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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017503
Receipt No. R000020285
Scientific Title Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR)
Date of disclosure of the study information 2015/05/12
Last modified on 2018/11/13

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Basic information
Public title Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR)
Acronym Clinical research of the Colorectal LECS
Scientific Title Clinical research of the laparoscopy endoscopy cooperative colorectal wedge resection (LECS-CR)
Scientific Title:Acronym Clinical research of the Colorectal LECS
Region
Japan

Condition
Condition colorectal submucosal tumor, colorectal adenoma, colorectal mucosal adenocarcinoma
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect and feasibility
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of anastomotic leakage
Key secondary outcomes Operation time, Estimated blood loss, Postoperative hospital stay, Postoperative diet starting day, Postoperative bowel movement starting day,
CRP at 1POD,
Resection margin positive rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Operation(laparoscopy/Endoscopy)
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)Systemic condition is good and tolerable for general anesthesia.
2)Cases which are expected high risk of perforation following to endoscopic mucosal resection because of local recurrence after prior endoscopic treatment or surrounding diverticles, etc.
Key exclusion criteria 1) PS(ECOG)>3
2) Cases which are expected abdominal adhesion after prior abdominal operation
3) Cases which have prior chemotherapy or radiation to the target lesion
4) Cases which have difficuty of understanding of the trial because of mental disease
5) Cases which are judged as not suitable for clinical research by a physician in attendance.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Fukunaga
Organization Cancer Institute Hospital
Division name Division of Gastroenterological Surgery and Division of Gastroenterology
Zip code
Address 3-8-31, Ariake, Kotoku, Tokyo
TEL 03-3520-0111
Email yosuke.fukunaga@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Fukunaga
Organization Cancer Institute Hospital
Division name Division of Gastroenterological Surgery
Zip code
Address 3-8-31, Ariake, Kotoku, Tokyo
TEL 03-3520-0111
Homepage URL
Email yosuke.fukunaga@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Divisiion of Gastroenterological Surgery and Division of Gastroenterology
Institute
Department

Funding Source
Organization No Source
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
2015 Year 05 Month 12 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
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 Preinitiation
Date of protocol fixation
2015 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020285

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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