UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040969
Receipt No. R000046784
Scientific Title A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Date of disclosure of the study information 2020/09/01
Last modified on 2020/07/01

* 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
Public title A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Acronym Balsam SEED study
Scientific Title A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Scientific Title:Acronym Balsam SEED study
Region
Japan

Condition
Condition postoperative bowel obstruction
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarifying the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Cases histologically proven as colorectal cancer
2) Cases without metastatic lesions and/or invasion to the adjacent organs
3) Cases performed laparoscopic surgery
4) Cases performed curative surgery
5) Cases using INTERCEED as an adhesion barrier material
6) Patients between the ages of 20 and 80
7) Patients with ECOG Performance states 0-1
8) Cases enrolled within 3 days of surgery
9) Patients with all of the following on examination within 1 month prior to enrollment, with preserved major organ function and no suspected active infection
-White blood cell count: 3,000/mm3 or higher
-Platelet count: 75,000/mm3 or higher
-Hemoglobin: 8.0 g/dl or higher
-Serum AST and ALT: 2.5 times or less than the upper limit of the institutional reference value
-Serum total bilirubin: less than 1.5 mg/dl
-Serum creatinine: 1.5 mg/dl or less
Key exclusion criteria 1) Patients for whom Interseed is contraindicated
2) Patients who received previous abdominal surgery (except for appendectomy performed more than 5 years ago). Anterior approach to inguinal hernia surgery is acceptable.
3) Patients deemed ineligible to participate in this study bytheir physicians
4) Patients with cancer recurrence within 2 years will be excluded at the time of statistical analysis.
5) Cases cannot followed for 2 years will be excluded a the time of statistical analysis.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Yamada
Organization Nippon medical school
Division name Department of Gastrointestinal and Hepatp-Biliary-Pancreatic Surgery
Zip code 113-8603
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 0338222131
Email y-tak@nms.ac.jp

Public contact
Name of contact person
1st name Hiromichi
Middle name
Last name Sonoda
Organization Nippon medical school
Division name Department of Gastrointestinal and Hepatp-Biliary-Pancreatic Surgery
Zip code 113-8603
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 0338222131
Homepage URL
Email hiromichi-sonoda@nms.ac.jp

Sponsor
Institute Nippon medical school
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee at Nippon medical school
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel 0338222131
Email nms_fuzokurinri@nms.ac.jp

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
2020 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2024 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will follow up on the occurrence of bowel obstruction up to two years after laparoscopic colorectal cancer surgery by physical examination and abdominal computed tomography.

Management information
Registered date
2020 Year 07 Month 01 Day
Last modified on
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.