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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026891
Receipt No. 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

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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
Obsterics 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
Email 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
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta university
department of obstetrics and gynecology
Institute
Department

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
Email 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
URL(English) https://upload.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


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