UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessments of usefulness and safety; a new concept in-bag laparoscopic surgery, which are inflated to the intraperitoneal isolation bag by CO2 pneumoperitoneum system.
Title of the study (Brief title)	Assessments of usefulness and safety; the inflated bag laparoscopic surgery.
Region	Japan

Condition
Condition	gynecologic disease, benign
Classification by specialty	Obsterics 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	Yoshikazu Ichikawa
Organization	Japanese Red Cross, Shizuoka hospital
Division name	obstetrics and gynecology
Address	8-2, Ohtemachi, Aoi-ku, Shizuoka
TEL	054-254-4311
Email	ichikawa-obgyn@szrc.org

Public contact
Name of contact person	Yoshikazu Ichikawa
Organization	Japanese Red Cross, Shizuoka hospital
Division name	obstetrics and gynecology
Address	8-2, Ohtemachi, Aoi-ku, Shizuoka
TEL	054-254-4311
Homepage URL
Email	ichikawa-obgyn@szrc.org

Sponsor
Institute	Japanese Red Cross, Shizuoka hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023460