UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040790
Receipt number R000045850
Scientific Title Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study
Date of disclosure of the study information 2020/06/17
Last modified on 2021/05/17 15:34:28

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Basic information

Public title

Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study

Acronym

Efficacy of a novel neck-warming device in preventing perioperative hypothermia

Scientific Title

Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study

Scientific Title:Acronym

Efficacy of a novel neck-warming device in preventing perioperative hypothermia

Region

Japan


Condition

Condition

Patients undergoing elective laparoscopic colorectal surgery

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To invesigate the efficacy of a novel neck-warming device in preventing perioperative hypothermia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of patients who did not show perioperative hypothermia (core temperature < 36 degrees)

Key secondary outcomes

Perioperative core temperature, Area under the curve of perioperative core temperature, Safety


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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Neck warming during entire perioperative period from prewarming in the surgical ward until leaving the operation room. Neck prewarming start in the patients room 60 minutes before leaving to the operating room.

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

Male and Female

Key inclusion criteria

20-80 years of age at the time of agreement to participate, American Society of Anesthesiologists physical status I or II, surgical procedures scheduled for more than 2 hours, undergoing elective laparoscopic colorectal surgery under epidural and eneral anesthesia that was scheduled as the first surgery of the day

Key exclusion criteria

Emergency surgery patient, body mass index <18 kg/m2 or >35 kg/m2, evidence of current infection, known metabolic disorders (e.g., hyperthyroidism or hypothyroidism), known inflammatory bowel disease, current medications interfering with normal thermoregulation (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs, or steroids), the presence of a peripherally inserted central venous catheter, the presence of skin or soft tissue disorders in areas to be covered with the neck warmer, or a history of burn by hot packs.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Ohge

Organization

Hiroshima University Hospital

Division name

Department of infection diseases

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN

TEL

0822571613

Email

ohge@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Kitagawa

Organization

Hiroshima University

Division name

Department of infection diseases

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN

TEL

0822571613

Homepage URL


Email

hkitaga@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital, Department of infection diseases

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University Hospital, Department of infectious diseases

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

Independent Ethics Committee, Hiroshima University Hospital

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN

Tel

082-257-5907

Email

iryo-seisaku@office.hiroshima-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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 17 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

2020 Year 04 Month 22 Day

Date of IRB

2020 Year 05 Month 28 Day

Anticipated trial start date

2020 Year 06 Month 15 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 06 Month 16 Day

Last modified on

2021 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045850


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name