Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-26 @ 12:59 PM
Study NCT ID:
NCT01682395
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2012-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045822', 'term': 'Intestinal Volvulus'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014102', 'term': 'Torsion Abnormality'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D003125', 'term': 'Colostomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004766', 'term': 'Enterostomy'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D010030', 'term': 'Ostomy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2012-09-06', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anastomotic Leak', 'timeFrame': '30-Day', 'description': 'Communication of the intraluminal and extraluminal space ad defined by clinical presence of a fecal fistula or operative determination of breakdown of the anastomosis within 30 days of surgery. Of note the NG-SV mesosigmoidopexy arm will not be included in this outcome as there is no anastomosis.'}, {'measure': 'Stomal Complications', 'timeFrame': '3 Year', 'description': 'Stomal complications (necrosis, pain, skin irritation, retraction, prolapse, stenosis, parastomal herniation, ventral hernia at prior stoma incision) within 3 years of surgery. Of note the G-SV Resection and colostomy arm will be the only arm included in this outcome as none of the other arms include a colostomy.'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30-Day', 'description': 'Mortality within 30 days of surgery, as determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin)per study protocol.'}], 'secondaryOutcomes': [{'measure': 'Recurrence of Sigmoid Volvulus', 'timeFrame': '3 Year', 'description': 'Recurrence of sigmoid volvulus confirmed radiologically or operatively within 3 years of surgery. This will be determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin, and if recurrence diagnosed outside of study site contact with the treating physician) per study protocol.'}, {'measure': 'Surgical Site Infection', 'timeFrame': '30-Day', 'description': 'Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intestinal volvulus', 'Colon, sigmoid', 'Anastomosis, surgical', 'Anastomotic leak', 'Malawi', 'Developing Country'], 'conditions': ['Intestinal Volvulus', 'Colon, Sigmoid']}, 'referencesModule': {'references': [{'pmid': '20236153', 'type': 'BACKGROUND', 'citation': 'Raveenthiran V, Madiba TE, Atamanalp SS, De U. Volvulus of the sigmoid colon. Colorectal Dis. 2010 Jul;12(7 Online):e1-17. doi: 10.1111/j.1463-1318.2010.02262.x. Epub 2010 Mar 10.'}, {'pmid': '21322064', 'type': 'BACKGROUND', 'citation': 'Akinkuotu A, Samuel JC, Msiska N, Mvula C, Charles AG. The role of the anatomy of the sigmoid colon in developing sigmoid volvulus: a case-control study. Clin Anat. 2011 Jul;24(5):634-7. doi: 10.1002/ca.21131. Epub 2011 Feb 14.'}, {'pmid': '22184737', 'type': 'BACKGROUND', 'citation': 'Samuel JC, Msiska N, Muyco AP, Cairns BA, Charles AG. An observational study addressing the anatomic basis of mesosigmoidopexy as a rational treatment of non-gangrenous sigmoid volvulus. Trop Doct. 2012 Jan;42(1):44-5. doi: 10.1258/td.2011.110317. Epub 2011 Dec 19.'}], 'seeAlsoLinks': [{'url': 'http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42012002137', 'label': 'Related meta-analysis and systematic review registration'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.', 'detailedDescription': "Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe Malawi with sigmoid volvulus will be eligible for inclusion.\n\nProcedures (methods): This is a prospective randomized trial. Subjects will be randomized during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous sigmoid volvulus)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty\n\nExclusion Criteria:\n\n* pregnancy,\n* age under 18 years,\n* prisoners'}, 'identificationModule': {'nctId': 'NCT01682395', 'briefTitle': 'Best Management of Sigmoid Volvulus: A Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Best Management of Sigmoid Volvulus: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '12-1091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'G-SV Resection and colostomy', 'description': 'Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis', 'interventionNames': ['Procedure: Resection and colostomy']}, {'type': 'EXPERIMENTAL', 'label': 'G-SV Resection and anastomosis', 'description': 'Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis', 'interventionNames': ['Procedure: Resection and anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NG-SV resection and anastomosis', 'description': 'Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis', 'interventionNames': ['Procedure: Resection and anastomosis']}, {'type': 'EXPERIMENTAL', 'label': 'NG-SV mesosigmoidopexy', 'description': 'Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy', 'interventionNames': ['Procedure: Mesosigmoidopexy']}], 'interventions': [{'name': 'Resection and anastomosis', 'type': 'PROCEDURE', 'description': 'Resection of sigmoid colon with primary anastomosis', 'armGroupLabels': ['G-SV Resection and anastomosis', 'NG-SV resection and anastomosis']}, {'name': 'Resection and colostomy', 'type': 'PROCEDURE', 'description': "Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure", 'armGroupLabels': ['G-SV Resection and colostomy']}, {'name': 'Mesosigmoidopexy', 'type': 'PROCEDURE', 'description': 'Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.', 'armGroupLabels': ['NG-SV mesosigmoidopexy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Kamuzu Central Hospital', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Jonathan C Samuel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}