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Trial registered on ANZCTR


Registration number
ACTRN12616001234404
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
5/09/2016
Date last updated
5/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cervical excision in pieces with total hysterectomy in obese patients
Scientific title
cervical excision in pieces with total hysterectomy for long cervix in deep pelvis with fibroid uterus in female obese patients
Secondary ID [1] 289614 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fibroid uterus 299192 0
obesity 299684 0
Condition category
Condition code
Reproductive Health and Childbirth 299201 299201 0 0
Other reproductive health and childbirth disorders
Surgery 299620 299620 0 0
Surgical techniques
Diet and Nutrition 299829 299829 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
cervical excision in pieces after sub total hysterectomy through laparotomy will be done by a gynecologist with 5 years of experience .this will be done in shatby maternity university hospital,alexandria ,egypt.the approximate duration of the procedure is one hour.
the cervical branches of the uterine arteries are ligated on both sides then excise the upper part of the cervix .then , ligation of the cervical branches in a lower level with excision of the rest of the cervix .
Intervention code [1] 295081 0
Treatment: Surgery
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298678 0
Success of the procedure, defined as successful completion of the total hysterectomy as judged by the surgeon.
Timepoint [1] 298678 0
immediately prior to wound closure
Secondary outcome [1] 324944 0
complications encountered as bleeding assessed by blood transfusion bladder injury and colon injury from medical records
Timepoint [1] 324944 0
during surgery and one week after surgery
Secondary outcome [2] 325394 0
duration of surgery from medical records
Timepoint [2] 325394 0
during surgery

Eligibility
Key inclusion criteria
1. fibroid uterus equals or larger than 12 weeks pregnant uterus size
2. obese patients with BMI >25
3. patient not desiring fertility
4. patient completed family size
5. intra-operative finding of long cervix with deep pelvis
Minimum age
45 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.not surgically fit.
2.dyspareunia .
3.coitus complains

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
1/03/2016
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 7971 0
Egypt
State/province [1] 7971 0
shatby alexandria univeristy hospital,alexandria,egypt

Funding & Sponsors
Funding source category [1] 293865 0
Hospital
Name [1] 293865 0
shatby maternity university hospital
Country [1] 293865 0
Egypt
Primary sponsor type
Individual
Name
AHMED SAMY EL-AGWANY
Address
shatby maternity univeristy hospital beside bibliotheca alexandrina ,department of obstetrics and gynecology ,alexandria university,alexandria,egypt,20255
Country
Egypt
Secondary sponsor category [1] 292694 0
Hospital
Name [1] 292694 0
shatby maternity univeristy hospital
Address [1] 292694 0
shatby maternity univeristy hospital beside bibliotheca alexandrina ,department of obstetrics and gynecology ,alexandria university,alexandria,egypt,20255
Country [1] 292694 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295287 0
alexandria university ethics committee
Ethics committee address [1] 295287 0
Ethics committee country [1] 295287 0
Egypt
Date submitted for ethics approval [1] 295287 0
Approval date [1] 295287 0
10/12/2015
Ethics approval number [1] 295287 0

Summary
Brief summary
this is a prospective interventional study where cervical excision in pieces will be performed in obese patients with long cervix and fibroid uterus with deep pelvis .this is mainly done for easy exposure ,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66774 0
Dr ahmed elagwany
Address 66774 0
shatby maternity univeristy hospital beside bibliotheca alexandrina ,department of obstetrics and gynecology ,alexandria university,alexandria,egypt,20255
Country 66774 0
Egypt
Phone 66774 0
+201228254247
Fax 66774 0
Email 66774 0
[email protected]
Contact person for public queries
Name 66775 0
ahmed elagwany
Address 66775 0
shatby maternity univeristy hospital beside bibliotheca alexandrina ,department of obstetrics and gynecology ,alexandria university,alexandria,egypt,20255
Country 66775 0
Egypt
Phone 66775 0
+201228254247
Fax 66775 0
Email 66775 0
[email protected]
Contact person for scientific queries
Name 66776 0
ahmed elagwany
Address 66776 0
shatby maternity univeristy hospital beside bibliotheca alexandrina ,department of obstetrics and gynecology ,alexandria university,alexandria,egypt,20255
Country 66776 0
Egypt
Phone 66776 0
+201228254247
Fax 66776 0
Email 66776 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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