UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036322 |
|---|---|
| Receipt number | R000041382 |
| Scientific Title | Case series of in situ pelvic floor reconstruction combining levator ani suture and negative pressure wound therapy for laparoscopic abdominoperineal resection |
| Date of disclosure of the study information | 2019/03/27 |
| Last modified on | 2019/10/13 01:30:05 |
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Basic information
Public title
Case series of in situ pelvic floor reconstruction combining levator ani suture and negative pressure wound therapy for laparoscopic abdominoperineal resection
Acronym
Case series of in situ pelvic floor reconstruction combining levator ani suture and negative pressure wound therapy for laparoscopic abdominoperineal resection
Scientific Title
Case series of in situ pelvic floor reconstruction combining levator ani suture and negative pressure wound therapy for laparoscopic abdominoperineal resection
Scientific Title:Acronym
Case series of in situ pelvic floor reconstruction combining levator ani suture and negative pressure wound therapy for laparoscopic abdominoperineal resection
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the efficacy of the in situ pelvic floor reconstruction combining levator ani suture and NPWT after laparoscopic APR for perineal hernia and perineal surgical site infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
surgical site infection, perineal hernia
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
rectal cancer
Key exclusion criteria
None
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Ito |
Organization
International University of Health and Welfare
Division name
Surgery
Zip code
329-2763
Address
537-3, Iguchi, Nasu-shiobara-shi, Tochigi
TEL
0287-37-2221
i_eisaku_ukasie@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Eisaku |
| Middle name | |
| Last name | Ito |
Organization
International University of Health and Welfare
Division name
Surgery
Zip code
329-2763
Address
537-3, Iguchi, Nasu-shiobara-shi, Tochigi
TEL
0287-37-2221
Homepage URL
i_eisaku_ukasie@yahoo.co.jp
Sponsor or person
Institute
International University of Health and Welfare
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
International University of Health and Welfare
Address
537-3, Iguchi, Nasu-shiobara-shi, Tochigi
Tel
0287-37-2221
i_eisaku_ukasie@yahoo.co.jp
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
| 2019 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2049080119300494?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2049080119300494?via%3Dihub
Number of participants that the trial has enrolled
6
Results
There was no patient with surgical site infection within 30 days or with perineal hernia
within 1 year after surgery.
Results date posted
| 2019 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 31 | Day |
Baseline Characteristics
Rectal cancer
Participant flow
APR
Adverse events
None
Outcome measures
surgical site infection within 30 days and with perineal hernia within 1 year after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The in situ pelvic floor reconstruction combining levator ani suture and NPWT after
laparoscopic APR was safe
and may be effective for preventing surgical site infection and perineal hernia.
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041382
| 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 |
