UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012868
Receipt number R000015034
Scientific Title Usefulfulness and safety of Endoscopic internal abcess drainage(EIAD) for appendiceal abcess
Date of disclosure of the study information 2014/01/16
Last modified on 2017/01/18 18:24:49

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Basic information

Public title

Usefulfulness and safety of Endoscopic internal abcess drainage(EIAD) for appendiceal abcess

Acronym

Endoscopic internal abcess drainage(EIAD) for appendiceal abcess

Scientific Title

Usefulfulness and safety of Endoscopic internal abcess drainage(EIAD) for appendiceal abcess

Scientific Title:Acronym

Endoscopic internal abcess drainage(EIAD) for appendiceal abcess

Region

Japan


Condition

Condition

appendiceal abcess

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

for consider about the usefulness and safety of Endoscopic intraluminal abcess drainage for appendiceal abcess

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

compared to the length of hospital stay of past cases in Retrospective

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

We insert a drainage tube into the appendix orifice endoscopically

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

all of the appendiceal abcess

Key exclusion criteria

(1)Patients over the age of 75
(2)Patients using immunosuppressive drugs and steroids
(3)Diabetes
(4)Bleeding tendency (coagulation abnormalities)
(5)Patient physician-deemed inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehito Otsubo

Organization

St. Marianna University School of Medicine

Division name

Division of Gastroenterological and General Surgery

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Email

otsubo@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinjiro Kobayashi

Organization

St. Marianna University School of Medicine

Division name

Division of Gastroenterological and General Surgery

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Homepage URL


Email

koharubiyori@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

no

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


Address


Tel


Email



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

2014 Year 01 Month 16 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

Open public recruiting

Date of protocol fixation

2013 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 16 Day

Last modified on

2017 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015034


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name