Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-05 @ 7:46 AM
Study NCT ID:
NCT02830633
Status:
UNKNOWN
Last Update Posted:
2016-07-13
First Post:
2016-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-09', 'studyFirstSubmitDate': '2016-06-12', 'studyFirstSubmitQcDate': '2016-07-09', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.', 'timeFrame': 'postoperative 30 days'}, {'measure': 'The postoperative sexual function assessed by IIEF questionnaire', 'timeFrame': 'postoperative one year'}, {'measure': 'The postoperative voiding function assessed by IPSS questionnaire.', 'timeFrame': 'postoperative one year'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'an expected average of 180 minutes'}, {'measure': 'Postoperative deaths', 'timeFrame': 'postoperative 30 days'}, {'measure': 'The length postoperative hospital stay', 'timeFrame': 'an expected average 8 days'}, {'measure': 'C-reactive protein', 'timeFrame': 'postoperative 7 days', 'description': 'serum C-reactive protein level after operation'}]}, 'conditionsModule': {'keywords': ['laparoscopy', 'rectal cancer', 'pelvic autonomic nerve'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '29682715', 'type': 'DERIVED', 'citation': 'He Y, Zhu Z, Liu S, Liu L, Hu B, Wan X, Huang Q. [Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Apirl 25;21(4):431-436. Chinese.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male patients\n2. From 18 years old to 60 years old\n3. Normal sexual function\n4. Tumor located in rectum (defined as 5- to 12-cm from the anal verge)\n5. Pathological confirmed rectal cancer\n6. Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual\n7. Tumor size \\< 5 cm\n8. ASA score was I-II\n9. Informed consent was written\n\nExclusion Criteria:\n\n1. Distant cancer metastasis\n2. History of abdominal surgery\n3. With other type of malignancy\n4. Preoperative voiding dysfunction\n5. Preoperative sexual dysfunction\n6. Refusing to attend this trial'}, 'identificationModule': {'nctId': 'NCT02830633', 'briefTitle': 'Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Medical University'}, 'orgStudyIdInfo': {'id': 'LNTME-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LNTME', 'description': 'Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients', 'interventionNames': ['Procedure: LNTME']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OTME', 'description': 'Open TME (OTME) is conducted in rectal cancer patients', 'interventionNames': ['Procedure: OTME']}], 'interventions': [{'name': 'LNTME', 'type': 'PROCEDURE', 'description': 'Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer', 'armGroupLabels': ['LNTME']}, {'name': 'OTME', 'type': 'PROCEDURE', 'description': 'Patients in this group received traditional open TME for treatment of rectal cancer', 'armGroupLabels': ['OTME']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Han-Hui HH YAO, M.D.', 'role': 'CONTACT', 'email': 'ruoyubaba@163.com', 'phone': '+86-18956087855'}, {'name': 'Liu L LIU, PhD', 'role': 'CONTACT', 'email': 'liuwkjy@126.com', 'phone': '+86-15056017712'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Han-Hui YAO', 'investigatorAffiliation': 'Anhui Medical University'}}}}