Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT06409403
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': 'preoperation，1、3、6、12 months after operation', 'description': 'evaluation of genitourinary function'}], 'secondaryOutcomes': [{'measure': 'International Index of Erectile Function (IIEF)', 'timeFrame': 'preoperation，1、3、6、12 months after operation', 'description': 'evaluation of genitourinary function'}, {'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'preoperation，1、3、6、12 months after operation', 'description': 'evaluation of genitourinary function'}, {'measure': 'operative time', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}, {'measure': 'blood loose', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}, {'measure': 'conversion', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}, {'measure': 'retrieved lymph nodes', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}, {'measure': 'complete TME specimens', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}, {'measure': 'circumferential resection margins (CRMs)', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}, {'measure': 'complication', 'timeFrame': 'perioperative', 'description': 'operative outcomes'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. In particular, laparoscopic TME (L-TME) is technically difficult and requires advanced laparoscopic surgical skills. Comparing with the conventional laparoscopic approach, 3D vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the PAN during robotic-assisted TME (R-TME), theoretically facilitating favourable recovery of postoperative genitourinary function. Previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. However, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. Consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. Hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic MRI and CT scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) American Society of Anesthesiology (ASA) class ≤3\n\nExclusion Criteria: Benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (International Index of Erectile Function (IIEF) score \\<10 or Female Sexual Function Index (FSFI) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.'}, 'identificationModule': {'nctId': 'NCT06409403', 'briefTitle': 'Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Third Xiangya Hospital of Central South University'}, 'officialTitle': 'Study on Clinical Application of Robotic Technique', 'orgStudyIdInfo': {'id': 'YB2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'da Vinci robotic TME', 'interventionNames': ['Device: clinical application of robotic technique']}, {'type': 'EXPERIMENTAL', 'label': 'Microhands robotic TME', 'interventionNames': ['Device: clinical application of robotic technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic surgery TME', 'interventionNames': ['Device: clinical application of robotic technique']}], 'interventions': [{'name': 'clinical application of robotic technique', 'type': 'DEVICE', 'description': 'effect of various surgical technique on clinical efficacy of TME', 'armGroupLabels': ['Microhands robotic TME', 'da Vinci robotic TME', 'laparoscopic surgery TME']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Yi, MD', 'role': 'CONTACT', 'email': '1459082987@qq.com', 'phone': '13786179533'}, {'name': 'Bo Yi, MD', 'role': 'CONTACT', 'email': 'yibo2018pro@126.com', 'phone': '13786179533'}, {'name': 'Bo Yi, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Bo Yi, MD', 'role': 'CONTACT', 'email': 'yibo2018pro@126.com', 'phone': '13786179533'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'general surgery 3', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Gastrointestinal Surgery', 'investigatorFullName': 'general surgery 3', 'investigatorAffiliation': 'The Third Xiangya Hospital of Central South University'}}}}