UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003073 |
|---|---|
| Receipt number | 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 20:37:55 |
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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
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
kbys@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University, Department of Surgery
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003728
