UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019708 |
|---|---|
| Receipt number | 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 | 2024/03/25 19:54:17 |
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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
| Obstetrics 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 8cm, 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 | KAZU |
| Middle name | |
| Last name | Ueda |
Organization
The jikei university school of medicine
Division name
Department of Obstetrics and Gynecology
Zip code
105-8471
Address
3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL
+81-3-3433-1111
kazu@jikei.ac.jp
Public contact
Name of contact person
| 1st name | KAZU |
| Middle name | |
| Last name | Ueda |
Organization
The jikei university school of medicine
Division name
Department of Obstetrics and Gynecology
Zip code
105-8471
Address
3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL
+81-3-3433-1111
Homepage URL
kazu@jikei.ac.jp
Sponsor or person
Institute
The jikei university school of medicine
Institute
Department
Personal name
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
The jikei university school of medicine
Address
3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
Tel
+81334331111
kazu@jikei.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
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
| 2015 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
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
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
