UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013919 |
|---|---|
| Receipt number | 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 19:50:26 |
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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
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
hidakoya@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japan Society of Laparoscopic Colorectal Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
