MyomectomyNCT07365969
Risk of Hysterectomy at Time of Myomectomy
An observational study of Myomectomy and Fibroid Uterus, run by Ain Shams University at 1 site in Egypt.
Trial summary
Uterine fibroids are the commonest tumor affecting the female reproductive tract and many instances they are asymptomatic but in some women there does appear to be an association with heavy menstrual blood loss and possibly subfertility. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Myomectomy, Fibroid Uterus, Hysterectomy
- How many people
- 293 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 15 Oct 2025
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who were planned to undergo abdominal myomectomy in the past 4 years
Who may be able to join
- Women planned for abdominal myomectomy in the previous 4 years.
- Availability of complete medical records for pre-, intra- and post-operative data.
Who cannot join
- Missing or lacking information in the patients records like preoperative assessment of the fibroid uterus.
- Absence of operative notes and relevant data in the medical files.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Risk of Hysterectomy at Time of Myomectomy at Ain Shams University Hospital: A Retrospective Cohort Study.
Uterine fibroids are the commonest tumor affecting the female reproductive tract and many instances they are asymptomatic but in some women there does appear to be an association with heavy menstrual blood loss and possibly subfertility. Classically, treatment has been surgical with hysterectomy the most common approach for women who have completed their fertility and myomectomy for those who wish to conceive. The surgery can be carried out laparoscopically, vaginally and abdominally. The aim of this study is to evaluate the risk of hysterectomy at the time of myomectomy, and the associated 30-day postoperative morbidity.
- Conditions
- Myomectomy, Fibroid Uterus, Hysterectomy
- Keywords
- hysterectomy, myomectomy, fibroid uterus
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient who were planned for abdomoinal myomectomy | A retrospective study on women who were candidates for abdominal myomectomy in the previous 4 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hysterectomy at time of myomectomy.
Measured: Jan 2020- Dec 2024
Secondary outcomes (6)
Characteristics of the Myomas who required hysterectomy
number, site, size, Figo staging
Measured: Jan 2020- Dec 2024
Intraoperative complications
Anesthesia complication, organ injury, blood transfusion.
Measured: Jan 2020- Dec 2024
Postoperative complications
Anemia, hemorrhage, fever, wound infection, wound hematoma
Measured: Jan 2020- Dec 2024
Duration of hospital stay
in days
Measured: Jan 2020- Dec 2024
Reoperation
within 5 days of surgery
Measured: Jan 2020- Dec 2024
Readmission after discharge from the hospital
within 14 days
Measured: Jan 2020- Dec 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Dec 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Abdelrazek, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365969
- Sponsor's protocol ID
- FMASU MS 778/2024
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Hysterectomy at Time of Myomectomy at Ain Shams University Hospital: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07365969
- Acronym / sponsor ID
- FMASU MS 778/2024
- Conditions
- Myomectomy, Fibroid Uterus, Hysterectomy
- Keywords
- hysterectomy, myomectomy, fibroid uterus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 26 Jan 2026 (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.
Uterine fibroids are the commonest tumor affecting the female reproductive tract and many instances they are asymptomatic but in some women there does appear to be an association with heavy menstrual blood loss and possibly subfertility. Classically, treatment has been surgical with hysterectomy the most common approach for women who have completed their fertility and myomectomy for those who wish to conceive. The surgery can be carried out laparoscopically, vaginally and abdominally. The aim of this study is to evaluate the risk of hysterectomy at the time of myomectomy, and the associated 30-day postoperative morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who were planned for abdomoinal myomectomy | – | –A retrospective study on women who were candidates for abdominal myomectomy in the previous 4 years |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who were planned to undergo abdominal myomectomy in the past 4 years
Key inclusion criteria (2 listed)
- Women planned for abdominal myomectomy in the previous 4 years.
- Availability of complete medical records for pre-, intra- and post-operative data.
Key exclusion criteria (2 listed)
- Missing or lacking information in the patients records like preoperative assessment of the fibroid uterus.
- Absence of operative notes and relevant data in the medical files.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hysterectomy at time of myomectomy.
Time frame: Jan 2020- Dec 2024
6 secondary outcomes
Characteristics of the Myomas who required hysterectomy
Time frame: Jan 2020- Dec 2024
Intraoperative complications
Time frame: Jan 2020- Dec 2024
Postoperative complications
Time frame: Jan 2020- Dec 2024
Duration of hospital stay
Time frame: Jan 2020- Dec 2024
Reoperation
Time frame: Jan 2020- Dec 2024
Readmission after discharge from the hospital
Time frame: Jan 2020- Dec 2024
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 30 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myomectomy and Fibroid Uterus, run by Ain Shams University 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 2 inclusion and 2 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 30 Jan 2026. 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?
Incidence of hysterectomy at time of myomectomy. (time frame: Jan 2020- Dec 2024). 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 30 Jan 2026.