Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-28 @ 4:36 AM
Study NCT ID:
NCT06326892
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infections (SSI)', 'timeFrame': '30 days after surgery', 'description': 'Rate difference of 30-day Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC) \\[Ref\\]- between the study cohorts.'}], 'secondaryOutcomes': [{'measure': 'Opioid rescue', 'timeFrame': 'From the date of surgery to the date of discharge', 'description': 'Difference in the proportion of patients requiring opioid rescue during the hospitalization'}, {'measure': 'Postoperative pain', 'timeFrame': '72 hours after surgery', 'description': 'The median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS)'}, {'measure': 'Postoperative ileus', 'timeFrame': '30 days after surgery', 'description': 'Rate difference of 30-day postoperative functional ileus (define as the absence of bowel function for at least three days)'}, {'measure': 'Incisional hernia', 'timeFrame': '6 months after surgery', 'description': 'The rate difference of six-month incisional hernia'}, {'measure': 'Overall postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'The rate difference of overall 30-day postoperative complications, classified according to the Clavien-Dindo scale \\[ranging from 0 (no complications) to 5 (complications leading to death)\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal Cancer', 'Natural Orifice Specimen Extraction', 'Propensity score matched'], 'conditions': ['Rectal Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction.', 'detailedDescription': 'Natural Orifice Specimen Extraction (NOSE) in colorectal surgery allows the extraction of the surgical specimen through the anal orifice. Several studies demonstrated improved postoperative pain, bowel movements, patient-reported cosmetic satisfaction, and psychological wellbeing after NOSE compared with traditional Pfannenstiel extraction. However, most of these studies focused on colon surgery. The aim of this retrospective propensity score matched study is to investigate the postoperative outcomes of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with low rectal cancer to the English National Low Rectal Cancer Development Programme (LOREC) who underwent low rectal resection with Total Mesorectal Excision (TME)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer between January 2017 and January 2023\n* Patients with rectal cancer classified as "low" according to the English National Low Rectal Cancer Development Programme (LOREC)\n\nExclusion Criteria:\n\n* Patients undergoing non-restorative procedures\n* Patients undergoing immediate or delayed handsewn coloanal anastomosis\n* Patients undergoing planned open surgery or unplanned conversion from minimally invasive to open surgery\n* Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD)'}, 'identificationModule': {'nctId': 'NCT06326892', 'acronym': 'NOSES', 'briefTitle': 'Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery', 'orgStudyIdInfo': {'id': 'CHR1-101-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Natural Orifice Specimen Extraction (NOSE)', 'description': 'Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE)', 'interventionNames': ['Procedure: Natural Orifice Specimen Extraction (NOSE)']}, {'label': 'Controls', 'description': 'Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction', 'interventionNames': ['Procedure: Traditional specimen extraction']}], 'interventions': [{'name': 'Natural Orifice Specimen Extraction (NOSE)', 'type': 'PROCEDURE', 'description': 'Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)', 'armGroupLabels': ['Natural Orifice Specimen Extraction (NOSE)']}, {'name': 'Traditional specimen extraction', 'type': 'PROCEDURE', 'description': 'Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}, {'name': 'Stefano De Zanet, MS', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 4623', 'phoneExt': '0039'}], 'facility': 'IRCCS Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}, {'name': 'Stefano De Zanet, MS', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 4623', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'Antonino Spinelli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Huamanitas Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}