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ISRCTN
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ISRCTN12189372
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DOI
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10.1186/ISRCTN12189372
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Level of arterial ligation in rectal cancer surgery
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Scientific title
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Oncological and surgical outcome after high versus low ligation of inferior mesenteric artery during curative surgery from rectal cancer
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Oncological and surgical outcome after ligation and division of superior rectal artery just beneath the origin of left colic artery (low tie) is not inferior than after ligation of inferior mesenteric artery at its origin (high tie) during curative surgery for rectal cancer.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Bioethics for Research Committee of Medical Univeristy of Gdañsk, Poland ref: NKEBN/373/2009
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Study design
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Randomised trial
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Countries of recruitment
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Poland
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Disease/condition/study domain
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Rectal cancer suitable for curative R0 resection with or without prior neoadiuvant treatment
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Participants - inclusion criteria
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1. Adult patient with the history of any other neoplasm than rectal and skin cancer
2. Any history of colorectal surgery except the laparoscopic ileostomy in patient awaiting for radical treatment of rectal cancer.
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Participants - exclusion criteria
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1. Urgent operation
2. Potentially unresectable disease
3. Comorbid condtions excluding the possibility of standard therapy
4. T4 tumour
5. Any other malignant neoplasm except skin cancer
6. Synchronic distant metastases
7. Lack of patient consent for participation in the study
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Anticipated start date
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01/04/2011
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Anticipated end date
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30/06/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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At least 120 (one hundred and twenty)
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Interventions
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The ligation and division of inferior mesenteric artery at its origin from aorta or just beneath the origin of the left colic artery from inferior mesenteric artery during curative R0 resection from rectal cancer.
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Primary outcome measure(s)
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1. Postoperative mortality and morbidity (special reference to the rate of clinical anastomotic leakage)
2. The need for splenic flexure mobilization
3. The number of lymph nodes resected and their pathological estimation
4. Need for blood transfusion
5. Time to disease recurrence
6. Way of spread of disease
7. Cancer related death rate
8. Overall survival
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Secondary outcome measure(s)
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1. Permanent stoma rate
2. The rate of stoma reversal
3. Quality of life (QLQ C30 questionnaire)
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Sources of funding
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Foundation for the Development of Surgery [Fundacja na Rzecz Rozwoju Chirurgii] (Poland)
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Trial website
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Publications
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Contact name
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Prof
Wieslaw
Kruszewski
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Address
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Maritime Hospital
Gdynia Centre of Oncology
Powstania Styczniowego 1
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City/town
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Gdynia
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Zip/Postcode
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81-519
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Country
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Poland
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Tel
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+48 587 260 250
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Fax
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+48 587 260 250
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Email
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wjkrusz@gumed.edu.pl
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Sponsor
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Maritime Hospital (Poland)
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Address
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Gdynia Centre of Oncology
81-519 Gdynia
Powstania Styczniowego 1
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City/town
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Gdynia
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Zip/Postcode
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1
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Country
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Poland
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Sponsor website:
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http://www.szpital-morski.pl
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Date applied
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09/11/2012
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Last edited
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18/12/2012
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Date ISRCTN assigned
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18/12/2012
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