UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038280 |
|---|---|
| Receipt number | 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 | 2023/11/01 13:59:42 |
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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
fujikawa-t@kokurakinen.or.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kokura Memorial Hospital
Division name
Surgery
Zip code
8028555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
TEL
0935112000
Homepage URL
taicomcom@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery, Kokura Memorial Hospital
Institute
Department
Personal name
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
taicomcom@yahoo.co.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
http://www.ghrnet.org/index.php/joghr/article/view/2702/3053
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/annalsofsurgery/abstract/9900/management_of_patients_receiving_antiplatelet
Number of participants that the trial has enrolled
1170
Results
Multivariate investigation of the entire cohort revealed that discontinuation of APT and chronic anticoagulant use were independent risk factors for postoperative thromboembolism. The post-matching evaluation demonstrated that the rates of thromboembolic complications were significantly different between the continued and discontinued APT groups (0.6% vs. 3.3%; P=0.012).
Results date posted
| 2023 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This prospective multicenter cohort study on the Safety and Feasibility of Gastroenterological Surgery in Patients Undergoing Antithrombotic Therapy (GSATT study) conducted at 14 clinical centers enrolled and screened patients between October 2019 and December 2021.
Participant flow
We screened 1175 patients between October 2019 and December 2021 at 14 clinical sites in Japan. Of these patients, the primary survey included 1170 (99.6%) patients.
Adverse events
None
Outcome measures
The primary outcomes were thromboembolic and bleeding complications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043636
