UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020999 |
|---|---|
| Receipt number | R000024209 |
| Scientific Title | Nutritional management of para-aortic lymph node dissection in gynecological patients |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2016/06/21 22:03:24 |
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Basic information
Public title
Nutritional management of para-aortic lymph node dissection in gynecological patients
Acronym
Nutritional management of para-aortic lymph node dissection in gynecological patients
Scientific Title
Nutritional management of para-aortic lymph node dissection in gynecological patients
Scientific Title:Acronym
Nutritional management of para-aortic lymph node dissection in gynecological patients
Region
| Japan |
Condition
Condition
para-aortic lymph node dissection in gynecological patients
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety of nutrient administration in the postoperative management of para-aortic lymph node dissection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
In the period from the post- nutrients taking the start to the meal start
Changes in the nursing general observation item
Nausea , vomiting, intestinal peristalsis , abdominal pain , vaginal bleeding , wound bleeding , swelling , pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Conventionally, take a nutritional supplement in the period in which was a prohibited diet after surgery for the target patient
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
Female
Key inclusion criteria
1. para-aortic lymph node dissection in gynecological patients
2. Patients that can be taken orally
3. Patients mutual understanding can be
4. And it shall meet the above mentioned 1 ~ 3, have been adults , received a sufficient explanation Upon the present study , that obtained the consent of the document by the free will of the person
Key exclusion criteria
1. Patients who have been determined to organic impossible oral ingestion , including bowel resection
2. Patients suffering from diabetes
Fasting blood glucose > 200mg / dl, HbaA1c> 10%
3. Patients with renal dysfunction
Serum creatinine 0.171mol / L or more 1.9mg / dl
4. Patients who did not perform the surgery
5. Others , those principal investigator or team members is determined to be inappropriate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | mikio mikami |
Organization
tokai university hospital
Division name
Obstetrics and gynecology
Zip code
Address
Isehara, Kanagawa Shimokasuya 143
TEL
0463267968
asakuratokai@tokai-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yukimoto asakura |
Organization
tokai university hospital
Division name
Nursing department
Zip code
Address
Isehara, Kanagawa Shimokasuya 143
TEL
0463267968
Homepage URL
asakuratokai@tokai-u.jp
Sponsor or person
Institute
tokai university hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Address
Tel
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
| 2016 | Year | 02 | Month | 15 | 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
Although there is variation in the amount of drinking , without the emergence of adverse events
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
| 2016 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024209
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
