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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038280
Receipt No. R000043636
Scientific Title Study for the safety and feasibility of gastroenterological surgery in patients undergoing antithrombotic therapy: A multicenter prospective cohort analysis
Date of disclosure of the study information 2019/10/12
Last modified on 2020/10/12

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Basic information
Public title Study for the safety and feasibility of gastroenterological surgery in patients undergoing antithrombotic therapy
Acronym GSATT study
Scientific Title Study for the safety and feasibility of gastroenterological surgery in patients undergoing antithrombotic therapy: A multicenter prospective cohort analysis
Scientific Title:Acronym GSATT study
Region
Japan

Condition
Condition Digestive diseases requiring gastroenterological surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The main purpose of this multicenter prospective cohort study is to assess the safety and feasibility of GE surgery in ATT-received patients during the perioperative period.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Intraoperative factors including surgical blood loss, duration of operation and intraoperative red blood cell transfusion, (2) postoperative hemorrhagic complications, (3) postoperative thromboembolic complications.
Key secondary outcomes (1) Other postoperative complications,
(2) Presence of postoperative re-operation, and (3) The length of postoperative day.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participants are included if all following criteria are met: (1) Patients receiving antithrombotic therapy (antiplatelet therapy and/or anticoagulation therapy), (2) Those undergoing elective GE surgery (including open surgery, laparoscopic surgery, and robot-assisted surgery), and (3) Those being able to submit written consent before the study.
Key exclusion criteria Exclusion criteria were as follows: (1) urgent surgery, (2) being difficult to obtain consent for explanations, such as consciousness levels and examples of cognitive decline, and (3) written consent being not obtained. The number of such patients is reported separately.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Takahisa
Middle name
Last name Fujikawa
Organization Kokura Memorial Hospital
Division name Surgery
Zip code 8028555
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
TEL 0935112000
Email fujikawa-t@kokurakinen.or.jp

Public contact
Name of contact person
1st name Shigetoshi
Middle name
Last name Naito
Organization Kokura Memorial Hospital
Division name Surgery
Zip code 8028555
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
TEL 0935112000
Homepage URL
Email shinaito@fukuoka-u.ac.jp

Sponsor
Institute Department of Surgery, Kokura Memorial Hospital
Institute
Department

Funding Source
Organization Department of Surgery, Kokura Memorial Hospital
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 Kokura Memorial Hospital
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
Tel 0935112000
Email shinaito@fukuoka-u.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
2019 Year 10 Month 12 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 Enrolling by invitation
Date of protocol fixation
2019 Year 08 Month 28 Day
Date of IRB
2019 Year 10 Month 20 Day
Anticipated trial start date
2019 Year 10 Month 20 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information URL releasing protocol(not yet published but scheduled):
http://www.ghrnet.org/index.php/joghr

Management information
Registered date
2019 Year 10 Month 12 Day
Last modified on
2020 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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