UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001248 |
|---|---|
| Receipt number | R000001521 |
| Scientific Title | A comparing study between open and close of retroperitonium on lymphedema of the lower extremities after surgeries of both uterine cervical and endometrial cancer (a randomized study by multi-institutes) |
| Date of disclosure of the study information | 2011/12/31 |
| Last modified on | 2018/04/25 23:36:59 |
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Basic information
Public title
A comparing study between open and close of retroperitonium on lymphedema of the lower extremities after surgeries of both uterine cervical and endometrial cancer (a randomized study by multi-institutes)
Acronym
A comparing study on lympoedema of the lower extemities
Scientific Title
A comparing study between open and close of retroperitonium on lymphedema of the lower extremities after surgeries of both uterine cervical and endometrial cancer (a randomized study by multi-institutes)
Scientific Title:Acronym
A comparing study on lympoedema of the lower extemities
Region
| Japan |
Condition
Condition
uterine cervical and endometrial cancer
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objedtive of this study is to evaluate the bebefit of the open peritoneum method which is expected to decrease the incidence of lymphedema and to alleviate symptoms (randomized single-blind trial).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint of thes study is to compare the cumulative incidences of lymphedema between the open peritoneum method (including use of hyaluronic acid-carboxycellulose membrane) and the closed peritoneum method during anthree-year postoerative period. The lymphedema is diagnosed by medical doctors according to the criteria of this study.
Key secondary outcomes
The secondary endpoint of this stydy is as follows, evaluation of the degree of lymphedema, investigation of the relationship between the incidences of lymphocyst and lymphedema of lower extremities,investigation of the relationship between the incidences of Trichophyton infection on the foot and lympyedema of lower extremities.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Close of the retroperitoneum
Interventions/Control_2
open of the retroperitonemu
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patients who are performed pelvic lymh node dissection, with stage 1-2 squamous cell carcinoma or adenocarcinoma of uterine cervix.
2) Patients who are performed pelvic (with or without para aoritc) lymph node dissection, with endometrial carcinoma of uterine body.
3) Patoemts aged frp, 20 to 70, with Performance status 0, give consent in writing.(1 and/or 2) +3
Key exclusion criteria
1) Patients with a primary lymphedema or a past history of lymphedema due to infection. 2) Patients who are regarded as inadequate due to other reasons (e.g. severe varix of llower extremities).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sasaki |
Organization
The Tokyo Jikei University School of Medicine
Division name
Kashiwa Hospital, Dept. of OB. & GYN.
Zip code
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL
04-7164-1111
hrssasaki@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sasaki |
Organization
The Tokyo Jikei University School of Medicine
Division name
Kashiwa Hospital, Dept. of OB. & GYN.
Zip code
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba
TEL
04-7164-1111
Homepage URL
hrssasaki@jikei.ac.jp
Sponsor or person
Institute
The development reserarch cancer treatments aiming improvement of QOL
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare Third Research Project on General Strategy Against Cancer
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2011 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 14 | Day |
Last modified on
| 2018 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001521
