Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT04748120
Status:
TERMINATED
Last Update Posted:
2022-03-14
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'petroc@ccf.org', 'phone': '216-444-3501', 'title': 'Dr. Clayton Petro', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '90 days following intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Pulmonary Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'OG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'description': 'Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation\n\nFor operative management this means any episode of non-invasive ventilation, invasive ventilation, or extracorporeal membrane oxygenation after initial extubation after surgery, or patient cannot be extubated as planned after surgery.\n\nFor non-operative management this means any intubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-intervention ICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'OG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'description': 'ICU admission following randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality (All Cause)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'OG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'description': 'Any death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications as Measured by the Clavien-Dindo Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 90 days', 'description': 'The Clavien-Dindo classification is a grading scale from 1 to 5 (with 5 being more severe0 to objectively describe the severity of a complication, including any deviation from the normal postoperative course', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject in the Operative management did not develop any complications that met Clavien-Dindo classification'}, {'type': 'SECONDARY', 'title': 'Median Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'OG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 90 days', 'description': 'Cumulative and individual length of hospitalization(s)', 'unitOfMeasure': 'Hours', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Emergency Room Visits/Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'OG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Failure for Non-operative Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'description': 'Patients randomized to non-operative management who require non-elective surgery to remove the affected organ', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'FG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Operative Management', 'description': 'Treatment with surgery\n\nOperative management: Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.'}, {'id': 'BG001', 'title': 'Non-operative Management', 'description': 'Treatment with antibiotics\n\nNon-operative management: Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '32'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '72', 'upperLimit': '72'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-30', 'size': 698768, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-29T11:31', 'hasProtocol': True}, {'date': '2021-01-06', 'size': 262127, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-02-17T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants will be informed regarding the treatment they receive at the time of randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a prospective, non-blinded, pilot randomized controlled trial comparing operative to non-operative management of acute appendicitis and acute cholecystitis in patients with mild to moderate COVID-19 infection. This will be a two-arm trial with intervention 1: intervention 2 allocation ratio of 1:1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Insufficient eligible patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2021-02-05', 'resultsFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-09', 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Failure for Non-operative Management', 'timeFrame': 'Up to 90 days', 'description': 'Patients randomized to non-operative management who require non-elective surgery to remove the affected organ'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Pulmonary Complications', 'timeFrame': 'Up to 90 days', 'description': 'Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation\n\nFor operative management this means any episode of non-invasive ventilation, invasive ventilation, or extracorporeal membrane oxygenation after initial extubation after surgery, or patient cannot be extubated as planned after surgery.\n\nFor non-operative management this means any intubation'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Post-intervention ICU Admission', 'timeFrame': 'Up to 90 days', 'description': 'ICU admission following randomization'}, {'measure': 'Mortality (All Cause)', 'timeFrame': 'Up to 90 days', 'description': 'Any death'}, {'measure': 'Complications as Measured by the Clavien-Dindo Classification', 'timeFrame': 'Up to 90 days', 'description': 'The Clavien-Dindo classification is a grading scale from 1 to 5 (with 5 being more severe0 to objectively describe the severity of a complication, including any deviation from the normal postoperative course'}, {'measure': 'Median Length of Hospital Stay', 'timeFrame': 'Up to 90 days', 'description': 'Cumulative and individual length of hospitalization(s)'}, {'measure': 'Number of Emergency Room Visits/Readmission', 'timeFrame': 'Up to 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Appendicitis', 'Cholecystitis, Acute', 'Cholecystitis; Gallstone', 'Cholecystitis']}, 'referencesModule': {'references': [{'pmid': '32091533', 'type': 'BACKGROUND', 'citation': 'Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.'}, {'pmid': '32292899', 'type': 'BACKGROUND', 'citation': 'Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.'