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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040417
Receipt No. R000046109
Scientific Title The safety of postoperative care without nasogastric tube after pylorus-resectiong pancreaticoduodenectomy
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/15

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Basic information
Public title The safety of postoperative care without nasogastric tube after pylorus-resecting pancreaticoduodenectomy
Acronym The safety of no NGT after PrPD
Scientific Title The safety of postoperative care without nasogastric tube after pylorus-resectiong pancreaticoduodenectomy
Scientific Title:Acronym The safety of no NGT after PrPD
Region
Japan

Condition
Condition periampullary tumor or inflammatory disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to invastigate the safety of postoperative care without no nasogastric tube after pancreaticoduodenectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of reinsertion of nasogastric tube
Key secondary outcomes Risk factors of reinsertion of nasogastric tube
Risk factors of delayed gastric emptying

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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent pancreaticoduodenectomy from April 2009 to December 2019 at Wakayama Medical University
Key exclusion criteria 1) Patients who refused to be enrolled in this trial
2) Patients who are judged inappropriate by investigators
Target sample size 607

Research contact person
Name of lead principal investigator
1st name Motoki
Middle name
Last name Miyazawa
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture, Japan
TEL 073-441-0613
Email mo-0702@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Motoki
Middle name
Last name Miyazawa
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture, Japan
TEL 073-441-0613
Homepage URL
Email mo-0702@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 06 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 607
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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 20 Day
Date of IRB
2020 Year 05 Month 16 Day
Anticipated trial start date
2020 Year 05 Month 16 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective study of analyzing the association between patients characteristics , operative data and the reinsertion of nasogastric tube after pancretaticoduodenectomy

Management information
Registered date
2020 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046109

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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