UMIN-CTR Clinical Trial

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

Abdominal laparoscopic surgery for colon and rectum

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Johnson&Johnson K.K. Medical Company

Institute

Department

Personal name

Organization

Johnson&Johnson K.K. Medical Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

08

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Prospective, consecutive, multicenter, single-arm observational study

Registered date

2015

Year

08

Month

19

Day

Last modified on

2017

Year

06

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021635