Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT06814093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
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': 'D065287', 'term': 'Robotic Surgical Procedures'}, {'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2702}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year postoperative disease-free survival rate', 'timeFrame': 'From surgery to three years postoperatively', 'description': 'Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.'}], 'secondaryOutcomes': [{'measure': 'Circumferential resection margin positivity rate', 'timeFrame': '14 days during postoperative pathological examination', 'description': 'Circumferential resection margin positivity is defined as 1 mm or less from the tumor.'}, {'measure': '30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)', 'timeFrame': 'From surgery to 30 days postoperatively', 'description': '30-day postoperative complication rate is defined according to the Clavien-Dindo grade system. Only complications in grade 2 or higher grade will be calculated.'}, {'measure': 'rate of abdominoperineal resection', 'timeFrame': '30 days after surgery', 'description': 'percentage of patients received abdominoperineal resection'}, {'measure': '3-year postoperative locoregional recurrence rate', 'timeFrame': 'From surgery to three years postoperatively', 'description': 'Locoregional recurrence is defined as any cancer recurrence in the pelvic or perineal area.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The data is sourced from the Colorectal Cancer Specialty Cohort Database and Biobank, established through the "Construction and Application of the Shanghai Colorectal Cancer Specialty Cohort Database and Biobank" project. The research will utilize cohort data collected from January 2021 to May 2022 (17 months). This specialized database was led by Zhongshan Hospital, Fudan University, in collaboration with Shanghai Tenth People\'s Hospital, Fudan University Shanghai Cancer Center, First Affiliated Hospital of Naval Medical University (Changhai Hospital), Renji Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai First People\'s Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age from 18 years to 80 years;\n2. American Society of Anesthesiologists (ASA) class I - III;\n3. Histologically proved rectal adenocarcinoma;\n4. Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;\n5. Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;\n6. No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc;\n7. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;\n8. Received either robotic or laparoscopic surgery; 9） Surgery with radical intent;\n\n10\\) Informed consent.\n\nExclusion criteria\n\n1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;\n2. Synchronous colon surgery for multiple colorectal tumors or other schedules;\n3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);\n4. Co-existent inflammatory bowel disease;\n5. Pregnancy or lactation;\n6. Patients received treatment other than preoperative radio- or chemoradiotherapy.'}, 'identificationModule': {'nctId': 'NCT06814093', 'briefTitle': 'Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial', 'orgStudyIdInfo': {'id': 'CCS-DASET-TTE-REAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic group', 'description': 'Patients received robotic surgery for middle and low rectal cancer', 'interventionNames': ['Procedure: Robotic surgery']}, {'label': 'Laparoscopic group', 'description': 'Patients received laparoscopic surgery for middle and low rectal cancer', 'interventionNames': ['Procedure: Laparoscopic surgery']}], 'interventions': [{'name': 'Robotic surgery', 'type': 'PROCEDURE', 'description': 'Robotic surgery for radical resection of middle and low rectal cancer', 'armGroupLabels': ['Robotic group']}, {'name': 'Laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'Laparoscopic surgery for radical resection of middle and low rectal cancer', 'armGroupLabels': ['Laparoscopic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University, Shanghai, China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xu jianmin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Colorectal Surgery', 'investigatorFullName': 'Xu jianmin', 'investigatorAffiliation': 'Fudan University'}}}}