UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002909 |
|---|---|
| Receipt number | 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 | 2021/05/25 15:31:39 |
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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
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
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
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
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
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 |
