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


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 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


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

Value
https://center6.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