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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033529
Receipt No. R000038231
Scientific Title Retrospective study to evaluate oncologic safety of laparoscopic surgery for obese colorectal cancer patients
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/26

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Basic information
Public title Retrospective study to evaluate oncologic safety of laparoscopic surgery for obese colorectal cancer patients
Acronym Retrospective study to evaluate oncologic safety of laparoscopic surgery for obese colorectal cancer patients (LOVERY Study)
Scientific Title Retrospective study to evaluate oncologic safety of laparoscopic surgery for obese colorectal cancer patients
Scientific Title:Acronym Retrospective study to evaluate oncologic safety of laparoscopic surgery for obese colorectal cancer patients (LOVERY Study)
Region
Japan

Condition
Condition Obese colorectal cancer patients who underwent open or laparoscopic surgery (BMI is 25 and more).
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate oncologic safety of laparoscopic surgery for obese colorectal cancer patients.
To verify noninferiority of laparoscopic surgery to laparotomy for obese colorectal cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The 3-year relapse-free survival rate
Key secondary outcomes The 3-year overall survival, The amount of estimated blood loss, The duration of operation, The degree of lymph node dissection, The number of lymph nodes evaluated, The number of positive lymph nodes, Postoperative complication, Mortality within 30 days of surgery, Postoperative length of stay, and Site of recurrence.

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 Location: Primary resection of colorectal cancer located in cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid colon, Ra, and Rb
Surgery: Performed from Jan. 2009 to Dec. 2013
Approach: Laparotomy or laparoscopically
BMI: 25 and more
Pathological stage: Stage 2 and 3
ASA: 1 or 2
Curability: A
Key exclusion criteria Double cancer
Multiple cancer
Curability: B or C
Location: Appendix or anal canal
ASA:3 to 6
Target sample size 4800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Nakajima
Organization NTT Medical Center Tokyo
Division name Department of Surgery
Zip code
Address 5-9-22, Higashi-Gotanda, Shinagawa-Ku, Tokyo, 141-8625, Japan
TEL 81(3)3448-6111
Email knsurzx@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Nakajima
Organization Oita University Faculty of Medicine
Division name Department of Gastroenterological and Pediatric Surgery
Zip code
Address 1-1 Idaigaoka, Yufu, Oita 879-5593 , Japan
TEL 81(97)586-5843
Homepage URL
Email lovery@oita-u.ac.jp

Sponsor
Institute Japan Society of Laparoscopic Colorectal Surgery
Institute
Department

Funding Source
Organization Japan Society of Laparoscopic Colorectal Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2018 Year 08 Month 01 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
2018 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2019 Year 07 Month 01 Day

Other
Other related information None

Management information
Registered date
2018 Year 07 Month 26 Day
Last modified on
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038231

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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