UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054824 |
|---|---|
| Receipt number | R000062646 |
| Scientific Title | Visualizing Developmental Course of Complications after Total Phayryngolaryngectomy with Free Jejunal Transfer: Analysis Using Comprehensive Complication Index |
| Date of disclosure of the study information | 2024/06/29 |
| Last modified on | 2024/06/29 15:40:35 |
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Basic information
Public title
Visualizing Developmental Course of Complications after Total Phayryngolaryngectomy with Free Jejunal Transfer: Analysis Using Comprehensive Complication Index
Acronym
Visualizing Developmental Course of Complications after Total Phayryngolaryngectomy with Free Jejunal Transfer: Analysis Using Comprehensive Complication Index
Scientific Title
Visualizing Developmental Course of Complications after Total Phayryngolaryngectomy with Free Jejunal Transfer: Analysis Using Comprehensive Complication Index
Scientific Title:Acronym
Visualizing Developmental Course of Complications after Total Phayryngolaryngectomy with Free Jejunal Transfer: Analysis Using Comprehensive Complication Index
Region
| Japan |
Condition
Condition
Hypopharyngeal cancer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To use the comprehensive complication index (CCI) to track the development of complications over time in patients undergoing TPL with FJT, and to categorize and predict severe postoperative complication courses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the identification of distinct postoperative complication trajectories using daily measurements of the CCI from postoperative day 1 to 30.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 200 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent TPL and FJT for biopsy-confirmed squamous cell carcinoma at our institution between January 1, 2018 and April 30, 2023.
Key exclusion criteria
(1) patients who underwent TPL and FJT in conjunction with total esophagectomy, and (2) patients with a history of total esophagectomy.
Target sample size
161
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Department of Plastic and Reconstructive Surgery
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL
+81-4-7133-1111
tahidaka1986@gmail.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Department of Plastic and Reconstructive Surgery
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL
+81-4-7133-1111
Homepage URL
tahidaka1986@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Tel
+81-4-7133-1111
tahidaka1986@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
| 2024 | Year | 06 | Month | 29 | 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
161
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using a group-based trajectory model, several distinct complication trajectories will be identified.
Management information
Registered date
| 2024 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | 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=R000062646
