UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030467 |
|---|---|
| Receipt number | 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 | 2021/06/29 14:25:19 |
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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 | Takayuki |
| Middle name | |
| Last name | Imai |
Organization
Miyagi Cancer Center
Division name
Head and Neck Surgery
Zip code
981-1293
Address
47-1 Nodayama, Medeshima-Shiode, Natori, Miyagi, Japan
TEL
022-384-3151
takayuki.imai629@gmail.com
Public contact
Name of contact person
| 1st name | Imai |
| Middle name | |
| Last name | Takayuki |
Organization
Miyagi Cancer Center
Division name
Head and Neck Surgery
Zip code
981-1293
Address
47-1 Nodayama, Medeshima-Shiode, Natori, Miyagi, Japan
TEL
022-384-3151
Homepage URL
takayuki.imai629@gmail.com
Sponsor or person
Institute
Miyagi Cancer Center
Institute
Department
Personal name
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
Ethics review committee, Miyagi Cancer Center
Address
47-1 Nodayama, Medeshima-Shiode, Natori, Miyagi, Japan
Tel
022-384-3151
mcc-rinri1@miyagi-pho.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
| 2017 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0960740419305456?via%3Dihub
Number of participants that the trial has enrolled
60
Results
The duration of hospital stay: Median 25 days.
The duration until completion of the discharge criteria: Median 17 days.
Early mobilization: 86.0% (POD1), 96.5% (POD2).
Enteral nutrition: 80.1% (POD1), 100% (POD2). Postoperative pain: Mean VAS scores of 1.51 to 3.13.
Clavien Dindo grade II or higher postoperative complications: 27.6% of the patients.
The mean QOR40 score: 179.6 preoperatively, 146.1 at POD3, and 167.8 at POD7.
Results date posted
| 2021 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender: Male 47, Female 10
Age: Average 64, Median 65
Primary Site: Oral Cavity 27, Oropharynx 14, Larynx, Hypopharynx, and Cervical Esophagus 15, Nasal Cavity and Paranasal Sinus 1
Operation time: Mean 9h :35m, Median 9h: 28m
Blood loss: Mean 230 mL, Median 180 mL
History of head and neck irradiation: Yes 8, No 49
Participant flow
Fifty-seven patients completed the ERAS program out of the 60 patients who agreed to participate in this study. Among the three patients who were excluded, two were the patients whose surgeries were changed from free tissue transfer to pedicled myocutaneous flap after obtaining consent, and one was a patient who was transferred to another hospital that specialized in heart disease because of cardiovascular complications on POD2.
Adverse events
Clavian Dindo grade IV Postoperative complication: 1 case
The final diagnosis of patient who was transferred to another hospital that specialized in heart disease was C D grade 2 supraventricular arrhythmia.
Outcome measures
Primary outcomes: The duration of hospital stay after surgery and the duration until the completion of discharge criteria after surgery.
Another outcomes: Patients' mobility, Enteral nutrition, Postoperative nausea and vomiting, Postoperative pain, Postoperative complications, QOR40 J score.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 22 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034789
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