UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026891 |
|---|---|
| Receipt number | R000030849 |
| Scientific Title | Colpotomizer-assisted total abdominal hysterectomy (CATAH technique): A new technique in benign uterine pathologies |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2019/05/04 20:24:42 |
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Basic information
Public title
Colpotomizer-assisted total abdominal hysterectomy (CATAH technique): A new technique in benign uterine pathologies
Acronym
CATAH technique: A new technique in benign uterine pathologies
Scientific Title
Colpotomizer-assisted total abdominal hysterectomy (CATAH technique): A new technique in benign uterine pathologies
Scientific Title:Acronym
CATAH technique: A new technique in benign uterine pathologies
Region
| Africa |
Condition
Condition
Completed
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Colpotomizer-assisted total abdominal hysterectomy (CATAH); a new technique for uterine removal in benign uterine pathologies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
the feasibility of the technique, safety and operative time
Key secondary outcomes
intraoperative, postoperative complications and duration of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
will be operated by total abdominal hysterectomy using the new technique " colpotomizerassisted" to cut the cervix from the vagina easily with short time and less blood loss
Interventions/Control_2
will be treated by conventional total abdominal hysterectomy
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
| 40 | years-old | <= |
Age-upper limit
| 49 | years-old | > |
Gender
Female
Key inclusion criteria
patients accepting hysterectomy and suffering from benign uterine pathology, fit for surgery or failed medical therapy
Key exclusion criteria
patients with suspicious malignancy, unfit for surgery or refusing hysterstmy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta University
Division name
Ayma shehata dawood
Zip code
31111
Address
Tanta university
TEL
+201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Ayman shehata dawood
Zip code
31111
Address
Tanta university
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta university
department of obstetrics and gynecology
Institute
Department
Personal name
Funding Source
Organization
Tanta University
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
Tanta University
Address
Elgeish st., Tanta, Egypt
Tel
+201020972067
ayman.dawood@med.tanta.edu.eg
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
| 2017 | 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
88
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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 07 | Day |
Last modified on
| 2019 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030849
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/03/09 | TABLES.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
