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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002909
Receipt No. R000003546
Scientific Title Prospective cohort study of laparoscopic low anterior resection for the patients with advanced rectal cancer
Date of disclosure of the study information 2009/12/17
Last modified on 2017/06/24

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Basic information
Public title Prospective cohort study of laparoscopic low anterior resection
for the patients with advanced rectal cancer
Acronym MCSGO-0902
Scientific Title Prospective cohort study of laparoscopic low anterior resection
for the patients with advanced rectal cancer
Scientific Title:Acronym MCSGO-0902
Region
Japan

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

Objectives
Narrative objectives1 This study aimed to prospectively evaluate operative safety and short-term oncologic outcomes in laparoscopic low anterior resection for the patients with advanced rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes completion rate of laparoscopic surgery
Key secondary outcomes

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) daiagnosed with rectal adenocarcinoma histologically
2) distal edge of tumor is located in the middle third of the rectum (7-12cm from anal verge)
3) cT3 or cT4, tumor size within 5cm, and without adjacent organ involvement
4) cN0, cN1, or cN2
5) cM0
6) elective surgery case
7) without any previous abdominal surgery (except the appendectomy)
8) BMI less than 30
9) without any irradiation for the pelvis
10) written informed consent
Key exclusion criteria 1) synchronous colorectal carcinoma
2) pregnancy or lactaiton
3) complicated with psychosis
4) myocardial infarction within six months or unstable angina
5) severe pulmonary emphysema or pulmonary fibrosis
6) uneder systemic steroid therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsugu Sekimoto
Organization Osaka University
Graduate School of Medicine
Division name Department of Surgery
Zip code
Address Yamadaoka 2-2, Suita, Osaka
TEL 06-6879-3251
Email msekimoto@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Ikeda Tsunekazu Mizushima
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address Yamadaoka 2-2 E2, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.lww.com/surgical-laparoscopy/Abstract/2017/04000/Tumor_Size_as_an_Independent_Risk_F
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study aimed to prospectively evaluate the operative outcomes, postoperative recovery, and short-term oncological results in laparoscopic low anterior resection for patients with advanced rectal cancer.

Management information
Registered date
2009 Year 12 Month 16 Day
Last modified on
2017 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003546

Research Plan
Registered date File name
2016/07/06 治癒切除不能・進行再発大腸癌における2次治療としてのXELOX+ベバシズマブ併用療法に関する有効性の検討.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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