Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-04-15 @ 3:02 AM
Study NCT ID:
NCT01786694
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2013-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Microdialysis by Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal 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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2013-02-01', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional success of microdialysis', 'timeFrame': 'postoperative day 5', 'description': 'the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter'}], 'secondaryOutcomes': [{'measure': 'anastomotic leaks rate', 'timeFrame': 'postoperative day 30', 'description': 'the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan'}, {'measure': 'superficial surgical site infection rate', 'timeFrame': 'postoperative day 30', 'description': 'the surgical site infection rate is defined as the number of infection near the incision'}, {'measure': 'the mortality rate', 'timeFrame': 'postoperative day 30', 'description': 'the mortality rate is defined as the number of death after the surgery'}, {'measure': 'the quality of life after the surgery', 'timeFrame': 'postoperative day 30', 'description': 'the quality of life will be evaluated with the QLQ C30 CR 29 prior to the surgery, at the hospital discharge and on postoperative day 30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rectum', 'microdialysis', 'quality of life'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '22103734', 'type': 'BACKGROUND', 'citation': 'Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.'}, {'pmid': '18500500', 'type': 'BACKGROUND', 'citation': 'Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24.'}, {'pmid': '17122625', 'type': 'BACKGROUND', 'citation': 'Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rectal disease requiring proctectomy with anastomosis and stomy\n* proctectomy by laparoscopy\n* written consent\n\nExclusion Criteria:\n\n* history of colorectal surgery\n* rectal surgery without anastomosis\n* breastfeeding or pregnancy\n* ASA score IV'}, 'identificationModule': {'nctId': 'NCT01786694', 'acronym': 'MTM-COLON-I', 'briefTitle': 'Feasibility of Microdialysis by Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Feasibility of Microdialysis by Laparoscopy', 'orgStudyIdInfo': {'id': 'PI2012_843_0022'}, 'secondaryIdInfos': [{'id': '2012-A01218-35', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cma microdialysis catheter placement', 'description': 'At the end of the surgery the cma microdialysis catheter is placed near the anastomosis', 'interventionNames': ['Device: cma microdialysis catheter placement']}], 'interventions': [{'name': 'cma microdialysis catheter placement', 'type': 'DEVICE', 'description': 'the microdialysis catheters are sold by CMA', 'armGroupLabels': ['cma microdialysis catheter placement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'Amiens University Hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'jean marc regimbeau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}