UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046989 |
|---|---|
| Receipt number | R000051113 |
| Scientific Title | Effect of bilateral compression maneuver after esophagectomy for esophageal carcinoma. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/02/26 10:14:53 |
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Basic information
Public title
Effect of bilateral compression maneuver after esophagectomy for esophageal carcinoma.
Acronym
Cough assist method after esophagectomy for esophageal carcinoma.
Scientific Title
Effect of bilateral compression maneuver after esophagectomy for esophageal carcinoma.
Scientific Title:Acronym
Bilateral compression maneuver after esophagectomy for esophageal carcinoma.
Region
| Japan |
Condition
Condition
Esophageal carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of bilateral abdominal compression maneuver
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score on postoperative day 1, 3, 5 and 7.
Key secondary outcomes
a quality measure of multidimensional scale recovery, recovery rate of peak cough flow, and vital capacity ,on postoperative day 1, 3, 5 and 7.
Relationship between bilateral abdominal compression maneuver and age, gender, surgical procedure (presence or absence of cervical dissection, thoracotomy / non-thoracotomy, laparotomy / laparoscope), wound size, type of postoperative analgesia, dosage and administration of analgesia, past history, ICU admission period, postoperative hospitalization period , postoperative respiratory complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Evaluate the pain score on coughing and respiratory function with the bilateral flank compression maneuver.
Interventions/Control_2
Evaluate the pain score on coughing and respiratory function with the thoracic compression maneuver
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
The patients who undergo esophagectomy for esophageal carcinoma.
The patients consent from the person who has been obtained before the study registration in writing.
Key exclusion criteria
The patient who undergo emergency operation.
The patients who cannot compress their bilateral flank or thorax (e.g., heavily sedated or physically restrained).
The patients who are unable to assess pain due to sedation, dementia or psychosis.
The patients who refuse to the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ueno |
| Middle name | |
| Last name | Masaki |
Organization
Toranomon hospital
Division name
Gastroenterological surgery
Zip code
1058470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
ueno@toranomo.gr.jp
Public contact
Name of contact person
| 1st name | Shimoyama |
| Middle name | |
| Last name | Hayato |
Organization
Toranomon hospital
Division name
Gastroenterological surgery
Zip code
1058470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
hayatos0124@gmail.com
Sponsor or person
Institute
Toranomon hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon hospital
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
Toranomon hospital, Department of Clinical Trial and Research
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim2@toranomon.gr.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
虎の門病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
| 2021 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051113
