UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Title of the study (Brief title)	Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of laparoscopic lateral lymph node dissection.
Basic objectives2	Others
Basic objectives -Others	Observational Study
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety; rate of Grade 3 or 4 adverse events
Key secondary outcomes	Blood loss, Operation time, sexual function, urinary function, relapse free survival rate, and overall survival rate

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Rectal cancer is proved histologically by biopsy of rectal primary tumor. 2. Preoperative findings indicate clinical stage II or III.
Key exclusion criteria	1. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2. Cases with uncontrollable diabetes 3. Cases with uncontrollable congestive heart failure, angina pectoris, hypertension, arrhythmia 4. It is judged that psychosis or psychiatric symptoms are merged and it is difficult to participate in the study. 5. In addition, it is a case that the doctor in charge judged that registration of this study is inappropriate.
Target sample size	90

Research contact person
Name of lead principal investigator	Junichi Nishimura
Organization	Osaka International Cancer Institute
Division name	Department of Gastroenterological surgery
Address	541-8567 Ohteme 3-1-69, Osaka, Osaka, Japan
TEL	0669451181
Email	jnishimura@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Junichi Nishimura
Organization	Osaka International Cancer Institute
Division name	Department of Gastroenterological surgery
Address	541-8567 Ohteme 3-1-69, Osaka, Osaka, Japan
TEL	0669451181
Homepage URL
Email	jnishimura@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Multi-Center Clinical Study Group of Osaka; Colorectal Cancer Treatment Group (MCSGO)
Institute
Department

Funding Source
Organization	SCCRE
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 17 Day
Anticipated trial start date	2018 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Not yet

Management information
Registered date	2018 Year 07 Month 10 Day
Last modified on	2018 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038023