Uterine ProlapseNCT03494582
Abdominal Versus Vaginal Hysteropexy
A study testing Sacral Hysteropexy and sacrospinous Hysteropexy in people with Uterine Prolapse, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Uterine Prolapse
- What is being tested?
- Sacral Hysteropexy and sacrospinous Hysteropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Uterine Prolapse
Who cannot join
- Previous prolapse surgery Hereditary Connective tissue disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse
This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse
Read the detailed description
this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse
- Conditions
- Uterine Prolapse
- Being tested
- Sacral Hysteropexy, sacrospinous Hysteropexy
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral HysteropexyProcedure or surgery
Abdominal approach for uterine suspension
sacrospinous HysteropexyProcedure or surgery
Transvaginal approach for uterine suspension
| Study group | Role | What they receive |
|---|---|---|
| Sacral Hysteropexy | Experimental | Abdominal approach for uterine suspension Receives: Procedure: Sacral Hysteropexy |
| sacrospinous Hysteropexy | Experimental | Transvaginal approach for uterine suspension Receives: Procedure: sacrospinous Hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic organ prolapse quantification system
compare Pelvic organ prolapse quantification system between groups
Measured: 3 month
Secondary outcomes (2)
Perioperative data
operative time
Measured: 1 day
operative details
blood loss
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Apr 2017
- Primary completion1 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdy Ahmed Saaid, Ain Shams Maternity Hospital
- Investigators
- Hamdy HA Ahmed, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494582
- Sponsor's protocol ID
- AVVCP
- Status last verified
- Nov 2018
- First submitted
- 29 Mar 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse
- ClinicalTrials.gov ID
- NCT03494582
- Acronym / sponsor ID
- AVVCP
- Conditions
- Uterine Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse
Detailed description
this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral Hysteropexy | Experimental | Procedure: Sacral HysteropexyAbdominal approach for uterine suspension |
| sacrospinous Hysteropexy | Experimental | Procedure: sacrospinous HysteropexyTransvaginal approach for uterine suspension |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Uterine Prolapse
Key exclusion criteria (1 listed)
- Previous prolapse surgery Hereditary Connective tissue disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral HysteropexyAbdominal approach for uterine suspension | Procedure or surgery | Sacral Hysteropexy |
| sacrospinous HysteropexyTransvaginal approach for uterine suspension | Procedure or surgery | sacrospinous Hysteropexy |
Primary outcome
Pelvic organ prolapse quantification system
Time frame: 3 month
compare Pelvic organ prolapse quantification system between groups
2 secondary outcomes
Perioperative data
Time frame: 1 day
operative details
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamdy HA Ahmed, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Hysteropexy and sacrospinous Hysteropexy in people with Uterine Prolapse, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic organ prolapse quantification system (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.