Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT01911793
Status:
TERMINATED
Last Update Posted:
2018-03-07
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pfleshner@aol.com', 'phone': '310-289-9224', 'title': 'Phillip Fleshner, MD', 'organization': 'Cedars Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study only accrued 6 patients. Due to poor enrollment and issues with administrative coverage for study it was decided to terminate the study.\n\nNO data analysis has been done and will not be done in the future. This study was closed with the IRB.'}}, 'adverseEventsModule': {'timeFrame': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. Total Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed for this study.', 'description': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.\n\nTotal Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tolerating Low Residue Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': 'by postoperative day 3( 3rd day after surgery)', 'description': '% of patients tolerating a low residue diet on postoperative day 3 will be assessed', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Time to Flatus (Passing Gas Into Stoma Bag)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': 'during 30 day postoperative period', 'description': '\\# of hours after surgery at which point first passage of flatus (gas) into stoma bag', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Time to Passage of Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': 'during 30 day postoperative period', 'description': '\\# of hours after surgery until the patient passes stool into stoma bag', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': '30 day postoperative period', 'description': 'postoperative day after surgery which patient was discharged home', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Time to Discharge Based on GI Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': '30 day postoperative period', 'description': 'postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Major and Minor Medical and Surgical Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': '30 day postoperative period', 'description': 'any major or minor medical and surgical complications after surgery will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Any Insertion of Nasogastric Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': '30 day postoperative period', 'description': 'insertion of nasogastric tube after surgery will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Episodes of Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': 'during postoperative hospital admission (30 day period)', 'description': 'any episodes of vomiting will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}, {'type': 'SECONDARY', 'title': 'Diagnosis of Postoperative Ileus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'OG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'timeFrame': '30 day postoperative period', 'description': 'diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'FG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stoma Tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery\n\nStoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.'}, {'id': 'BG001', 'title': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Not enough staff resource to complete study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2013-07-26', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerating Low Residue Diet', 'timeFrame': 'by postoperative day 3( 3rd day after surgery)', 'description': '% of patients tolerating a low residue diet on postoperative day 3 will be assessed'}], 'secondaryOutcomes': [{'measure': 'Time to Flatus (Passing Gas Into Stoma Bag)', 'timeFrame': 'during 30 day postoperative period', 'description': '\\# of hours after surgery at which point first passage of flatus (gas) into stoma bag'}, {'measure': 'Time to Passage of Stool', 'timeFrame': 'during 30 day postoperative period', 'description': '\\# of hours after surgery until the patient passes stool into stoma bag'}, {'measure': 'Hospital Discharge', 'timeFrame': '30 day postoperative period', 'description': 'postoperative day after surgery which patient was discharged home'}, {'measure': 'Time to Discharge Based on GI Function', 'timeFrame': '30 day postoperative period', 'description': 'postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function'}, {'measure': 'Major and Minor Medical and Surgical Complications', 'timeFrame': '30 day postoperative period', 'description': 'any major or minor medical and surgical complications after surgery will be recorded'}, {'measure': 'Any Insertion of Nasogastric Tube', 'timeFrame': '30 day postoperative period', 'description': 'insertion of nasogastric tube after surgery will be recorded'}, {'measure': 'Episodes of Vomiting', 'timeFrame': 'during postoperative hospital admission (30 day period)', 'description': 'any episodes of vomiting will be recorded'}, {'measure': 'Diagnosis of Postoperative Ileus', 'timeFrame': '30 day postoperative period', 'description': 'diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stoma', 'ileus', 'postoperative', 'stoma tube'], 'conditions': ['Ileus', 'Bowel Obstruction']}, 'referencesModule': {'references': [{'pmid': '19610681', 'type': 'BACKGROUND', 'citation': 'Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.'}, {'pmid': '22576906', 'type': 'BACKGROUND', 'citation': 'Akesson O, Syk I, Lindmark G, Buchwald P. Morbidity related to defunctioning loop ileostomy in low anterior resection. Int J Colorectal Dis. 2012 Dec;27(12):1619-23. doi: 10.1007/s00384-012-1490-y. Epub 2012 May 11.'}, {'pmid': '23183687', 'type': 'BACKGROUND', 'citation': 'Le Q, Liou DZ, Murrell Z, Fleshner P. Does a history of postoperative ileus predispose to recurrent ileus after multistage ileal pouch-anal anastomosis? Tech Coloproctol. 2013 Aug;17(4):383-8. doi: 10.1007/s10151-012-0942-2. Epub 2012 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients. Stomas are frequently created in conjunction with major colorectal surgery. Obstruction at the level of the stoma is a common cause of bowel obstruction or ileus. This is often manifested by decrease or delay in stoma output and is often attributed to edema at the level of the stoma. Thus, a temporary tube (red robinson catheter) is placed into the stoma at bedside, which often relieves the obstruction until the edema at the level of the stoma resolves and stoma function occurs around the temporary tube. At this time, the tube is removed and the stoma continues to function normally.\n\nThe purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed at the time of stoma creation would reduce the incidence of postoperative ileus in patients undergoing major colorectal surgery with creation of a stoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;\n2. Males or females, 18\\> years of age and older inclusive at the time of study screening;\n3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III);\n4. Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy;\n\nExclusion Criteria:\n\n1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;\n2. American Society of Anesthesiologists (ASA) Class IV or V;\n3. Children \\<18 years'}, 'identificationModule': {'nctId': 'NCT01911793', 'briefTitle': 'Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery', 'orgStudyIdInfo': {'id': 'Stoma Tube Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stoma tube', 'description': 'Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery', 'interventionNames': ['Device: Stoma Tube']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Stoma', 'description': 'Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postoperative if the patient is felt to have postoperative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.'}], 'interventions': [{'name': 'Stoma Tube', 'type': 'DEVICE', 'otherNames': ['Red robinson catheter'], 'description': 'Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.', 'armGroupLabels': ['Stoma tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Phillip Fleshner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Colorectal Surgery Residency', 'investigatorFullName': 'Phillip Fleshner MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}