UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033355
Receipt No. R000038023
Official scientific title of the study Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.