UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011339 |
|---|---|
| Receipt number | R000013285 |
| Scientific Title | Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2018/08/07 19:06:50 |
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Basic information
Public title
Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
Acronym
Clinical study of laparoscopic rectal resection / amputation for rectal tumor using robot assisted surgery
Scientific Title
Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
Scientific Title:Acronym
Clinical study of laparoscopic rectal resection / amputation for rectal tumor using robot assisted surgery
Region
| Japan |
Condition
Condition
Rectal tumor
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical study of the safety for laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
1.Conversion to laparotomy
2.Conversion to conventional laparoscopy
Key secondary outcomes
1.Intra-operative complication
2.Post-operative complication
3.Pathological positive rate of circumferential resection margin
4.Urinary dysfunction
5.Sexual dysfunction
6.3 years rate of local 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Over 20 years old patient at the time of informed consent.
2.Rectal Tumor, histologically.
3.Performance Status (ECOG) is 0-1.
4.Patients who obtained the document voluntary consent of the patient himself after receiving a sufficient explanation upon participation in this study , on a full understanding.
Key exclusion criteria
1.Patients with pelvic surgery history by laparotomy.
2.Other organs invasive rectal cancer patients.
3.Lateral lymph node metastasis.
4.Patients with a history colon, rectal cancer, excluding mucosal cancer.
5.Patient with investigator has determined to be inappropriate as a subject.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery I
Zip code
Address
N14W5 Kita-Ku Sapporo
TEL
011-706-5927
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Homma |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery I
Zip code
Address
N14W5 Kita-Ku Sapporo
TEL
011-706-5927
Homepage URL
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
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
北海道大学病院(Hokkaido University Hospital)
Other administrative information
Date of disclosure of the study information
| 2013 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
1.Conversion to laparotomy
2.Conversion to conventional laparoscopy
3.Intra-operative complication
4.Post-operative complication
5.Pathological positive rate of circumferential resection margin
6.Urinary dysfunction
7.Sexual dysfunction
8.3 years rate of local recurrence
Management information
Registered date
| 2013 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013285
