UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Performance of laparoscopic radical hysterectomy for cervical cancer stage IA2, IB1, IIA1
Title of the study (Brief title)	LRHStM
Region	Japan

Condition
Condition	Cervical cancer stage IA2, IB1, IIA1
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of laparoscopic radical hysterectomy for cervical cancer stage IA2, IB1, IIA1
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Operative time, Estimated blood loss, Hospital stay, Recover to normal life, Complication
Key secondary outcomes	Histological finding, Pain score, QOL score

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Laparoscopic radical hysterectcomy
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	70 years-old >
Gender	Female
Key inclusion criteria	Low risk of recurrence Good general status Informed consent to attend the study
Key exclusion criteria	Hige and young age Specimen can not retrieved outside Positive lymph node metastasis and extracervical invasion Double cancer
Target sample size	3

Research contact person
Name of lead principal investigator	Nao Suzuki
Organization	St. Marianna School of Medicine
Division name	Obstetrics and Gynecology
Address	2-16-1, Sugeo, Miyamae-Ku, Kawasaki city, Kanagawa prefecture
TEL	0449778111
Email	nao@marianna-u.ac.jp

Public contact
Name of contact person	Imari Deura
Organization	St. Marianna School of Medicine
Division name	Obstetrics and Gynecology
Address	2-16-1, Sugeo, Miyamae-Ku, Kawasaki city, Kanagawa prefecture
TEL	0449778111
Homepage URL
Email	imari@marianna-u.ac.jp

Sponsor
Institute	Obstetrics and Gynecology, St. Marianna School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 20 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded	2018 Year 07 Month 31 Day

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

Management information
Registered date	2017 Year 08 Month 15 Day
Last modified on	2018 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032818