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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003073
Receipt No. R000003728
Scientific Title A randomized controlled trial about clinical effect of closed subcutaneous suction drainage and subcuticular suture against surgical site infection in gastroenterological surgery
Date of disclosure of the study information 2010/01/25
Last modified on 2013/07/21

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Basic information
Public title A randomized controlled trial about clinical effect of closed subcutaneous suction drainage and subcuticular suture against surgical site infection in gastroenterological surgery
Acronym A RCT about clinical effect of subcutaneous drainage and subcuticular suture against surgical site infection
Scientific Title A randomized controlled trial about clinical effect of closed subcutaneous suction drainage and subcuticular suture against surgical site infection in gastroenterological surgery
Scientific Title:Acronym A RCT about clinical effect of subcutaneous drainage and subcuticular suture against surgical site infection
Region
Japan

Condition
Condition Gastric cancer, Colorectal cancer, Liver cancer, Biliary tract cancer, inflammatory bowel disease
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effect of closed subcutaneous suction drainage and subcuticular suture on reducing incisional surgical site infection compared to staple skin closure and subcutaneous suture in gastroenterological surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Rate of incisional surgical site infection occurrence
Key secondary outcomes Hospital stay after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Control group (interrupted subcutaneous suture and stapling skin closure)
Interventions/Control_2 Trial group (Closed subcutaneous suction drainage and interrupted subcuticular suture)
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. Elective abdominal gastroenterological surgery with resection of digestive tract .
2. ASA score 1-3
3. Written informed consent
Key exclusion criteria 1. Identical wound as previous abdominal surgery
2. Emergency operation
3. Laparoscopic surgery
4. Uncontrolled diabetes mellitus
5. Patients received colostomy
6. Patients who has abdominal drains through their operative wound
7. Patients who has abdominal enterocutaneous fistula
8. Patients who are judged inappropriate for this clinical trial by doctors
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Miyagawa
Organization Shinshu University
Division name Department of Surgery
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL 0263-37-2654
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kobayashi
Organization Shinshu University
Division name Department of Surgery
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL 0263-37-2654
Homepage URL
Email kbys@shinshu-u.ac.jp

Sponsor
Institute Shinshu University, Department of Surgery
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
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 信州大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 25 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 Completed
Date of protocol fixation
2010 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2013 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 21 Day
Last modified on
2013 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003728

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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