UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation for safety and effectiveness of the laparoscopic radical hysterectomy and pelvic lymphadenectomy for stage IA, IB and IIA uterine cervical cancer.
Title of the study (Brief title)	The evaluation for safety and effectiveness of the laparoscopic surgery for uterine cervical cancer.
Region	Japan

Condition
Condition	Uterine cervical 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 cervical 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	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	Device,equipment
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	uterine cervical cancer (FIGO IA2, IB, IIA)
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	10

Research contact person
Name of lead principal investigator	Akira Iwase
Organization	Nagoya University Hospital
Division name	Maternal and Perinatal Medicine
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	Akira Iwase
Organization	Nagoya University Hospital
Division name	Maternal and Perinatal Medicine
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, Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization	Nagoya University Hospital
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	2015 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 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	2015 Year 01 Month 12 Day
Last modified on	2016 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018784