {'measure': 'Number of Participants With Delay of Feeding Initiation', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol'}, {'measure': 'Number of Participants With Delay of Postoperative Mobilization', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Hospital stay, an average of 5 days', 'description': 'immediate effect of drain placement'}, {'measure': 'Day of Postoperative Bowel Mobilization', 'timeFrame': 'Hospital stay approx 5 days', 'description': 'immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'short term effect of drain placement'}, {'measure': 'Surgically Related Readmissions', 'timeFrame': '30 days', 'description': 'short term effect of drain placement'}, {'measure': 'Reoperations', 'timeFrame': '30 days', 'description': 'short term effect of drain placement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prophylactic drain', 'total gastrectomy', 'gastric cancer', 'esophagogastric anastomosis leak', 'drain criteria'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract reconstruction .It has long been established that minimizing surgical intervention correlates with faster patient recovery. The Enhanced Recovery After Surgery (ERAS) guidelines provide globally recognized perioperative recommendations for a variety of surgical procedures, grounded in research, audits, and evidence-based practice. In 2014, Mortensen et al. introduced ERAS guidelines specifically tailored for gastrectomy in gastric cancer. These guidelines include both procedure-specific and general recommendations applicable to the perioperative management of abdominal surgeries.Since the publication of ERAS guidelines, evidence suggests limited and inconsistent global adherence to the protocol for gastrectomy, particularly regarding surgical drain use.Drains remain in use for gastrectomy, particularly in the East, where ongoing studies explore the prognostic value of drain contents post-gastrectomy without reaching consensus. Western adherence to ERAS recommendations on drains is similarly low.This prospective, non-randomized controlled clinical trial aims to assess the impact of one perianastomotic drain when it is placed under specific, predefined criteria. The trial evaluates the immediate and short-term postoperative outcomes in patients who underwent D2 total gastrectomy for gastric cancer which were performed in a high-volume centre and under the care of a highly experienced team', 'detailedDescription': "The DRAG (DRains After Gastrectomy) Trial is a prospective, non-randomized, controlled clinical trial involving patients diagnosed with gastric neoplasm. All surgeries were performed by a single, highly experienced surgeon in the 1st Propaedeutic Surgery Department at Hippocration General Hospital in Athens, Greece. The patients underwent open total gastrectomy with D2 lymph node dissection, followed by Roux-en-Y gastrointestinal tract reconstruction, in accordance with a predefined, ERAS-compliant perioperative departmental protocol. Our institution's protocol does not routinely incorporate exploratory laparoscopy or peritoneal cytology.\n\nThe participants were divided into two groups. The first group followed the department's standard practice, with a drain placed near the esophagojejunal anastomosis (drain group). In contrast, the second did not have a drain placed (non-drain group). The decision to place a drain was based on the following criteria:\n\n1. Pulmonary diseases under oxygen therapy\n2. Chronic oral steroid use (≥5mg/day prednisone equivalent for \\>1month)\n3. Intraoperative hemodynamic instability requiring vasopressors\n4. Intraoperative blood loss exceeding 250 mL\n5. Vessel injury (celiac axis or its branches)\n6. Injury to adjacent structures (pancreas, spleen, duodenum)\n7. Tension of the anastomosis\n8. Uncertainty regarding duodenal stump integrity due to either staple misfire or tissue quality issues Per our departmental protocol, patients were gradually mobilized starting directly after surgery, when feasible. On the second postoperative day, an oral gastrografin study was conducted for each patient to detect any early anastomotic leaks. Following a normal radiological study, patients were initiated on a liquid diet, which was then advanced to pureed food on the third postoperative day, and a soft diet on the fourth day. For patients in the drain group, the drain was removed on the fifth postoperative day, provided that the drainage volume was less than 50 mL over the preceding 48 hours, in line with departmental protocol The primary outcomes measured in this study were: a) pain levels, assessed using the Visual Analog Scale (VAS) during the first 5 postoperative days, b) postoperative nausea and vomiting (PONV) within the first 5 days, c) initiation of feeding, d) postoperative bowel mobilization, e) patient mobilization, f) length of hospital stay (LOS) Secondary outcomes included: a) mortality, b) surgically related readmissions and c) reoperations This study was conducted in accordance with the principles outlined in the Helsinki Declaration of Human Rights and with the Guidelines of Good Clinical Practice . The final study protocol and the informed consent form for participant inclusion received approval from the Institutional Review Board (IRB). The IRB also conducted regular assessments, as required, to ensure the ongoing compliance with lawful medical practice throughout the trial.\n\nThe statistical analysis was performed using the R software (R foundation for Statistical Computing) version 4.3.0 for Windows. Descriptive characteristics for the quantitative data were expressed as median and Quartile 1 (Q1) to Quartile 3 (Q3) range and for completeness reasons the mean ± standard deviation (SD), for the qualitative data was reported the frequency of occurrence and the relevant percentage. Comparisons were preformed between patients with drainage and those without drainage; for the qualitative parameters statistical tests were performed via the chi-square test (and if required a Fisher exact test) and for the arithmetic data (as normality was not possible to be ensured using the Shapiro Wilk test), were applied not parametric tests, specifically the Mann Whitney U test. The significance level (p-value) was set to 0.05, thus statistically significant difference between compared groups was for p\\<0.05 and all tests were two sided."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Histologically proven EGJ (Siewert II or III) or non-EGJ gastric adenocarcinoma (intestinal, diffuse, or mixed Lauren type)\n* Surgical candidates for total gastrectomy plus D2 lymph node dissection\n* ECOG performance status 0 or 1\n* Signed informed consent from\n* Preoperative evaluation of cTanyNanyM0 according to the American Joint Committee on Cancer Staging Manual, 7th edition\n\nExclusion Criteria:\n\n* M1 disease\n* Other unplanned organ excision\n* Massive ascites or cachexia\n* Current participation in any other clinical trial\n* Severe cardiovascular, respiratory tract, kidney, liver, or psychiatric disease.\n* Poor compliance to the clinical protocol\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04288661', 'acronym': 'DRAG', 'briefTitle': 'Perianastomotic Drain After Gastrectomy (DRAG)', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer', 'orgStudyIdInfo': {'id': '1678 / 31-01-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Drain', 'description': 'The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice'}, {'type': 'EXPERIMENTAL', 'label': 'No drain', 'description': 'The patients of this arm do not undergo perianastomotic drain placement.', 'interventionNames': ['Procedure: No drain placement']}], 'interventions': [{'name': 'No drain placement', 'type': 'PROCEDURE', 'description': 'The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above', 'armGroupLabels': ['No drain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Hippocration General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Dimitrios Theodorou, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Athens'}, {'name': 'Maria-Malvina Eleftheriou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hippocration General Hospital of Athens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'THEODOROU DIMITRIOS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'THEODOROU DIMITRIOS', 'investigatorAffiliation': 'University of Athens'}}}}