Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02626728
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Feasibility Study for TAMIS
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067368', 'term': 'Transanal Endoscopic Surgery'}], 'ancestors': [{'id': 'D057605', 'term': 'Natural Orifice Endoscopic Surgery'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011351', 'term': 'Proctoscopy'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbidity', 'timeFrame': '30-days', 'description': 'Clavien-Dindo'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '30-days', 'description': 'death within 30-days'}, {'measure': 'short-term oncological result', 'timeFrame': '30-days', 'description': 'cancer-free resection margins'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and distant metastasis, will be offered the operative procedure with TAMIS technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* rectal cancer with histological diagnosis\n* tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope.\n* suitable for elective resection\n\nexclusion criteria:\n\n* preoperative magnetic resonance imaging (MRI) showing diameter of tumor size \\>6 cm\n* American Society of Anesthesiologists (ASA) class IV and V\n* anticipated need of intensive care unit (ICU)\n* history of previous major abdominal surgery\n* computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs\n* obese patient with body mass index \\>35kg/m2\n* those, who do not understand the requirements of the protocol\n* pregnancy\n* more than one colorectal tumor'}, 'identificationModule': {'nctId': 'NCT02626728', 'acronym': 'TAMIS', 'briefTitle': 'A Prospective Feasibility Study for TAMIS', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'A Prospective Quality Assurance Feasibility Study of Laparoscopic Assisted Transanal Minimally Invasive Surgery (TAMIS) for Rectal Cancer', 'orgStudyIdInfo': {'id': '123-TAMIS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscopic assisted transanal surgery (TAMIS)', 'type': 'PROCEDURE', 'description': 'all patients included recieve laparoscopic assisted transanal minimally invasive surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital University of Copenhagen', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Mette W Christoffersen, M.D, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hvidovre Hospital University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, PhD', 'investigatorFullName': 'Mette Willaume Christoffersen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}