Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-31 @ 10:20 AM
Study NCT ID:
NCT01766661
Status:
UNKNOWN
Last Update Posted:
2019-02-27
First Post:
2013-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative morbidity', 'timeFrame': 'within the first 30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '3 years', 'description': 'by COREFO questionnaire.'}, {'measure': 'Fecal incontinence', 'timeFrame': '3 years', 'description': 'by Wexner Incontinence Score'}, {'measure': 'local and/or distant recurrence of neoplasm', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rectal Neoplasm']}, 'referencesModule': {'references': [{'pmid': '38985480', 'type': 'DERIVED', 'citation': 'Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262.'}, {'pmid': '32492131', 'type': 'DERIVED', 'citation': 'Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19.'}, {'pmid': '28667499', 'type': 'DERIVED', 'citation': 'Biondo S, Trenti L, Galvez A, Espin-Basany E, Bianco F, Romano G, Kreisler E; Turnbull-BCN study group. Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN). Int J Colorectal Dis. 2017 Sep;32(9):1357-1362. doi: 10.1007/s00384-017-2842-4. Epub 2017 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.', 'detailedDescription': 'Anastomotic leak represents the most frequent complication after rectal cancer surgery and a lateral covering ileostomy is usually performed to reduce its incidence. Other important consequences of rectal cancer surgery are alterations in bowel habits and function and a negative impact on quality of life. This prospective, randomized, multicenter and controlled trial compares post-operative complications, quality of life, faecal incontinence and recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis;\n* Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment;\n* Patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention\n* Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification;\n* Patients with or without lymph node metastasis (N - / +) and with or without resectable distant metastases;\n* Patients clinically without fecal incontinence prior to the current illness and with a Wexner incontinence Score less than or equal to 5;\n* Patients ASA I, II or III and adequate hematological, renal and hepatic function;\n* Patients who signed informed consent.\n\nExclusion Criteria:\n\n* Altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write\n* Fecal incontinence (Wexner equal to or greater than 6);\n* Previous surgery or proctological, colonic and anorectal functional disease\n* Diagnosis of synchronous colorectal or any other active neoplasm;\n* Patients ASA IV, V;\n* Pregnancy and lactation;\n* Rejection of the patient to sign the consent form.'}, 'identificationModule': {'nctId': 'NCT01766661', 'acronym': 'TURNBULL-BCN', 'briefTitle': 'Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis', 'orgStudyIdInfo': {'id': 'TURNBULL-BCN-01'}, 'secondaryIdInfos': [{'id': 'PR174/11', 'type': 'OTHER', 'domain': 'CEIC Hospital Universitari de Bellvitge'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coloanal anastomosis with ileostomy', 'description': 'Hand-sewn coloanal anastomosis protected by a loop ileostomy', 'interventionNames': ['Procedure: Hand-sewn coloanal anastomosis', 'Procedure: Ultralow anterior rectal resection with total mesorectal excision']}, {'type': 'EXPERIMENTAL', 'label': 'Two stage Turnbull-Cutait anastomosis', 'description': 'Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).', 'interventionNames': ['Procedure: Two staged Turnbull-Cutait procedure', 'Procedure: Ultralow anterior rectal resection with total mesorectal excision']}], 'interventions': [{'name': 'Hand-sewn coloanal anastomosis', 'type': 'PROCEDURE', 'description': 'After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.', 'armGroupLabels': ['Coloanal anastomosis with ileostomy']}, {'name': 'Two staged Turnbull-Cutait procedure', 'type': 'PROCEDURE', 'description': 'After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.', 'armGroupLabels': ['Two stage Turnbull-Cutait anastomosis']}, {'name': 'Ultralow anterior rectal resection with total mesorectal excision', 'type': 'PROCEDURE', 'description': 'Standard ultralow anterior rectal resection with total mesorectal excision', 'armGroupLabels': ['Coloanal anastomosis with ileostomy', 'Two stage Turnbull-Cutait anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitària Parc Taulí Hospital Universitari', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron Universitary Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Bellvitge University Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Sebastiano Biondo, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bellvitge University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MD', 'investigatorFullName': 'Sebastiano Biondo', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}