}, {'pmid': '32221117', 'type': 'BACKGROUND', 'citation': 'Aminian A, Safari S, Razeghian-Jahromi A, Ghorbani M, Delaney CP. COVID-19 Outbreak and Surgical Practice: Unexpected Fatality in Perioperative Period. Ann Surg. 2020 Jul;272(1):e27-e29. doi: 10.1097/SLA.0000000000003925.'}, {'pmid': '30720508', 'type': 'BACKGROUND', 'citation': 'Podda M, Gerardi C, Cillara N, Fearnhead N, Gomes CA, Birindelli A, Mulliri A, Davies RJ, Di Saverio S. Antibiotic Treatment and Appendectomy for Uncomplicated Acute Appendicitis in Adults and Children: A Systematic Review and Meta-analysis. Ann Surg. 2019 Dec;270(6):1028-1040. doi: 10.1097/SLA.0000000000003225.'}, {'pmid': '29090866', 'type': 'BACKGROUND', 'citation': 'Gomi H, Solomkin JS, Schlossberg D, Okamoto K, Takada T, Strasberg SM, Ukai T, Endo I, Iwashita Y, Hibi T, Pitt HA, Matsunaga N, Takamori Y, Umezawa A, Asai K, Suzuki K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, de Santibanes E, Shikata S, Noguchi Y, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Mukai S, Higuchi R, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):3-16. doi: 10.1002/jhbp.518. Epub 2018 Jan 9.'}, {'pmid': '10401823', 'type': 'BACKGROUND', 'citation': 'Davis CA, Landercasper J, Gundersen LH, Lambert PJ. Effective use of percutaneous cholecystostomy in high-risk surgical patients: techniques, tube management, and results. Arch Surg. 1999 Jul;134(7):727-31; discussion 731-2. doi: 10.1001/archsurg.134.7.727.'}, {'pmid': '29032636', 'type': 'BACKGROUND', 'citation': 'Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.', 'detailedDescription': 'As the novel coronavirus disease 2019 (COVID-19) disseminates across the United States, more routine preoperative testing is going to expose infected patients with no or mild pneumonia symptoms. Currently, little is known regarding the true consequences of general anesthesia in COVID-positive (COVID+) patients. Surgeons are going to face challenging decisions regarding whether or not to operate for non-elective cases requiring general anesthesia when non-operative treatment options exist. Patients with acute appendicitis are usually treated with an operation to remove the appendix, but they can also be initially treated with antibiotics and have an operation at a later date. Similarly, patients with acute cholecystitis are usually treated with an operation to remove the gallbladder, but they can be treated with antibiotics and a percutaneous cholecystostomy tube (a tube that going through the skin to drain the gallbladder) and have an operation at a later date. However, patients managed without a definitive operation may require more resource utilization, PPE consumption, interactions with hospital personnel, and could experience treatment failures that exacerbate their viral illness. This is a pilot study comparing the safety of operative versus non-operative management of COVID+ patients with mild to moderate symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* COVID-19 confirmed positive by a microbiologic test.\n* Mild COVID-19 - no or mild pneumonia\n* EITHER\n\n 1. Uncomplicated acute appendicitis without a fecalith OR\n 2. Acute cholecystitis - by TG18/TG13 diagnostic criteria where definite diagnosis requires one item in A + one item in B + C A. Local signs of inflammation etc.\n\n <!-- -->\n\n 1. Murphy's sign\n 2. RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.\n\n <!-- -->\n\n 1. Fever\n 2. elevated CRP\n 3. elevated WBC count C. Imaging findings characteristic of acute cholecystitis\n\nExclusion Criteria:\n\n* Active pregnancy\n* COVID-19 severe disease that would be a contraindication to operative intervention at the discretion of the attending surgeon supported by the following, none of which are individually required or are a strict exclusion criterion as some of these could be attributed or exacerbated by the underlying surgical problem:\n\n 1. Persistent dyspnea\n 2. Persistent respiratory frequency \\>30/min\n 3. Persistent blood oxygen saturation \\<93%\n 4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \\<300\n 5. Lung infiltrates \\>50%\n* COVID-19 critical disease - respiratory failure, shock, or multiorgan dysfunction\n* The surgeon expects increased operative complexity - high risk of conversion to open or prolonged procedure\n* Unable or unwilling to consent or fulfill study procedures - need to complete 90 day follow-up by telephone"}, 'identificationModule': {'nctId': 'NCT04748120', 'briefTitle': 'Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients', 'orgStudyIdInfo': {'id': '20-525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative management', 'description': 'Treatment with surgery', 'interventionNames': ['Procedure: Operative management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-operative management', 'description': 'Treatment with antibiotics', 'interventionNames': ['Procedure: Non-operative management']}], 'interventions': [{'name': 'Operative management', 'type': 'PROCEDURE', 'description': 'Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.', 'armGroupLabels': ['Operative management']}, {'name': 'Non-operative management', 'type': 'PROCEDURE', 'description': 'Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:\n\nNon-penicillin allergic patients\n\n* piperacillin/tazobactam 3.375g IV every 6 hours for 3 days\n* amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days\n\nPenicillin allergic patients\n\n* ertapenem 1g IV every 24 hours for 3 days\n* ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days\n\nPatients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.', 'armGroupLabels': ['Non-operative management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Clayton C Petro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Clayton Petro', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}