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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018727
Receipt No. R000021635
Scientific Title Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Date of disclosure of the study information 2015/08/23
Last modified on 2017/06/21

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Basic information
Public title Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Acronym Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Scientific Title Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Scientific Title:Acronym Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Region
Japan

Condition
Condition Abdominal laparoscopic surgery for colon and rectum
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical performance of oxidized regenerated cellulose INTERCEED adhesive barrier in abdominal surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adhesive Intestinal Obstruction
Key secondary outcomes - Revision surgery
-- Revision surgery related to postoperative bleeding
-- Revision surgery related to anastomotic leak/ drainage
- Surgical Site Infection (SSI)
-- Superficial incisional surgical site infection
-- Deep incisional surgical site infection
-- Organ surgical site infection
- Anastomotic leak
- Other adverse events that lead to therapeutic interventions (surgery and/ or medication that differ from the standard pathway of care)
- Death

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Subjects who are 20 years or older
2. Subjects undergoing abdominal laparoscopic surgery
3. Subjects with the will of participating in the study, and provided written informed consent
4. Subjects in whom the use of INTERCEED may be considered during the planned surgery.
Key exclusion criteria 1. Subjects in whom the laparoscopic procedure needs to be converted to open surgery.
2. Patients in whom significant adhesive disease is already present at the inception of the procedure requiring adhesiolysis that impacts surgical time.
3. Subjects in whom a complete excision of the tumor could not be achieved.
4. Subjects with intraoperative intraperitoneal administration of chemotherapy.
5. Subjects with severe hepatic dysfunction, renal failure, heart disease and infectious disease.
6. Subjects in whom alternate adhesive prevention methods are used
7. Subjects in whom complete hemostasis could not be achieved at the location where INTERCEED was going to be used
8. Subjects in whom the location where INTERCEED was going to be used is considered infected
9. Subjects with history of severe drug allergy.
10. Subjects with allergy of oxidized regenerated cellulose.
11. Subjects in whom the treating physician does not feel that the application of INTERCEED is appropriate
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1,kitasato,minami-ku,sagamihara-city,Kanagawa, Japan
TEL 042-778-8111
Email gekaw@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Naito
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1,kitasato,minami-ku,sagamihara-city,Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email mnaito@kitasato-u.ac.jp

Sponsor
Institute Johnson&Johnson K.K. Medical Company
Institute
Department

Funding Source
Organization Johnson&Johnson K.K. Medical Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective, consecutive, multicenter, single-arm observational study

Management information
Registered date
2015 Year 08 Month 19 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021635

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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