UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive surgery to improve postoperative lymphedema in lower limb after total hysterectomy by lymphatic venous anastomosis procedure utilizing da Vinci Surgical System (Phase I study)
Title of the study (Brief title)	Lymphatic venous anastomosis assisted by da Vinci Surgical System (Phase I Study)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of robot-assisted lymphatic venous anastomosis procedure in lower limb lymphedema developed after total hysterectomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Intra and postoperative complication, prognosis
Key secondary outcomes	5 year survival, post-operative incidence of lower limb lymphedema

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Lymphatic venous anastomosis utilizing da Vinci Surgical System
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	Not applicable
Gender	Female
Key inclusion criteria	Endometrial cancer, requiring pelvic and/or paraaortic lymphadenectomy.
Key exclusion criteria	Cases in which robot-assisted surgery or lymphatic venous anastomosis is technically unfeasible or unnecessary, due to complications or other reasons.
Target sample size	3

Research contact person
Name of lead principal investigator	Hiroshi Sasaki
Organization	CHIBA TOKUSHUKAI HOSPITAL
Division name	Gynecology
Address	2-11-1 Takanedai, Funabashi-shi, Chiba Japan
TEL	047-466-7111
Email	hrssasaki0226@gmail.com

Public contact
Name of contact person	Hiroshi Sasaki
Organization	CHIBA TOKUSHUKAI HOSPITAL
Division name	Gynecology
Address	2-11-1 Takanedai, Funabashi-shi, Chiba Japan
TEL	047-466-7111
Homepage URL
Email	hrssasaki0226@gmail.com

Sponsor
Institute	CHIBA TOKUSHUKAI HOSPITAL
Institute
Department

Funding Source
Organization	CHIBA TOKUSHUKAI HOSPITAL
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 12 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 27 Day
Last modified on	2018 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033724