UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
Title of the study (Brief title)	A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of Endo GIA Tri-Staple in laparoscopic left colectomy and rectal resection with DST anastomosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of staples used and the condition on rectal stump
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Endo GIA Tri-Staple
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) 20 years old or older (no upper limit) 2) Patients scheduled for DST anastomosis after laparoscopic left colectomy or rectal resection. 3) No history of abdominal surgery(except appendectomy) 4) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1 5) Healthy organ function 6) Written informed consent is obtained from the patient him/herself
Key exclusion criteria	1) laparoscopic surgery under reduced port surgery 2) Patients having pregnant, nursing or probability of pregnancy 3) Patients receiving continued systemic (oral or intravenous) steroids 4) tients with uncontrolled diabetes mellitus (HbA1c >8.0%) 5) Patients having allergic reaction to nickel-chromium alloy 6) Judged difficulty due to study complications related to a psychiatric disorder or psychological symptoms 7) Judged unsuitable patient for study participation by the investigator for any other reason
Target sample size	50

Research contact person
Name of lead principal investigator	Hirotoshi Hasegawa, M.D.
Organization	Keio University School of Medicine
Division name	Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo Japan
TEL
Email

Public contact
Name of contact person	Koji Okabayashi
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address
TEL	03-3353-1211
Homepage URL
Email

Sponsor
Institute	Keio University School of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization	Covidien Japan Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2012 Year 06 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 21 Day
Anticipated trial start date	2012 Year 07 Month 01 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	2012 Year 06 Month 29 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009655