UMIN-CTR Clinical Trial

Basic information
Public title	Laparoscopic radical hysterectomy
Acronym	Laparoscopic radical hysterectomy
Scientific Title	Laparoscopic radical hysterectomy
Scientific Title:Acronym	Laparoscopic radical hysterectomy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the feasibility, safety and oncological outcome of the laparoscopic radical hysterectomy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of resected specimen 3 yr disease free survival
Key secondary outcomes	Diesease free survival 3,5yr survival operation time blood loss transfuseon rate intra-postoperative complication post operative quality of life compared with the laparotomy

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	surgery Laparoscopic radical hysterectomy & pelvic lymphadenectomy
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) cervical cancer stage IA2,IB1,IIA1
Key exclusion criteria	1) huge leiomyoma or adenomayosis 2) severe comorbidity 3) performance status 3.4 4) patients judged inappropriate for this study by the physician
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Kita
Organization	Kansai Medical University
Division name	Obstetrics and Gynecology
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata Osaka 573-1010
TEL	0728040101
Email	kitamas@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Kita
Organization	Kansai Medical University
Division name	Obstetrics and Gynecology
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata Osaka 573-1010
TEL	072-804-0101
Homepage URL
Email	kitamas@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Kansai Medical 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	Kansai Medical University
Address	Shinmachi 2-5-1, HIrakata City, Osaka, Japan
Tel	072-804-0101
Email	kitamas@hirakata.kmu.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	関西医科大学

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 10 Day

Related information
URL releasing protocol	none
Publication of results	Unpublished

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	3
Results	no complications
Results date posted	2021 Year 10 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	not paricular
Participant flow	as scheduled
Adverse events	none
Outcome measures	no abnormal findings
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 19 Day
Date of IRB	2015 Year 02 Month 10 Day
Anticipated trial start date	2015 Year 02 Month 10 Day
Last follow-up date	2020 Year 02 Month 10 Day
Date of closure to data entry	2020 Year 02 Month 10 Day
Date trial data considered complete	2020 Year 02 Month 10 Day
Date analysis concluded	2020 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date	2015 Year 02 Month 10 Day
Last modified on	2022 Year 08 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019161