UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039524
Receipt number R000044833
Scientific Title Assessment of suppressive effect of warming Tri-Lumen tube on mist increased in abdominal cavity and water drop generated on access port during using AirSeal system under laparoscopic surgery
Date of disclosure of the study information 2020/03/01
Last modified on 2021/08/23 09:28:16

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Basic information

Public title

Assessment of suppressive effect of warming Tri-lumen tube on mist increased in abdominal cavity and water drop generated on access port during using AirSeal system under laparoscopic surgery

Acronym

Airseal tube warming study

Scientific Title

Assessment of suppressive effect of warming Tri-Lumen tube on mist increased in abdominal cavity and water drop generated on access port during using AirSeal system under laparoscopic surgery

Scientific Title:Acronym

Airseal tube warming study

Region

Japan


Condition

Condition

colon cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to assess the warming effect of Tri-lumen tube attached with AirSeal on mist and water drops which impairs surgical view and procedures.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Weight of water drops generated on access port

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In warming group, Tri-lumen tube of Airseal is warmed at 37 degree celsius for 2 hours.

Interventions/Control_2

In control group, Tri-lumen tube is not warmed.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo laparoscopic surgical therapy for colon cancer with AirSeal system are enrolled.

Key exclusion criteria

Based on surgeon's decision

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Nagano

Organization

Faculty of medicine,Fukuoka University

Division name

Dept of Gastroenterological Surgery

Zip code

8140180

Address

Nanakuma 7-45-1. Jonan, Fukuoka, JPN

TEL

0928011011

Email

hidekinagano@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Nagano

Organization

Faculty of medicine,Fukuoka University

Division name

Dept of Gastroenterological Surgery

Zip code

8140180

Address

Nanakuma 7-45-1. Jonan, Fukuoka, JPN

TEL

0928011011

Homepage URL


Email

hidekinagano@fukuoka-u.ac.jp


Sponsor or person

Institute

Dept of Gastroenterological Surgery
Faculty of medicine,Fukuoka University

Institute

Department

Personal name



Funding Source

Organization

Dept of Gastroenterological Surgery
Faculty of medicine,Fukuoka University

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

Medical Ethics Committee of Fukuoka University

Address

Nanakuma 7-45-1. Jonan, Fukuoka, JPN

Tel

0928011011

Email

fumed-ethics@fukuoka-u.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

福岡大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 01 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

2019 Year 09 Month 02 Day

Date of IRB

2019 Year 09 Month 17 Day

Anticipated trial start date

2019 Year 09 Month 17 Day

Last follow-up date

2023 Year 03 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

2020 Year 02 Month 18 Day

Last modified on

2021 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name