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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028306 |
Receipt No. | R000032355 |
Scientific Title | Single center, exploratory research of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery |
Date of disclosure of the study information | 2017/07/21 |
Last modified on | 2019/07/25 |
Basic information | ||
Public title | Single center, exploratory research of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery | |
Acronym | Single center, exploratory research of pre- and intra-operative neck warming | |
Scientific Title | Single center, exploratory research of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery | |
Scientific Title:Acronym | Single center, exploratory research of pre- and intra-operative neck warming | |
Region |
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Condition | ||
Condition | Laparoscopic abdominal surgery
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Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine the efficacy of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | the incidence of perioperative hypothermia |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Pre- and intra-operative warming by neck warmer with disposable heating pad with standard warming
Neck warmer are started about 150 min before the expected start of surgery and maintain until the end of anesthesia |
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Interventions/Control_2 | standard warming: precordial warming with forced-air cover which is started at induction of general anesthesia and maintain until the end of anesthesia
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. American Society of Anesthesiologists (ASA) physical status 1,2
2. Laparoscopic abdominal surgery with an expected duration of at least 120 min 3. Combined general and epidural anesthesia 4. Written informed consent |
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Key exclusion criteria | 1. Emergency operation
2. Without epidural anaesthesia 3. Body mass index under 18 4. Body mass index over 35 5. Preoperative fever (>38 degrees) 6. Current infection 7. Thyroid disease 8. Arteriosclerosis obliterans 9. Diabetes Mellitus 10. Using acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroid 11. Cervical central venous catheter 12. Cervical skin disorder 13. History of burns by disposable heating pad |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hiroshima University Hospital | ||||||
Division name | Department of Infectous Diseases | ||||||
Zip code | |||||||
Address | Kasumi 1-2-3, Minami-ku, Hiroshima City, Hiroshima, Japan | ||||||
TEL | 082-257-1613 | ||||||
ohge@hiroshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hiroshima University Hospital | ||||||
Division name | Deparment of Gastrointestinal Surgery | ||||||
Zip code | |||||||
Address | Kasumi 1-2-3, Minami-ku, Hiroshima City, Hiroshima, Japan | ||||||
TEL | 082-257-5216 | ||||||
Homepage URL | |||||||
hkitaga@hiroshima-u.ac.jp |
Sponsor | |
Institute | Hiroshima University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Education, Culture, Sports, Science and Technology |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032355 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |