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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032357
Receipt No. R000030267
Scientific Title Prospective randomized trial of efficacy of Delayed primary closure with the intra wound continuous negative pressure and irrigation treatment (IW-CONPIT) for dirty abdominal wound after colorectal perforation.
Date of disclosure of the study information 2018/05/01
Last modified on 2019/04/22

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Basic information
Public title Prospective randomized trial of efficacy of Delayed primary closure with the intra wound continuous negative pressure and irrigation treatment (IW-CONPIT) for dirty abdominal wound after colorectal perforation.
Acronym Prospective randomized trial of efficacy of Delayed primary closure with the intra wound continuous negative pressure and irrigation treatment (IW-CONPIT) for dirty abdominal wound after colorectal perforation.
Scientific Title Prospective randomized trial of efficacy of Delayed primary closure with the intra wound continuous negative pressure and irrigation treatment (IW-CONPIT) for dirty abdominal wound after colorectal perforation.
Scientific Title:Acronym Prospective randomized trial of efficacy of Delayed primary closure with the intra wound continuous negative pressure and irrigation treatment (IW-CONPIT) for dirty abdominal wound after colorectal perforation.
Region
Japan

Condition
Condition colorectal perforation
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of delayed primary closure with IW-CONPIT for surgical site infection prevention after colorectal perforation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of superficial and deep surgical site infection within 30 days from wound suturing.
Key secondary outcomes The rate of organ/space SSI, the rate of morbidity, the hospital stay, cost and the adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Delayed primary closure with IW-CONPIT
Interventions/Control_2 Primary closure
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
100 years-old >
Gender Male and Female
Key inclusion criteria The patients that be performed surgical operation for colorectal perforation in Saiseikai Kumamoto Hospital
Key exclusion criteria re-operation, trauma, appendicitis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Katsuhiro
Middle name
Last name Ogawa
Organization Saiseikai Kumamoto Hospital
Division name Division of surgery
Zip code 8614101
Address 5-3-1 Chikami, Minami-ku, Kumamoto-shi, Kumamoto-ken, Japan
TEL 096-351-8000
Email katsuhiro-ogawa@saiseikaikumamoto.jp

Public contact
Name of contact person
1st name Katsuhiro
Middle name
Last name Ogawa
Organization Saiseikai Kumamoto Hospital
Division name Division of surgery
Zip code 8614101
Address 5-3-1 Chikami, Minami-ku, Kumamoto-shi, Kumamoto-ken, Japan
TEL 096-351-8000
Homepage URL
Email katsuhiro-ogawa@saiseikaikumamoto.jp

Sponsor
Institute Saiseikai Kumamoto Hospital, Division of surgery
Institute
Department

Funding Source
Organization Japanese Society for Abdominal Emergency Medicine
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 Saiseikaikumamoto hospital
Address 5-3-1, Chikami, minamiku, kumamoto-shi, Kumamoto, Japan.
Tel 0963518000
Email katsuhiro-ogawa@saiseikaikumamoto.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
2018 Year 05 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 24 Day
Date of IRB
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 24 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030267

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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