UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005688 |
|---|---|
| Receipt number | R000006725 |
| Scientific Title | A prospective study of postoperative complications with abandoned peritoneal closure after retroperitoneal lymphadenectomy in patients with gynecologic malignancies |
| Date of disclosure of the study information | 2011/05/31 |
| Last modified on | 2014/12/02 08:19:27 |
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Basic information
Public title
A prospective study of postoperative complications with abandoned peritoneal closure after retroperitoneal lymphadenectomy in patients with gynecologic malignancies
Acronym
postoperative complications with abandoned peritoneal closure
Scientific Title
A prospective study of postoperative complications with abandoned peritoneal closure after retroperitoneal lymphadenectomy in patients with gynecologic malignancies
Scientific Title:Acronym
postoperative complications with abandoned peritoneal closure
Region
| Japan |
Condition
Condition
retroperitoneal lymphadenectomy in patients with gynecologic malignancies(cervical cancer, endometrial cancer, ovarian cancer, et al.)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the incidence of lymphocysts and to unvestigate postoperative complications with abandoned peritoneal closure after retroperitoneal lymphadenectomy in patients with gynecologic malignancies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the incidence of complications
Key secondary outcomes
the incidence and size of lymphocysts
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
| Maneuver |
Interventions/Control_1
June 1, 2011- May 31, 2013
100 cases
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
patients with gynecologic malignancies after retroperitoneal lymphadenectomy
Key exclusion criteria
Case who doesn't correspond to object patient's selection criterion
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Hirata |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
hiratatoru@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Hirata |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
Homepage URL
http://www.medic.mie-u.ac.jp/chiken/index.html
hiratatoru@hotmail.com
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Mie University School of Medicine
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
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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 31 | Day |
Last modified on
| 2014 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006725
