UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056803 |
|---|---|
| Receipt number | R000064920 |
| Scientific Title | Prospective interventional study to assess the impact of introducing an Enhanced Recovery After Surgery (ERAS) program on post-operative complications and prognosis in patients with oral surgical diseases |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/07/26 11:04:30 |
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Basic information
Public title
Prospective interventional study to assess the impact of introducing an Enhanced Recovery After Surgery (ERAS) program on post-operative complications and prognosis in patients with oral surgical diseases
Acronym
Kagoshima University Oral Surgery ERAS Protocol
Scientific Title
Prospective interventional study to assess the impact of introducing an Enhanced Recovery After Surgery (ERAS) program on post-operative complications and prognosis in patients with oral surgical diseases
Scientific Title:Acronym
Kagoshima University Oral Surgery ERAS Protocol
Region
| Japan |
Condition
Condition
Patients undergoing surgery under general anaesthesia at the Department of Oral Surgery, Kagoshima University Hospital
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to adapt correct nutritional assessment and based ERAS protocols to patients with oral diseases and assess their association with complications and prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(i) Post-operative hospital stay (number of days until the patient is diagnosed as ready for discharge).
(ii) Postoperative complications (pain, bleeding, postoperative infection, wound healing, postoperative nausea and vomiting, organ damage, degree of invasion)
(iii) Prognosis (overall survival, disease-specific survival, disease-free survival).
Key secondary outcomes
(i) timing and method of initiation of oral and enteral nutrition (including level of independence in nutritional intake)
2) Patient satisfaction (assessment of quality of life)
(iii) ERAS achievement rate
(iv) Level of independence at discharge
(5) Volume of infusion (In/Out balance)
(vi) Inflammatory reaction due to surgery
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
Preoperative drinking of oral rehydration fluid (clarified water with whey protein or clarified water with maldextrin)
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
Patients undergoing surgery under general anaesthesia for diseases of the oral and maxillofacial region
Key exclusion criteria
(i) Cases with active infections (tuberculosis, viral or fungal infections).
(ii) Cases with a history of poorly controlled diabetes mellitus such as type 1 diabetes mellitus
(iii) Patients taking steroids due to autoimmune diseases
(iv) Cases with allergy to steroids
(v) Women who are pregnant, possibly pregnant, within 28 days postpartum or breastfeeding
(vi) Cases with thrombosis, poorly controlled glaucoma or active gastrointestinal ulcer
(vii) Subjects deemed unlikely to participate in the study due to psychosis or psychiatric symptoms
(viii) Other subjects deemed ineligible by the doctor/dentist.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Okui |
Organization
Kagoshima University
Division name
Oral surgery
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture, Japan
TEL
099-275-6232
tokui@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Takaoka |
Organization
Kagoshima University
Division name
Oral surgery
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture, Japan
TEL
099-275-6232
Homepage URL
179618132ryota@gmail.com
Sponsor or person
Institute
Kagoshima University
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
Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture, Japan
Tel
0992756232
179618132ryota@gmail.com
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
| 2025 | Year | 02 | Month | 01 | 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
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2040 | 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
| 2025 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064920
