Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT04450758
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2020-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-17', 'size': 842699, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-17T12:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-17', 'studyFirstSubmitDate': '2020-06-14', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with 30-day severe morbidity', 'timeFrame': '30 days', 'description': 'Clavien-Dindo \\>3 within 30 days postop'}, {'measure': 'Overall survival after 3 years', 'timeFrame': '3 years', 'description': 'survival unspecified'}, {'measure': 'Number of patients with 30 day mortality', 'timeFrame': '30 days', 'description': 'death within 30 days'}, {'measure': 'Overall survival after 5 years', 'timeFrame': '5 years', 'description': 'survival unspecified'}, {'measure': 'Number of patients with 90 day mortality', 'timeFrame': '90 days', 'description': 'death within 90 days'}], 'secondaryOutcomes': [{'measure': 'Number of patients with locally radical resections', 'timeFrame': '90 days', 'description': 'resections regarded as R0'}, {'measure': 'Number of examined mesenteric lymph nodes', 'timeFrame': '90 days', 'description': 'lymph nodes examined by pathologist'}, {'measure': 'Proportion of patients receiving neoadjuvant or adjuvant treatment', 'timeFrame': '1 year', 'description': 'patients receiveing chemotherapy'}, {'measure': 'Proportion of patients with stomas after 3 years', 'timeFrame': '3 years', 'description': 'patients with bowel continuity without stome'}, {'measure': 'Recurrence rate after 3 after years', 'timeFrame': '3 years', 'description': 'relapse within 3 years'}, {'measure': 'Disease-free survival after 3 years', 'timeFrame': '3 years', 'description': 'survival without disease relapse after 3 years'}, {'measure': 'Proportion of patients not being subjected to resection of initially decompressed', 'timeFrame': '90 days', 'description': 'patients not proceeding to resection'}, {'measure': 'bridging interval', 'timeFrame': '90 days', 'description': 'interval between stenting or stoma and resection'}, {'measure': 'Number of stent complications (perforations, migration, bleeding, success rate etc)', 'timeFrame': '90 days', 'description': 'complications in stent group'}, {'measure': 'Number of stoma complications', 'timeFrame': '90 days', 'description': 'complications in stoma group'}, {'measure': 'Morbidity and survival and impact of tumour location', 'timeFrame': '5 years', 'description': '30 day morbidity and mortality depending on tumour location i.e. right or left colon'}, {'measure': 'Number of laparoscopic resections', 'timeFrame': '90 days', 'description': 'numbers of laparoscopic vs open resections'}, {'measure': 'Number of primary anastomosis', 'timeFrame': '90 days', 'description': 'number of primary anastomosis in the Bridge to Surgery vs up front resection group'}, {'measure': 'Number of stomas after resection and type of stoma', 'timeFrame': '90 days', 'description': 'number of stomas in Bridge to Surgery vs up front resection group'}, {'measure': 'total hospital stay in days', 'timeFrame': '90 days', 'description': 'days in hospital in Bridge to Surgery vs up front resection'}, {'measure': 'colorectal surgeon performing resectional surgery', 'timeFrame': '90 days', 'description': 'qualified colorectal surgeon, general surgeon or resident performing resectional surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 \\& 5 years overall survival', 'detailedDescription': 'The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective observational cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Symptomatic large bowel obstruction requiring acute intervention\n* CT-verified colon obstruction due to colon cancer independent of presence of metastases\n* Informed consent\n\nExclusion Criteria:\n\n* Colonic perforation or bleeding\n* Colonic obstruction of other origin than colon cancer\n* Palliative situation'}, 'identificationModule': {'nctId': 'NCT04450758', 'acronym': 'ACBC', 'briefTitle': 'Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Skane University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'resection', 'description': 'Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection.'}, {'label': 'bridge to sugery', 'description': 'Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with bridge to surgery i.e. either stent or stoma and resection later on.', 'interventionNames': ['Procedure: Bridge to Surgery (stent or stoma)']}], 'interventions': [{'name': 'Bridge to Surgery (stent or stoma)', 'type': 'PROCEDURE', 'description': 'The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.', 'armGroupLabels': ['bridge to sugery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jennifer Park, PhD MD', 'role': 'CONTACT', 'phone': '031-3421000'}, {'name': 'Forskningssk, RN', 'role': 'CONTACT', 'phone': '031-3421000'}], 'facility': 'Göteborg University', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Pamela Buchwald, PhD MD', 'role': 'CONTACT', 'email': 'pamela.buchwald@med.lu.se', 'phone': '004640331000'}, {'name': 'Caroline Nilsson, RN', 'role': 'CONTACT', 'email': 'caroline.n.nilsson@skane.sese', 'phone': '0046331000'}], 'overallOfficials': [{'name': 'Pamela Buchwald, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skåne University Hospital, Lund University'}, {'name': 'Tobias Axmarker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Skåne University Hospital, Lund University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant colorectal surgeon, associate professor', 'investigatorFullName': 'Pamela Buchwald', 'investigatorAffiliation': 'Skane University Hospital'}}}}