UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Acronym	A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Scientific Title	A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Scientific Title:Acronym	A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Region	Japan

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

Objectives
Narrative objectives1	To assess the safety and efficacy of The Reinforced Stapler on laparoscopic rectal cancer surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of anastomotic leakage.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients undergoing laparoscopic rectal cancer resection and anastomosis (regardless of cancer stage); 2)Patients with an ECOG PS of 0 or 1; 3)Patients aged at least 20 years; 4)Patients who have given written consent to participate in the study; and 5)Patients with the distal margin of rectal cancer at 15 cm or less from the anal verge.
Key exclusion criteria	1)Patients with serious ischemic heart disease; 2)Patients with cirrhosis or active hepatitis; 3)Patients with dyspnea requiring oxygen administration; 4)Patients under dialysis due to chronic renal failure; 5)Patients requiring combined resection of any other organ; or 6)Patients ineligible for the study for any other reason, as judged by the investigator.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Takemasa
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Email	itakemasa@sapmed.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Nishidate
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Homepage URL
Email	nisidate@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
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)

IRB Contact (For public release)
Organization	Sapporo Medical University
Address	Minami1-Nishi16, cyuo-ku, Sapporo, Hokkaido
Tel	011-611-2111
Email	rskk@sapmed.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	2017 Year 10 Month 15 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	307
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	In the analysis
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	No longer recruiting
Date of protocol fixation	2017 Year 08 Month 20 Day
Date of IRB	2017 Year 10 Month 17 Day
Anticipated trial start date	2017 Year 10 Month 17 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 12 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	To assess the safety and efficacy of The Reinforced Stapler in rectum resection on laparoscopic rectum cancer surgery.

Management information
Registered date	2017 Year 10 Month 13 Day
Last modified on	2021 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033729