UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Masahiko Watanabe
Organization	Kitasato University
Division name	Kitasato University Department of Surgery
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kitasato University School of Medicine
Division name	Kitasato Clinical Research Center
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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