UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013678 |
|---|---|
| Receipt number | R000015970 |
| Scientific Title | The clinical study on the safety of reduced port laparoscopic surgery for colorectal disease |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2016/10/11 15:26:34 |
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Basic information
Public title
The clinical study on the safety of reduced port laparoscopic surgery for colorectal disease
Acronym
The clinical study on the safety of reduced port laparoscopic surgery for colorectal disease
Scientific Title
The clinical study on the safety of reduced port laparoscopic surgery for colorectal disease
Scientific Title:Acronym
The clinical study on the safety of reduced port laparoscopic surgery for colorectal disease
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of reduced port laparoscopic surgery dor colorectal disease using SILSTM port.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of reduced port laparoscopic surgery dor colorectal disease
Key secondary outcomes
1.Operation time
2.Estimated blood loss
3.Postoperative local morbidity rate
(Anastomotic leakage, wound infection, bowel obstruction)
4.Postoperative systemic complications incidence(Pneumonia, thromboembolism, such as urinary tract infection)
5.Postoperative length of stay
6.Postoperative pain assessment
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
1.Age of patients between 20 and 80 years old at time of acquisition consent.
2. After receiving a sufficient explanation upon participation in this study, on a thorough understanding, patients who obtained the document voluntary consent of the patient himself.
Key exclusion criteria
1.Preoperative bowel obstruction.
2.Patients who were not kept vital sign in the head low or 10mmHg pneumoperitoneum on intraoperative.
3.Investigator was deemed inappropriate as this subject.
Target sample size
30
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
N15W7 Sapporo Hokkaido Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Homma |
Organization
Hokkaido University
Division name
Gastroenterological Surgery I
Zip code
Address
N15W7 Sapporo Hokkaido Japan
TEL
011-706-5927
Homepage URL
homma.s@nifty.com
Sponsor or person
Institute
Department of Gastroenterological Surgery I Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery I Hokkaido University
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Completion rate of reduced port laparoscopic surgery dor colorectal disease
2.Operation time
3.Estimated blood loss
4.Postoperative local morbidity rate
(Anastomotic leakage, wound infection, bowel obstruction)
5.Postoperative systemic complications incidence(Pneumonia, thromboembolism, such as urinary tract infection)
6.Postoperative length of stay
7.Postoperative pain assessment
Management information
Registered date
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015970
| 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 |
