UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035755
Receipt No. R000040672
Official scientific title of the study The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Date of disclosure of the study information 2019/02/06
Last modified on 2019/02/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Title of the study (Brief title) The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Region
Japan

Condition
Condition colorectal carcinoma
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the adhesion preventing effect by wrapping sodium hyaluronate / carboxymethyl cellulose adhesion preventing absorbable barrier (Seprafilm) on ileostomy at the time of constructing temporary ileostomy in laparoscopic colon resection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of adhesion around ileostomy
Key secondary outcomes The extent and extent of adhesion around the ileostomy
operative time during ileostomy closure
Bleeding volume
hospital stay after ileostomy closure
Adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Wrap a seprafilm around the ileum when constructing temporary ileostomy.
Interventions/Control_2
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 1) Laparoscopic colon resection or rectal resection with robot assistance involving temporary ileostomy is planned
2) Age is over 20 years old
3) ECOG's Performance Status (PS) is 0 - 1
4) Document consent has been obtained
Key exclusion criteria Case in which infection is observed at the site to which the Seprafilm is to be applied
Patients with a history of hypersensitivity to components of Seprafilm.
Cases with severe liver disease.
Cases with severe kidney disease.
Pregnant women, possible cases of pregnancy.
Other cases that the physician judged as maladaptive.
Target sample size 20

Research contact person
Name of lead principal investigator Ichiro Takemasa
Organization Sapporo medical university hospital
Division name Department of Surgery,Surgical Oncology and Science
Address nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL 011-611-2111
Email okuya@sapmed.ac.jp

Public contact
Name of contact person Koichi Okuya
Organization Sapporo medical university
Division name Department of Surgery,Surgical Oncology and Science
Address nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL 011-611-2111
Homepage URL
Email okuya@sapmed.ac.jp

Sponsor
Institute Sapporo medical university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 06 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 08 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 03 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040672

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.