Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-06 @ 1:49 PM
Study NCT ID:
NCT03750461
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stoma Closure and Reinforcement Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Matthew.Z.Wilson@hitchcock.org', 'phone': '(603) 650-8113', 'title': 'Matthew Z. Wilson, MD MSc FACS FASCRS', 'organization': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH Geisel School of Medicine, Hanover, NH'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From date of surgery to follow-up at approximately 2 years.', 'description': 'Interventional arm: Adverse events were collected for surgical site occurrences (surgical site infection, mesh infection, delayed wound healing), fascial dehiscence, seroma, hematoma, cellulitis or enterocutaneous fistula, or return to the operating room for mesh removal.\n\nHistorical Controls: Only adverse events relating to wound or organ/space infection and wound disruption were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Historical Controls', 'description': 'Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 9, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': "Ogilvie's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'superficial wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'organ/space infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Wound Occurrences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Incidence of wound occurrences (defined as superficial surgical site infection \\[s-SSI\\], deep surgical site infection \\[d-SSI\\], organ space surgical site infection \\[O-SSI\\], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}, {'id': 'OG001', 'title': 'Historical Controls', 'description': 'Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.'}], 'classes': [{'title': 'superficial wound infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'deep wound infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'organ/space infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'wound disruption', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The incidence of wound occurrences (defined as superficial surgical site infection \\[s-SSI\\], deep surgical site infection \\[d-SSI\\], organ space surgical site infection \\[O-SSI\\], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preliminary Efficacy Based on Number of Participants With Hernia Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}], 'classes': [{'title': '30 Days post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 months post procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days, and then 6 months post procedure', 'description': 'Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up due to declining cancer surveillance.'}, {'type': 'SECONDARY', 'title': 'Bowel Function After Mesh Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life After Mesh Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}, {'id': 'FG001', 'title': 'Historical Controls', 'description': 'Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Primary Endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'comment': 'Considered study completion for the Historical Controls.', 'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Secondary Endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'comment': 'Not applicable for the historical controls.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'comment': 'Not applicable for the historical controls; no follow-up data was collected.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '92'}]}]}], 'recruitmentDetails': 'Adult patients (Interventional group)with left sided CRC who underwent proximal diversion with a LI as part of their surgical therapy were recruited from the clinical practice of the Division of Colon and Rectal Surgery at DHMC between January 2019 and November 2020.\n\nHistorical Controls were patients diagnosed with colorectal cancer and who underwent stoma reversals from January 1, 2011, to December 31, 2018 from the clinical practice of the Division of Colon and Rectal Surgery at DHMC.', 'preAssignmentDetails': '24 Adult patients with left-sided colon and rectal cancer treated with resection and diverting loop ileostomy were eligible to participate. 4 participants declined participation and were not enrolled.\n\nHistorical Controls. Data for only those who met the inclusion criteria was collected. Data collected was only relevant to the Primary endpoint, and additional follow-up date was no collected beyond the data needed for analysis for the primary outcome measure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall\n\nMesh Implantation: Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation'}, {'id': 'BG001', 'title': 'Historical Controls', 'description': 'Patients diagnosed with colon or rectal cancer, identified by relevant International Classification of Disease 9/10 codes, and who underwent a stoma reversal procedure, identified by pertinent current procedural terminology (CPT) codes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '85'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '92'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Mean', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '110', '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': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.19', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '27.3', 'spread': '4.95', 'groupId': 'BG001'}, {'value': '28.245', 'spread': '6.425', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-09', 'size': 426524, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-13T17:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2018-11-13', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-15', 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Wound Occurrences', 'timeFrame': '30 days', 'description': 'Incidence of wound occurrences (defined as superficial surgical site infection \\[s-SSI\\], deep surgical site infection \\[d-SSI\\], organ space surgical site infection \\[O-SSI\\], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.'}, {'measure': 'Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls', 'timeFrame': '30 days', 'description': 'The incidence of wound occurrences (defined as superficial surgical site infection \\[s-SSI\\], deep surgical site infection \\[d-SSI\\], organ space surgical site infection \\[O-SSI\\], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.'}], 'secondaryOutcomes': [{'measure': 'Preliminary Efficacy Based on Number of Participants With Hernia Formation', 'timeFrame': '30 days, and then 6 months post procedure', 'description': 'Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.'}, {'measure': 'Bowel Function After Mesh Implantation', 'timeFrame': '2 years', 'description': 'Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.'}, {'measure': 'Quality of Life After Mesh Implantation', 'timeFrame': '2 years', 'description': 'Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ileostomy', 'hernia', 'rectal cancer', 'colon cancer'], 'conditions': ['Colon Cancer', 'Rectal Cancer', 'Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of large pore monofilament polypropylene mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18years\n2. Patient is undergoing closure of loop ileostomy\n3. Patient has a diagnosis of left sided colon or rectal cancer treated with resection and diverting loop ileostomy\n4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery\n\nExclusion Criteria:\n\n1. Pre-existing systemic infection at the time of ileostomy takedown\n2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder\n3. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone \\>10mg/day)\n4. Previous abdominal hernia repair with mesh placement\n5. Concurrent procedures in addition to closure of diverting loop ileostomy\n6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)'}, 'identificationModule': {'nctId': 'NCT03750461', 'acronym': 'SCAR', 'briefTitle': 'Stoma Closure and Reinforcement Trial', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Stoma Closure and Reinforcement (SCAR) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer Patients', 'orgStudyIdInfo': {'id': 'D18101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall', 'interventionNames': ['Device: Mesh Implantation']}], 'interventions': [{'name': 'Mesh Implantation', 'type': 'DEVICE', 'description': 'Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Matthew Z Wilson, MD, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hitchcock Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Matthew Z. Wilson', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}