UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of laparoscopic radical hysterectomy for patients with early-stage uterine cervical cancer
Title of the study (Brief title)	Efficacy and safety of laparoscopic radical hysterectomy for patients with early-stage uterine cervical cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of laparoscopic radical hysterectomy for cervical cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological evaluation of surgical completion
Key secondary outcomes	Surgical adverse effect(blood loss, blood transfusion, postoperative complications)

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 radical hysterectomy
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	1)International Federation of Gynec ology and Obstetrics (FIGO) stage of IA 2, IB1, or IIA1 2)Age of over 20 years 3)Those with adequate organ function 4)Those who have given written informed consent
Key exclusion criteria	1)Tumor diameter>40mm 2)Those with serious complication 3)Those with concomitant active malignancy 4)Those who are inadequate to be enrolled in the protocol study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Hideto Katayama
Organization	Asahikawa Medical University
Division name	Department of Obstetrics and Gynecology
Address	Midorigaoka Higashi 2-1-1-1,Asahikawa,Japan
TEL	0166-65-2111
Email	kyama@asahikawa-med.ac.jp

Public contact
Name of contact person	Hideto Katayama
Organization	Asahikawa Medical University
Division name	Department of Obstetrics and Gynecology
Address	Midorigaoka Higashi 2-1-1-1,Asahikawa,Japan
TEL	0166-65-2111
Homepage URL
Email	kyama@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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 05 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 10 Day
Anticipated trial start date	2017 Year 05 Month 02 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 05 Month 02 Day
Last modified on	2017 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031200