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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001545
Receipt No. R000001863
Scientific Title Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Hepatic Resection and Pancreatoduodenectomy
Date of disclosure of the study information 2009/01/01
Last modified on 2009/10/28

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Basic information
Public title Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Hepatic Resection and Pancreatoduodenectomy
Acronym RCT about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection
Scientific Title Multicenter Prospective Randomized Trial about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection in Hepatic Resection and Pancreatoduodenectomy
Scientific Title:Acronym RCT about Clinical Effect of Absorbable Suture Materials against Surgical Site Infection
Region
Japan

Condition
Condition Liver disease, Pancreas disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) Compare rate of surgical site infection occurrence between use of absorbable sutures and silk sutures in peritoneal cavity in digestive surgery.
2) In cases with surgical site infection, compare duration of surgical site infection and hospital stay between use of absorbable sutures and silk sutures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Rate of surgical site infection occurrence
Key secondary outcomes 1) Rate of surgical site infection occurrence by sites (superficial incision wound, deep incision wound, organ/cavity)
2) 1. Duration until healing of surgical site infection
2. Occurrence rate in pancreas leakage or bile leakage
3. Hospital stay after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use of silk sutures in peritoneal cavity
Interventions/Control_2 Use of absorbable sutures in peritoneal cavity
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) Group 1: Hepatic resection
Group 2: Pancreastoduodenectomy
2) Age ranged from 20 to 80 years old
3) Child-Pugh A or B in cirrhotic patients
4) Performance status 0-1
5) Preserved general condition;
1. WBC:3,000<=WBC<10,000 /microlitre
2. Neu:Neu>=1,500 /microlitre
3. Hb:Hb>=9.0 g/dL
4. Plt:Plt>=70,000 /microlitre
5. TB:TB<=1.5 mg/dL
6. AST:AST<=100 IU/L
7. ALT:ALT<=100 IU/L
8. Cr:Cr<=1.2 mg/dL
9. Alb:Alb>=2.8 g/dL
6) Provision of written informed consent
Key exclusion criteria 1) Emergency cases
2) Group 1: Biliary reconstruction in hepatic resection
Group 2: Concomitant hepatic resection in pancreatoduodenectomy
3) Active infection
4) Pregnancy
5) ASA physical status 3<
6) Preoperative chemotherapy, radiotherapy, use of antibiotics within 2 weeks, use of immunosuppressive agent
7) Uncontrolled diabetes mellitus
8) Severe organ failure
9) Present stoma
10) Not eligible judged by doctor
Target sample size 610

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Surgery and Science
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
TEL 092-642-5466
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Kakeji
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Surgery and Science
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
TEL 092-642-5466
Homepage URL
Email kakeji@surg2.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Science,
Graduate School of Medical Sciences,
Kyushu University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 01 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 Open public recruiting
Date of protocol fixation
2008 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 02 Day
Last modified on
2009 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001863

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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