UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
Title of the study (Brief title)	Clinical study of laparoscopic rectal resection / amputation for rectal tumor using robot assisted surgery
Region	Japan

Condition
Condition	Rectal tumor
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clinical study of the safety for laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	1.Conversion to laparotomy 2.Conversion to conventional laparoscopy
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Over 20 years old patient at the time of informed consent. 2.Rectal Tumor, histologically. 3.Performance Status (ECOG) is 0-1. 4.Patients who obtained the document voluntary consent of the patient himself after receiving a sufficient explanation upon participation in this study , on a full understanding.
Key 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.
Target sample size	10

Research contact person
Name of lead principal investigator	Akinobu Taketomi
Organization	Hokkaido University Hospital
Division name	Gastroenterological Surgery I
Address	N14W5 Kita-Ku Sapporo
TEL	011-706-5927
Email

Public contact
Name of contact person	Shigenori Homma
Organization	Hokkaido University Hospital
Division name	Gastroenterological Surgery I
Address	N14W5 Kita-Ku Sapporo
TEL	011-706-5927
Homepage URL
Email

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道大学病院(Hokkaido University Hospital)

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 15 Day
Anticipated trial start date	2013 Year 08 Month 16 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded	2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1.Conversion to laparotomy 2.Conversion to conventional laparoscopy 3.Intra-operative complication 4.Post-operative complication 5.Pathological positive rate of circumferential resection margin 6.Urinary dysfunction 7.Sexual dysfunction 8.3 years rate of local recurrence

Management information
Registered date	2013 Year 08 Month 01 Day
Last modified on	2018 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013285