UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040315
Receipt number R000045997
Scientific Title A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy.
Date of disclosure of the study information 2020/05/06
Last modified on 2024/05/10 16:47:32

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Basic information

Public title

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy.

Acronym

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy.

Scientific Title

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy.

Scientific Title:Acronym

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy.

Region

Japan


Condition

Condition

Acute abdomen during cancer chemotherapy.

Classification by specialty

Hematology and clinical oncology Surgery in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to clarify the clinical outcomes of emergency surgery for acute abdomen during chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Surgical mortaliry

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

All surgery cases for acute abdomen during chemotherapy

Key exclusion criteria

None

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name Maeda

Organization

Hokkaido Cancer Center

Division name

Department of Gastrointestinal Surgery

Zip code

003-0804

Address

4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN

TEL

0118119111

Email

maeda19671101@yahoo.co.jp


Public contact

Name of contact person

1st name Yoshiaki
Middle name
Last name Maeda

Organization

Hokkaido Cancer Center

Division name

Department of Gastrointestinal Surgery

Zip code

003-0804

Address

4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN

TEL

0118119111

Homepage URL


Email

maeda19671101@yahoo.co.jp


Sponsor or person

Institute

Hokkaido Cancer Center.

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Cancer Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JP


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido Cancer Center

Address

4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN

Tel

0118119111

Email

maeda.yoshiaki.cx@mail.hosp.go.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 05 Month 06 Day


Related information

URL releasing protocol

published. Oncological outcomes of repeat metastasectomy for recurrence after hepatectomy for color

Publication of results

Partially published


Result

URL related to results and publications

A retrospective analysis of emergency surgery for cases of acute abdomen during cancer chemotherapy.

Number of participants that the trial has enrolled

30

Results

Results: Twenty-four patients includes 9 female and 15 male, and mean age was 60.2 years old (24-84). Primary sites of malignancy were 5 lung cancer, 5 malignant lymphoma, 3 colorectal cancer, 2 multiple myeloma, 2 uterine cancer, and 7 other origins. Fifteen patients received multi-drug regimens consisted of 3 or more anti-cancer drugs, and 12 patients were treated by the regimen with molecular-targeted anti-cancer drugs.


Results date posted

2024 Year 05 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 07 Month 31 Day

Baseline Characteristics

Published

Participant flow

Published

Adverse events

NA

Outcome measures

published

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2018 Year 12 Month 12 Day

Anticipated trial start date

2019 Year 01 Month 01 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

None


Management information

Registered date

2020 Year 05 Month 06 Day

Last modified on

2024 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045997