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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019708
Receipt No. R000022762
Scientific Title Hybrid NOTES (Natural Orifice Translumenal Endoscopic Surgery) for gynecologic surgery
Date of disclosure of the study information 2016/11/16
Last modified on 2018/08/17

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Basic information
Public title Hybrid NOTES (Natural Orifice Translumenal Endoscopic Surgery) for gynecologic surgery
Acronym Hybrid NOTES for gynecologic surgery
Scientific Title Hybrid NOTES (Natural Orifice Translumenal Endoscopic Surgery) for gynecologic surgery
Scientific Title:Acronym Hybrid NOTES for gynecologic surgery
Region
Japan

Condition
Condition ovarian cyst
PCOS
hydrosalpinx
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of Hybrid NOTES
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Time of surgery and anesthesia,blood loss,adverse events and convertion rates to conventional laparoscopy or laparotomy.
Key secondary outcomes Hospitalization,amount of pain killer after surgery and periods of time of recovery.

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 Hybrid NOTES
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 ovarian cyst that the size is less than 6cm, and occurs in unilateral ovary
PCOS
Hydrosalpinx
Written informed concent
Key exclusion criteria Advanced adhesions of ovary
Advanced obesity
Women who has not experience of sexual intercourse
Physician decision

Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazu Ueda
Organization The jikei university school of medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Email kazu@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazu Ueda
Organization The jikei university school of medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Homepage URL
Email kazu@jikei.ac.jp

Sponsor
Institute The jikei university 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2018 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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