UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010314 |
|---|---|
| Receipt number | R000011989 |
| Scientific Title | Prospective randomized controlled study about the adhesion prevention safety and effects for the general surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose. |
| Date of disclosure of the study information | 2013/03/25 |
| Last modified on | 2018/03/29 16:39:33 |
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Basic information
Public title
Prospective randomized controlled study about the adhesion prevention safety and effects for the general surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Acronym
Randomized controlled trials of the safety and effectiveness of the anti-adhesion for the abdominal surgery using the synthetic absorbable adhension barrier.(SAAB)
Scientific Title
Prospective randomized controlled study about the adhesion prevention safety and effects for the general surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Scientific Title:Acronym
Randomized controlled trials of the safety and effectiveness of the anti-adhesion for the abdominal surgery using the synthetic absorbable adhension barrier.(SAAB)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate the safety and effectiveness of the anti-adhesion for the Laparoscopic surgery using the synthetic adhesion barrier.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of serious adverse event within 30 days from surgery.
Key secondary outcomes
Frequency of serious adverse event within 6 months after surgery.
Frequency of infection of the surgical site within 30 days and 6 months after surgery.
Frequency of adhesive ileus within 30 days and 6 months after surgery.
The use of evaluation of the intercede during surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A piece of dried interceed which is 3-5mm larger than the surgery site will be placed to prevent adhesion just before abdominal closure of the laparoscopic surgery.
Interventions/Control_2
Normal laparoscopic surgery (without interceed)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who aged over 20 years old
Patients who adapt for the laparoscopic surgery of the lower gastrointestinal
Patients who have intention of the participation in this study and agree to sign on the written informed consent
Patients who are judged as appropriate using interceed by a doctor
Key exclusion criteria
Patients who have persistence of cancer macroscopically
Patients who are given anticancer drugs intraperitoneally
Patients who have sever hapatic damage, kidney damage, heart disease and infection desease
Patients who will be used other anti-adhesion methods in both groups including the non-use interceed
Patients who will be used over the site that has been soaked in blood
Patients who will be used over the contaminated or infected wound
Patients who have history of severe drug allergy
Patients who have history of oxidized regenerated cellulose allergy
Patients who are judged inappropriate by a doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Watanabe |
Organization
Kitasato University
Division name
Kitasato University Department of Surgery
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University School of Medicine
Division name
Kitasato Clinical Research Center
Zip code
Address
TEL
Homepage URL
kcrcinfo@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson
Organization
Division
Category of Funding Organization
Profit organization
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
北里大学病院（神奈川県）、北里大学東病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 25 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011989
