Myoma;UterusNCT03009812
Transverse vs Longitudinal Incision in Myomectomy
A study testing Longitudinal uterine incision and Transverse uterine incision in people with Myoma;Uterus, run by Ain Shams University.
Trial summary
The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Longitudinal uterine incision and Transverse uterine incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 23 Jan 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old
- Single myoma.
- Women with BMI between 18.5-29.9 kg/m2.
Who cannot join
- Pregnancy.
- Patients with bleeding tendency
- Previous laparotomies.
- Patients with concomitant pelvic pathologies, such as ovarian cysts.
About this study
Official title: Transverse Versus Longitudinal Uterine Incision in Abdominal Myomectomy
The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.
- Conditions
- Myoma;Uterus
- Being tested
- Longitudinal uterine incision, Transverse uterine incision
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal uterine incisionProcedure or surgery
Transverse uterine incisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 26 subjects who are planned for transverse uterine incision Receives: Procedure: Transverse uterine incision |
| Group 2 | Active comparator | 26 subjects who are planned for longitudinal uterine incision Receives: Procedure: Longitudinal uterine incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myoma;UterusStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maii medhat nawara, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009812
- Sponsor's protocol ID
- MY-789
- Status last verified
- Apr 2019
- First submitted
- 1 Jan 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Elguindy A, Hemeda H, Shawky ME, Elsenity M, Elsayed MA, Fahim A, Afifi K, Nawara M. Blood loss from transverse versus longitudinal uterine incision in abdominal myomectomy: a randomized controlled trial. BMC Womens Health. 2020 Dec 28;20(1):259. doi: 10.1186/s12905-020-01113-3.
PubMed 33357218
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Versus Longitudinal Uterine Incision in Abdominal Myomectomy
- ClinicalTrials.gov ID
- NCT03009812
- Acronym / sponsor ID
- MY-789
- Conditions
- Myoma;Uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 4 Jan 2017 (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 Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Transverse uterine incision26 subjects who are planned for transverse uterine incision |
| Group 2 | Active comparator | Procedure: Longitudinal uterine incision26 subjects who are planned for longitudinal uterine incision |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old
- Single myoma.
- Women with BMI between 18.5-29.9 kg/m2.
Key exclusion criteria (4 listed)
- Pregnancy.
- Patients with bleeding tendency
- Previous laparotomies.
- Patients with concomitant pelvic pathologies, such as ovarian cysts.
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 |
|---|---|---|
| Longitudinal uterine incision | Procedure or surgery | Group 2 |
| Transverse uterine incision | Procedure or surgery | Group 1 |
Primary outcome
Intraoperative blood loss
Time frame: 1 year
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 8 Apr 2019.
- Derived from this study: PubMed 33357218Elguindy A, Hemeda H, Shawky ME, Elsenity M, Elsayed MA, Fahim A, Afifi K, Nawara M. Blood loss from transverse versus longitudinal uterine incision in abdominal myomectomy: a randomized controlled trial. BMC Womens Health. 2020 Dec 28;20(1):259. doi: 10.1186/s12905-020-01113-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal uterine incision and Transverse uterine incision in people with Myoma;Uterus, run by Ain Shams University.
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 3 inclusion and 4 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Intraoperative blood loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009812, which also lists 1 linked publication.
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 8 Apr 2019.