Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT04037956
Status:
RECRUITING
Last Update Posted:
2022-03-31
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 458}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-28', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease free survival rate', 'timeFrame': '36 months after surgery'}], 'secondaryOutcomes': [{'measure': '5-year overall survival rate', 'timeFrame': '60 months after surgery'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': '1 month after surgery', 'description': 'All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.'}, {'measure': 'the functional outcome of defecation', 'timeFrame': '60 months after surgery', 'description': "Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle)."}, {'measure': 'the operation time', 'timeFrame': 'in the perioperative period', 'description': 'The descriptive unit would be minute (min).'}, {'measure': 'the blood loss during the operation', 'timeFrame': 'in the perioperative period', 'description': 'The descriptive unit would be millilitre (ml)'}, {'measure': 'Postoperative recovery of intestinal peristalsis', 'timeFrame': 'in the perioperative period', 'description': 'The descriptive unit would be hour (h).'}, {'measure': 'Pain score', 'timeFrame': 'in the perioperative period', 'description': 'A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).'}, {'measure': 'number of cases converted to laparotomy', 'timeFrame': 'in the perioperative period', 'description': 'The procedure for cases who underwent traditional laparoscopic radical resection for those who cannot be done with traditional laparoscopic radical resection or Tubless NOSES and convert to laparotomy as a result，these should be recorded and compared within two experimental arms.'}, {'measure': 'the mean postoperative hospitalization day', 'timeFrame': 'in the perioperative period', 'description': 'The descriptive unit would be day (d).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tubeless NOSES', 'traditional laparoscopic radical resection', 'Rectosigmoid Cancers'], 'conditions': ['Tubeless NOSES', 'Traditional Laparoscopic Radical Resection', 'Rectosigmoid Cancers']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.', 'detailedDescription': 'This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed Rectosigmoid Cancers\n2. Clinical stage at T 1-3 N0-2 M0\n3. Tumors on peritoneal reflection，Tumor size is no more than 3 cm\n4. Eastern Cooperative Oncology Group (ECOG) scale is 0-2\n5. American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ\n6. BMI ≤ 30 kg/m2\n7. Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.\n\nExclusion Criteria:\n\n1. Heart, lung, liver or renal or any organ function that are intolerance for surgery\n2. History of treated colorectal malignant disease\n3. Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery\n4. Subjects with previous malignancies\n5. History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)\n6. Treatment with any other clinical trial within 28 days prior to randomization\n7. History of severe mentally disease\n8. pregnant or lactating women\n9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.'}, 'identificationModule': {'nctId': 'NCT04037956', 'acronym': 'CORNER', 'briefTitle': 'Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)', 'orgStudyIdInfo': {'id': 'SixthSunYetSen-Lyx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tubeless NOSES', 'description': 'Patients receive Tubeless NOSES.', 'interventionNames': ['Procedure: Tubeless NOSES']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional laparoscopic', 'description': 'Patients receive traditional laparoscopic radical resection.', 'interventionNames': ['Procedure: traditional laparoscopic radical resection']}], 'interventions': [{'name': 'Tubeless NOSES', 'type': 'PROCEDURE', 'description': 'The whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal).', 'armGroupLabels': ['Tubeless NOSES']}, {'name': 'traditional laparoscopic radical resection', 'type': 'PROCEDURE', 'description': 'The traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen.', 'armGroupLabels': ['traditional laparoscopic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanxin Luo, PhD,MD', 'role': 'CONTACT', 'email': 'luoyx25@mail.sysu.edu.cn', 'phone': '86-13826190263'}, {'name': 'Jinxin Lin, PhD,MD', 'role': 'CONTACT', 'email': 'linjx69@mail2.sysu.edu.cn', 'phone': '86-18998815200'}], 'facility': 'The Sixth Affiliate Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yanxin Luo, MD，PHD', 'role': 'CONTACT', 'email': 'luoyx25@mail.sysu.edu.cn', 'phone': '86-13826190263'}, {'name': 'Jinxin Lin, MD，PHD', 'role': 'CONTACT', 'email': 'linjx69@mail2.sysu.edu.cn', 'phone': '86-18998815200'}], 'overallOfficials': [{'name': 'Yanxin Luo, phD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Sixth Affiliate Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Yanxin Luo,MD', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}