Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-14 @ 2:44 AM
Study NCT ID:
NCT02812628
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 528}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Operative time for perineal dissection', 'timeFrame': '1 month post operation'}, {'measure': 'Numbers of days to remove the urinary catheter after surgery', 'timeFrame': '1 month post operation'}, {'measure': 'Circumferential Resection Margin (+) rate', 'timeFrame': '1 month post operation', 'description': 'circumferential resection margin positive rate'}, {'measure': 'Perforation rate', 'timeFrame': '1 month post operation', 'description': 'intraoperative perforation rate'}], 'primaryOutcomes': [{'measure': '3-year local recurrence', 'timeFrame': '3 years post operation'}], 'secondaryOutcomes': [{'measure': '3-year overall survival', 'timeFrame': '3 years post operation'}, {'measure': '3-year disease-free survival', 'timeFrame': '3 years post operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['laparoscopic surgery', 'abdominoperineal resection', 'rectal cancer', 'individualized surgery', 'levator muscle'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).', 'detailedDescription': 'In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.\n2. Patients undergoing elective, radial surgery with no distant metastasis.\n3. Patients with Body Mass Index (BMI) between 18-30kg/m2.\n4. Patients who agree to undergo standard adjuvant treatment after surgery.\n5. Patients who have fully understood the aim of the trial and have signed the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.\n2. Patients undergoing emergent surgery.\n3. Pregnant patients.\n4. Patients with tumors other than rectal tumor.\n5. Patients with severe comorbid diseases which preclude surgery.\n6. Patients in bad conditions and do not ameliorate before surgery.\n7. Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.\n8. Patients who refuse to accept standard adjuvant surgery.'}, 'identificationModule': {'nctId': 'NCT02812628', 'briefTitle': 'Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer', 'orgStudyIdInfo': {'id': 'MISC-APR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional LAPR', 'description': 'Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).', 'interventionNames': ['Procedure: LAPR']}, {'type': 'EXPERIMENTAL', 'label': 'LAPR-TILT', 'description': 'Patients undergoing LAPR with transabdominal individualized levator transection (TILT).', 'interventionNames': ['Procedure: LAPR-TILT']}], 'interventions': [{'name': 'LAPR', 'type': 'PROCEDURE', 'description': 'Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.', 'armGroupLabels': ['Conventional LAPR']}, {'name': 'LAPR-TILT', 'type': 'PROCEDURE', 'description': 'Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.', 'armGroupLabels': ['LAPR-TILT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Feng, MD/PhD', 'role': 'CONTACT', 'email': 'fengbo2022@163.com', 'phone': '86-21-64370045', 'phoneExt': '664566'}], 'facility': 'Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Bo Feng, M.D. Ph.D', 'role': 'CONTACT', 'email': 'fengbo2022@163.com', 'phone': '86-21-64370045'}], 'overallOfficials': [{'name': 'Bo Feng, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistent professor of surgery', 'investigatorFullName': 'Bo Feng', 'investigatorAffiliation': 'Ruijin Hospital'}}}}