Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 2:16 AM
Study NCT ID:
NCT01130233
Status:
UNKNOWN
Last Update Posted:
2010-05-25
First Post:
2010-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial on Robotic Assisted Resection for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-24', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bladder function', 'timeFrame': 'one year', 'description': 'Urodynamic Questionnaire'}], 'secondaryOutcomes': [{'measure': 'tumor status', 'timeFrame': 'One year', 'description': 'recurrence and survival'}, {'measure': 'Quality of life', 'timeFrame': 'one year', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rectal cancer'], 'conditions': ['Rectal Cancer', 'Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery\n\nThis is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.', 'detailedDescription': 'This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer\n\nThe primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.\n\nThe secondary outcome measures include\n\n1. The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;\n2. The quality of life of the patients and the cost of the two groups\n3. The quality of the resected specimens\n4. The local recurrence rates at two years after the surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge\n2. Age \\>18 years\n3. Informed consent obtained\n4. American Society of Anesthesiologist class 1-3\n5. No contraindication to laparoscopic surgery\n6. Acceptable operating risk\n\nExclusion Criteria:\n\n1. Locally advanced fixed tumor with the need for exenterative surgery\n2. Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous\n3. Multiple previous operations with the anticipation of dense peritoneal adhesions\n4. No informed consent'}, 'identificationModule': {'nctId': 'NCT01130233', 'briefTitle': 'Randomized Trial on Robotic Assisted Resection for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer', 'orgStudyIdInfo': {'id': 'UW 09-132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'robotic', 'description': 'robotic assisted rectal resection', 'interventionNames': ['Procedure: robotic assisted rectal resection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic', 'description': 'laparoscopic rectal resection', 'interventionNames': ['Procedure: laparoscopic rectal resection']}], 'interventions': [{'name': 'robotic assisted rectal resection', 'type': 'PROCEDURE', 'description': 'robotic assisted rectal resection', 'armGroupLabels': ['robotic']}, {'name': 'laparoscopic rectal resection', 'type': 'PROCEDURE', 'description': 'laparoscopic rectal resection', 'armGroupLabels': ['laparoscopic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Wai Lun LAW, MBBS, MS', 'role': 'CONTACT', 'email': 'lawwl@hkucc.hku.hk', 'phone': '+852 22554763'}, {'name': 'Wai Lun Law, MBBS, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Wai Lun Law, MBBS, MS', 'role': 'CONTACT', 'email': 'lawwl@hkucc.hku.hk', 'phone': '+852 22554763'}], 'overallOfficials': [{'name': 'Wai Lun Law, MBBS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Wai Lun LAW', 'oldOrganization': 'The University of Hong Kong'}}}}