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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036322
Receipt No. 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

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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
Email 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
Email i_eisaku_ukasie@yahoo.co.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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