UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030467
Receipt No. R000034789
Scientific Title Prospective interventional study assessing the effectiveness on ameliorating surgical stress and the enhancement of recovery after surgery by Miyagi Cancer Center Head and Neck ERAS Protocol (MCC-HN ERAS)
Date of disclosure of the study information 2017/12/19
Last modified on 2019/06/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective interventional study assessing the effectiveness on ameliorating surgical stress and the enhancement of recovery after surgery by Miyagi Cancer Center Head and Neck ERAS Protocol (MCC-HN ERAS)
Acronym ERAS protocol for head and neck cancer at Miyagi Cancer Center (MCC-HN-ERAS)
Scientific Title Prospective interventional study assessing the effectiveness on ameliorating surgical stress and the enhancement of recovery after surgery by Miyagi Cancer Center Head and Neck ERAS Protocol (MCC-HN ERAS)
Scientific Title:Acronym ERAS protocol for head and neck cancer at Miyagi Cancer Center (MCC-HN-ERAS)
Region
Japan

Condition
Condition Head and Neck Cancers
Classification by specialty
Oto-rhino-laryngology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether the MCC-HN-ERAS protocol can ameliorate the surgical stress and enhance the postoperative recovery after the head and neck surgery involving the tumor resection and free tissue transfer reconstruction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Postoperative period to discharge.
2)Postoperative period to the day meeting the discharge criteria.
Key secondary outcomes 1) Postoperative patients' satisfaction rating (QoR-40 score)
2) Inflammatory response as surgical invasiveness
3) Pain control
4) Postoperative nausea and vomiting
5) Postoperative period until the commencement of enteral nutrition
6) Nutritional intake independence
7) Daily activities independence
8) Water balance
9) Organ disorder
10) Postoperative complication
11) Protocol compliance rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Food Behavior,custom
Other
Interventions/Control_1 Intervention with MCC-HN-ERAS protocol.
1) Preoperative administration of dexamethasone.
2) Preoperative oral rehydration.
3) Promotion of gastrointestinal peristalsis.
4) Stylization of pain assessment and pain control.
5) Measures against nausea and vomiting.
6) Early mobilization.
7) Early enteral feeding.
8) Cross-entry checklist among patients and medical staff.
9) Postoperative patients' satisfaction rating (QoR-40 score). etc.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Head and neck cancer patients who receive the surgeries with primary resection and free tissue transfer reconstruction.
2) Patients with written informed consent.
Key exclusion criteria 1) Patients with hypersensitivity to dexamethasone.
2) Patients with active infectious diseases such as tuberculosis, viral infection and mycosis.
3) Patients with thrombosis.
4) Patients with poor-controlled diabetes mellitus; e.g. insulin dependent.
5) Patients with uncontrolled psycogenic disease, such as depression.
6) Patients with active peptic ulcer.
7) Patients with uncontrolled glaucoma.
8) Patients with regular use of oral steroid for such conditions as autoimmune disease.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Imai
Organization Miyagi Cancer Center
Division name Head and Neck Surgery
Zip code
Address 47-1 Nodayama, Medeshima-Shiode, Natori, Miyagi, Japan
TEL 022-384-3151
Email takayuki.imai629@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Imai
Organization Miyagi Cancer Center
Division name Head and Neck Surgery
Zip code
Address 47-1 Nodayama, Medeshima-Shiode, Natori, Miyagi, Japan
TEL 022-384-3151
Homepage URL
Email takayuki.imai629@gmail.com

Sponsor
Institute Miyagi Cancer Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 19 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 60
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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034789

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.