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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010314
Receipt No. 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

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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
Email

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
Email kcrcinfo@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Department of Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011989

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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