Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001121459
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
17/08/2016
Date last updated
17/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
vaginal surgery for uterine prolapse in low resource countries using a new technique
Scientific title
vaginal hysterectomy with sacrospinous ligament fixation using needle holder in low resource countries for uterine prolapse
Secondary ID [1] 289616 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uterine prolapse 299191 0
Condition category
Condition code
Reproductive Health and Childbirth 299200 299200 0 0
Other reproductive health and childbirth disorders
Surgery 299621 299621 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
vaginal hysterectomy with unilateral right sacrospinous ligament fixation will be performed using long needle holder through long posterior vaginal wall incision and suturing back of the cervix to the ligament using vicryl one suture ,the surgery will be performed in shatby maternity university hospital,Alexandria university ,egypt. the surgery will be done by a gynecologist with 5 years of experience .the approximate duration of the procedure is 1.5 hour
Intervention code [1] 295080 0
Treatment: Surgery
Intervention code [2] 295222 0
Treatment: Devices
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298677 0
failure rate by recurrence of symptoms and examination from medical records .
Timepoint [1] 298677 0
recurrence of prolapse 3 month,6 month and ,one year after surgery
Secondary outcome [1] 324943 0
complications as needle injury to the physician,blood loss,hematoma with blood transfusion and chronic pelvic pain from medical records
Timepoint [1] 324943 0
during surgery ,baseline,one week after surgery ,and 3 month after surgery
Secondary outcome [2] 325396 0
duration of surgery from medical records
Timepoint [2] 325396 0
during surgery

Eligibility
Key inclusion criteria
1.second and third degree uterine prolapse .
2.HCV,HBV,HIV negative
3.not desiring fertility
4.no coital complains
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. previous failure of ligament fixation.

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/05/2015
Date of last participant enrolment
Anticipated
6/09/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 7970 0
Egypt
State/province [1] 7970 0
shatby alexandria univeristy hospital,alexandria,egypt

Funding & Sponsors
Funding source category [1] 293861 0
Hospital
Name [1] 293861 0
shatby maternity university hospital
Country [1] 293861 0
Egypt
Primary sponsor type
Individual
Name
Ahmed samy el-agwany
Address
shatby maternity university hospital,department of obstetrics and gynecology,alexandria egypt.20255
Country
Egypt
Secondary sponsor category [1] 292812 0
Hospital
Name [1] 292812 0
shatby hospital
Address [1] 292812 0
shatby maternity university hospital,department of obstetrics and gynecology,alexandria egypt.20255
Country [1] 292812 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295286 0
alexandria university ethics committee
Ethics committee address [1] 295286 0
Ethics committee country [1] 295286 0
Egypt
Date submitted for ethics approval [1] 295286 0
10/04/2015
Approval date [1] 295286 0
20/04/2015
Ethics approval number [1] 295286 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66770 0
Dr ahmed elagwany
Address 66770 0
shatby maternity university hospital,department of obstetrics and gynecology,alexandria egypt.20255
Country 66770 0
Egypt
Phone 66770 0
+201228254247
Fax 66770 0
Email 66770 0
[email protected]
Contact person for public queries
Name 66771 0
ahmed elagwany
Address 66771 0
shatby maternity university hospital,department of obstetrics and gynecology,alexandria egypt.20255
Country 66771 0
Egypt
Phone 66771 0
+201228254247
Fax 66771 0
Email 66771 0
[email protected]
Contact person for scientific queries
Name 66772 0
ahmed elagwany
Address 66772 0
shatby maternity university hospital,department of obstetrics and gynecology,alexandria egypt.20255
Country 66772 0
Egypt
Phone 66772 0
+201228254247
Fax 66772 0
Email 66772 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.