UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033529 |
|---|---|
| Receipt number | 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 | 2022/07/30 18:11:56 |
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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 | Kentaro |
| Middle name | |
| Last name | Nakajima |
Organization
NTT Medical Center Tokyo
Division name
Department of Surgery
Zip code
1410022
Address
5-9-22, Higashi-Gotanda, Shinagawa-Ku, Tokyo, 141-8625, Japan
TEL
81(3)3448-6111
knsurzx@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakajima |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological and Pediatric Surgery
Zip code
8795503
Address
1-1 Idaigaoka, Yufu, Oita 879-5593 , Japan
TEL
81(97)586-5843
Homepage URL
lovery@oita-u.ac.jp
Sponsor or person
Institute
Japan Society of Laparoscopic Colorectal Surgery
Institute
Department
Personal name
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
NTT Medical Center Tokyo
Address
Shinagawa-ku, Higashigotanda, 5-9-22
Tel
09047169658
knsurzx@gmail.com
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
| 2022 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038231
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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