UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052263 |
|---|---|
| Receipt number | R000059657 |
| Scientific Title | A Study of Drains in Reconstructive Surgery for Head and Neck Cancer |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2025/03/24 11:38:19 |
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Basic information
Public title
A Study of Drains in Reconstructive Surgery for Head and Neck Cancer
Acronym
A Study of Drains in Reconstructive Surgery for Head and Neck Cancer
Scientific Title
A Study of Drains in Reconstructive Surgery for Head and Neck Cancer
Scientific Title:Acronym
A Study of Drains in Reconstructive Surgery for Head and Neck Cancer
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Oral surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the more appropriate number of days for drain placement in head and neck cancer reconstructive surgery by statistically comparing the group that had the drain removed on the third postoperative day with the group that had the drain removed on the second postoperative day in head and neck cancer reconstruction surgery performed at our institution.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between drain tip culture-detected bacteria and surgical site infection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of surgical site infection
Key secondary outcomes
Demographic indicators, complication rates, information on radiation therapy or chemoradiation, information on surgical procedures, information on chemotherapy, other drugs and supplements administered, information on medical history
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
| Device,equipment | Maneuver |
Interventions/Control_1
In most cases, drains placed after reconstructive surgery for head and neck cancer are removed on the third postoperative day at our institution, and the drain tip is cultured. Since the start of the study, drains placed after reconstructive surgery for head and neck cancer are removed on the second postoperative day.
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
Adult patients who have undergone head and neck cancer reconstruction at our institution and have given written consent
Key exclusion criteria
Patients who did not have a drain placed or who had inadequate medical records
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Ishida |
Organization
The Jikei University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
105-8461
Address
Nishi-shimbashi 3-25-8, Minato-ku, Tokyo
TEL
+81334331111
katsu07@hotmail.com
Public contact
Name of contact person
| 1st name | Haruyuki |
| Middle name | |
| Last name | Hirayama |
Organization
The Jikei University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
105-8461
Address
Nishi-shimbashi 3-25-8, Minato-ku, Tokyo
TEL
+81334331111
Homepage URL
qbqxr344@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
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
The Jikei University School of Medicine, research ethics committee
Address
3-19-18, Nishishimbashi,Minato-ku,Tokyo
Tel
+81334331111
rinri@jikei.ac.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
東京慈恵会医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
220
Results
The positive rate of drain tip cultures was significantly greater in the POD3 group (38.2%) compared with the POD2 group (18.0%). Multi-variable analysis showed no correlation between SSI and POD3 drain removal (odds ratio [OR], 0.728; p = 0.471). However, significant SSI risk factors included oral cavity lesions (OR, 3.510; p = 0.003) and ampicillin prophylaxis (OR, 5.266; p < 0.001).
Results date posted
| 2025 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 24 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059657
