Uterine FibroidNCT02371811
Use of v Care in Abdominal Hysterectomy
A study testing uterine manipulator (v care) in people with Uterine Fibroid, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- uterine manipulator (v care)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Jul 2017
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- benign causes for hysterectomy
Who cannot join
- malignant causes for hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.
- Conditions
- Uterine Fibroid
- Being tested
- uterine manipulator (v care)
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine manipulator (v care)Device
Also called v care
| Study group | Role | What they receive |
|---|---|---|
| v care group | Experimental | In this group we will use (v care) uterine manipulator during abdominal hysterectomy. Receives: Device: uterine manipulator (v care) |
| control group | No intervention | In this group we will do abdominal hysterectomy without v care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal length
Measured: within 1 week postoperative
Secondary outcomes (1)
Bladder injury
Measured: within 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohammed elsafty, Ain Shams Maternity Hospital
- Investigators
- mohammed elsafty, md, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371811
- Sponsor's protocol ID
- m2491
- Status last verified
- Jul 2017
- First submitted
- 17 Feb 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of v Care in Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT02371811
- Acronym / sponsor ID
- m2491
- Conditions
- Uterine Fibroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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.
The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| v care group | Experimental | Device: uterine manipulator (v care)In this group we will use (v care) uterine manipulator during abdominal hysterectomy. |
| control group | No intervention | –In this group we will do abdominal hysterectomy without v care. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- benign causes for hysterectomy
Key exclusion criteria (1 listed)
- malignant causes for hysterectomy
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 |
|---|---|---|
| uterine manipulator (v care)Also: v care | Device | v care group |
Primary outcome
Vaginal length
Time frame: within 1 week postoperative
1 secondary outcome
Bladder injury
Time frame: within 1 week postoperative
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 1 Aug 2017.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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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.
mohammed elsafty, 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 uterine manipulator (v care) in people with Uterine Fibroid, 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 1 Aug 2017. 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?
Vaginal length (time frame: within 1 week postoperative). 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 1 Aug 2017.