Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-28 @ 12:44 AM
Study NCT ID:
NCT03325361
Status:
UNKNOWN
Last Update Posted:
2017-10-30
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic leakage', 'timeFrame': '30 days', 'description': 'Prevention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer', 'Rectal Neoplasms', 'Anastomotic Leak']}, 'descriptionModule': {'briefSummary': 'Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.', 'detailedDescription': "Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.\n\nPatients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer\n\nExclusion Criteria:\n\n* No anastomosis'}, 'identificationModule': {'nctId': 'NCT03325361', 'briefTitle': 'The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage', 'orgStudyIdInfo': {'id': 'Transanal Tube Drainage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TD', 'interventionNames': ['Other: Tube drain insertion']}, {'type': 'NO_INTERVENTION', 'label': 'NTD'}], 'interventions': [{'name': 'Tube drain insertion', 'type': 'OTHER', 'description': 'A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.', 'armGroupLabels': ['TD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pierpaolo Sileri', 'role': 'CONTACT', 'phone': '3209353441'}], 'facility': 'Policlinico Tor Vergata Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Pierpaolo Sileri, PhD', 'role': 'CONTACT', 'email': 'piersileri@yahoo.com', 'phone': '3209353441'}, {'name': 'Mostafa Shalaby, PhD', 'role': 'CONTACT', 'email': 'shalaby-mostafa@hotmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pierpaolo Sileri', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}