UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026196
Receipt number R000030093
Scientific Title Safety and effectiveness of laparoscopic sleeve gastrectomy
Date of disclosure of the study information 2017/04/01
Last modified on 2020/06/10 15:12:31

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Basic information

Public title

Safety and effectiveness of laparoscopic sleeve gastrectomy

Acronym

Safety and effectiveness of laparoscopic sleeve gastrectomy

Scientific Title

Safety and effectiveness of laparoscopic sleeve gastrectomy

Scientific Title:Acronym

Safety and effectiveness of laparoscopic sleeve gastrectomy

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the result of surgical treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Complication rate and % excess weight loss

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

Maneuver

Interventions/Control_1

Laparoscopic sleeve gastrectomy

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

1. Patients who is more than 20 years old obtaining informed consent.
2. Patients with Diabetes mellitus, hypertention, hyperlipidemia
3. Patients who do not have sufficient weight loss and improvement of complications associated with obesity with medical treatments longer than 6 months
4. Performance status 0 or 1

Key exclusion criteria

1.Psychiatric patients who is difficult to participate in this study.
2. Dependence of drugs, alcohol, tobacco
3. Patients with taking immunosuppressive drugs
4. Patients with serious heart failure

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name KODERA

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

4668550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2233

Email

ykodera@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name TANAKA
Middle name
Last name Chie

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2249

Homepage URL


Email

chtanaka@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Graduate School of Medicine

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

The Institutional Review Board of the Ethics Committee of Nagoya University School of Medicine

Address

65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

Tel

052-744-2061

Email

ethics@med.nagoya-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

2017 Year 04 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

10

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

2017 Year 04 Month 01 Day

Date of IRB

2017 Year 05 Month 10 Day

Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2023 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 17 Day

Last modified on

2020 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030093


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name