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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013919
Receipt No. R000016224
Scientific Title Open versus laparoscoic surgery for advanced low rectal cancer patients
Date of disclosure of the study information 2014/05/13
Last modified on 2017/03/30

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Basic information
Public title Open versus laparoscoic surgery for advanced low rectal cancer patients
Acronym Open versus laparoscoic surgery for advanced low rectal cancer patients
Scientific Title Open versus laparoscoic surgery for advanced low rectal cancer patients
Scientific Title:Acronym Open versus laparoscoic surgery for advanced low rectal cancer patients
Region
Japan

Condition
Condition low rectal cancer
Classification by specialty
Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the short-term and long-term outcomes of laparoscopic surgery for Stage II/III low rectal cancer compared with open surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes the incidence rates of postoperative adverse events
Key secondary outcomes 1)recurrence free survival
2)overall survival
3)local recurrence rates
4)recovery process after surgery

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)patients with clinical stage II/III low rectal cancer
2)patients who underwent primary rectal cancer resection
3)patients with preoperative radiation and/or chemotherapy are eligible
Key exclusion criteria 1)Patients with multiple primary cancers
2)Patients with treatment history for other pelvic malignancy
3)robotic surgery cases
Target sample size 2400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Sakai
Organization Kyoto University
Division name Department of Surgery
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-366-7595
Email ysakai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koya Hida
Organization Kyoto University
Division name Department of Surgery
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-366-7595
Homepage URL
Email hidakoya@kuhp.kyoto-u.ac.jp

Sponsor
Institute Japan Society of Laparoscopic Colorectal Surgery
Institute
Department

Funding Source
Organization The Japanese Foundation for Research and Promotion of Endoscopy, and The Japan Society of Clinical Oncology
Organization
Division
Category of Funding Organization Other
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 腹腔鏡下大腸切除研究会所属施設
(Institutions of the Japan Society of Laparoscopic Colorectal Surgery)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Laparoscopic surgery could be considered as a treatment option for advanced, low rectal cancer below the peritoneal reflection, based on the short-term and long-term
results of this large cohort study.
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
2014 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 31 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 11 Month 20 Day
Date analysis concluded
2016 Year 11 Month 01 Day

Other
Other related information Multicenter retrospective study

Management information
Registered date
2014 Year 05 Month 09 Day
Last modified on
2017 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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