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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011376
Receipt No. R000013322
Scientific Title The evaluation for safety and usefulness of the laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy for low-risk uterine corpus cancer
Date of disclosure of the study information 2013/08/05
Last modified on 2017/02/06

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Basic information
Public title The evaluation for safety and usefulness of the laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy for low-risk uterine corpus cancer
Acronym The evaluation for safety and usefulness of the laparoscopic surgery for uterine corpus cancer
Scientific Title The evaluation for safety and usefulness of the laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy for low-risk uterine corpus cancer
Scientific Title:Acronym The evaluation for safety and usefulness of the laparoscopic surgery for uterine corpus cancer
Region
Japan

Condition
Condition Uterine corpus cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is the evaluation for safety of the laparoscopic surgery for uterine endometrial cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Operation time, blood loss, the number of lymph nodes, complications, postsurgical pain, hemoglobin concentration, the levels of serum CRP
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy
Interventions/Control_2 Abdominal total hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy
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
75 years-old >
Gender Female
Key inclusion criteria Low-recurrent risk uterine corpus cancer (FIGO IA and endometrioid adenocarcinoma, G1 or G2) that requires surgery
Key exclusion criteria Inappropriate cases for laparoscopic surgeries due to severe endometriosis, large uterine leiomyoma, severe obesity, severe intraabdominal adhesion and other factors
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Iwase
Organization Nagoya University Graduate School of Medicine
Division name Maternal and Perinatal Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2261
Email akiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Iwase
Organization Nagoya University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2261
Homepage URL
Email akiwase@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya 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
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
2013 Year 08 Month 05 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 No longer recruiting
Date of protocol fixation
2013 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 05 Day
Last modified on
2017 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013322

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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