Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-25 @ 6:17 AM
Study NCT ID:
NCT03911167
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2019-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D012371', 'term': 'Robotics'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complication rate，%', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Urine tube time,days;', 'timeFrame': '2 weeks'}, {'measure': 'operation time,minutes;', 'timeFrame': '2 weeks'}, {'measure': 'intraoperative bleeding,ml;', 'timeFrame': '2 weeks'}, {'measure': 'number of lymph node detection,', 'timeFrame': '2 weeks'}, {'measure': 'exhaust time,days;', 'timeFrame': '2 weeks'}, {'measure': 'intake time, days;', 'timeFrame': '2 weeks'}, {'measure': 'postoperative hospital stay,days;', 'timeFrame': '2 weeks'}, {'measure': 'hospitalization expenses,yuan', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': "A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Affiliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;\n* blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;\n* without distant metastasis such as liver, lung, bone, and abdominal cavity.\n\nExclusion Criteria:\n\n* there is distant organ transfer or extensive abdominal metastasis;\n* emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;\n* combined with other primary malignant tumors;\n* other colonectomy and combined with other organ resection;\n* patients with severe basic diseases unable to tolerate surgery;\n* pregnant and lactating women;\n* patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery;\n* those who underwent palliative surgery.'}, 'identificationModule': {'nctId': 'NCT03911167', 'briefTitle': 'An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer', 'orgStudyIdInfo': {'id': 'XJTU1AF2019LSK-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RG', 'description': 'RG: robotic group', 'interventionNames': ['Procedure: open, laparoscopic, and robotic']}, {'label': 'LG', 'description': 'LG:laparoscopic group,', 'interventionNames': ['Procedure: open, laparoscopic, and robotic']}, {'label': 'OG', 'description': 'OG：open group', 'interventionNames': ['Procedure: open, laparoscopic, and robotic']}], 'interventions': [{'name': 'open, laparoscopic, and robotic', 'type': 'PROCEDURE', 'description': 'Radical resection of rectal cancer in robotic, laparoscopic, and open approach', 'armGroupLabels': ['LG', 'OG', 'RG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}