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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000011339 |
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Date of registration:
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01/08/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
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Scientific title:
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Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery - Clinical study of laparoscopic rectal resection / amputation for rectal tumor using robot assisted surgery |
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Date of first enrolment:
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2013/08/16 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013285 |
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Study type:
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Observational |
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Study design:
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Not selected Not selected
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Phase:
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Phase I
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Countries of recruitment
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Japan
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Contacts
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Name:
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Akinobu Taketomi |
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Address:
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N14W5 Kita-Ku Sapporo
Japan |
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Telephone:
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011-706-5927 |
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Email:
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Affiliation:
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Hokkaido University Hospital Gastroenterological Surgery I |
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Name:
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Shigenori Homma |
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Address:
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N14W5 Kita-Ku Sapporo
Japan |
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Telephone:
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011-706-5927 |
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Email:
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Affiliation:
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Hokkaido University Hospital Gastroenterological Surgery I |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Patients with pelvic surgery history by laparotomy. 2.Other organs invasive rectal cancer patients. 3.Lateral lymph node metastasis. 4.Patients with a history colon, rectal cancer, excluding mucosal cancer. 5.Patient with investigator has determined to be inappropriate as a subject.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Rectal tumor
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Primary Outcome(s)
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1.Conversion to laparotomy 2.Conversion to conventional laparoscopy
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Secondary Outcome(s)
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1.Intra-operative complication 2.Post-operative complication 3.Pathological positive rate of circumferential resection margin 4.Urinary dysfunction 5.Sexual dysfunction 6.3 years rate of local recurrence
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Source(s) of Monetary Support
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Hokkaido University Hospital
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/07/2018 |
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URL:
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