UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020317 |
|---|---|
| Receipt number | R000023460 |
| Scientific Title | Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system. |
| Date of disclosure of the study information | 2015/12/23 |
| Last modified on | 2018/11/20 03:19:03 |
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Basic information
Public title
Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system.
Acronym
Assessments of usefulness and safety; the inflated bag laparoscopic surgery.
Scientific Title
Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system.
Scientific Title:Acronym
Assessments of usefulness and safety; the inflated bag laparoscopic surgery.
Region
| Japan |
Condition
Condition
gynecologic disease, benign
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness and safety of in bag morcellation used inflated intraperitoneal isolation bag in the gynecologic laparoscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
status of vital sign in the operation, included pressures of the intraperitoneum and the airway.
Key secondary outcomes
surgical duration
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
| Device,equipment | Maneuver |
Interventions/Control_1
using the intraperitoneal isolation bag inflated by CO2 pneumoperitoneum system
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Patients which need the tumor morcellation in the peritoneal cavity
Key exclusion criteria
patients which have not to use inflated isolation bag
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ichikawa |
Organization
Japanese Red Cross, Shizuoka hospital
Division name
obstetrics and gynecology
Zip code
Address
8-2, Ohtemachi, Aoi-ku, Shizuoka
TEL
054-254-4311
ichikawa-obgyn@szrc.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ichikawa |
Organization
Japanese Red Cross, Shizuoka hospital
Division name
obstetrics and gynecology
Zip code
Address
8-2, Ohtemachi, Aoi-ku, Shizuoka
TEL
054-254-4311
Homepage URL
ichikawa-obgyn@szrc.org
Sponsor or person
Institute
Japanese Red Cross, Shizuoka hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
静岡赤十字病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 23 | 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
Our experiment will be terminated on Dec 31st, 2018. Because the bags had already been sold, which was allowed to inflate in the patient's abdominal cavity. The importance to continue the experimental treatment using non-authorization bag and off-label use bag disappeared.
Furthermore, the authorized inflatable bags were not able to make stable conditions in the patients abdominal cavities. Because we could not get the credible data on each tests, we could not show the safety and the effectiveness that were the purpose of the examination.
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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
We will terminated on December 31, 2018 from the viewpoint of compatibility to a new clinical trial law.
Management information
Registered date
| 2015 | Year | 12 | Month | 23 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023460
| 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 |
