UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Title of the study (Brief title)	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	Masahiko Watanabe
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
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	Masanori Naito
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 24 Day
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

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Publication of results	Unpublished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