UMIN-CTR Clinical Trial

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
Email	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
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	Ethics review committee, Miyagi Cancer Center
Address	47-1 Nodayama, Medeshima-Shiode, Natori, Miyagi, Japan
Tel	022-384-3151
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034789