Different Methods to Minimize Blood Loss During Laparoscopic MyomectomyNCT06566352
Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial
A study testing Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine, traditional laparoscopic myomectomy and laparoscopic myomectomy with temporary bilateral uterine artery occlusion in people with Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy, run by Zagazig University at 1 site in Egypt.
Trial summary
Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy
- What is being tested?
- Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine, traditional laparoscopic myomectomy and laparoscopic myomectomy with temporary bilateral uterine artery occlusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2025
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged from 18 to 39 years.
- Symptomatizing Women (heavy menstrual bleeding or subfertility).
- FIGO stage (3-7) by ultrasound.
- Only uterine corpus fibroid.
- Up to three fibroids by ultrasound.
- No previous hormonal treatment.
Who cannot join
- Patients with bleeding tendency.
- Patients who refuse to participate in the study or uncooperative patients.
- Current pregnancy.
- Any retroperitoneal surgery at pararectal space.
- More than one cesarean delivery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, 7123001
Mohamed s ali, MD, 01282112344, alimo987@gmail.com
About this study
Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.
Read the detailed description
Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation, and hospitalization period after laparoscopic myomectomy.
This will be the first study to investigate the efficacy of Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine in minimizing blood loss during Laparoscopic myomectomy at our university.
Can Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine give better outcomes regarding intraoperative bleeding when compared to traditional laparoscopic myomectomy?
- Being tested
- Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine, traditional laparoscopic myomectomy, laparoscopic myomectomy with temporary bilateral uterine artery occlusion, injection of epinephrine 1mg diluted in 200mg of NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic myomectomy with intramyometrial injection of diluted epinephrineProcedure or surgery
intramyometrial injection of epinephrine 1mg diluted in 200mg of NaCl solution
traditional laparoscopic myomectomyProcedure or surgery
traditional laparoscopic myomectomy
laparoscopic myomectomy with temporary bilateral uterine artery occlusionProcedure or surgery
Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion
injection of epinephrine 1mg diluted in 200mg of NaClDrug
injection of epinephrine 1mg diluted in 200mg of NaCl
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic myomectomy with temporary bilateral uterine artery occlusion | Experimental | laparoscopic myomectomy with temporary bilateral uterine artery occlusion Receives: Procedure: laparoscopic myomectomy with temporary bilateral uterine artery occlusion |
| Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine | Experimental | Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine Receives: Procedure: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine; Drug: injection of epinephrine 1mg diluted in 200mg of NaCl |
| traditional laparoscopic myomectomy | Experimental | traditional laparoscopic myomectomy Receives: Procedure: traditional laparoscopic myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
estimated blood loss
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Different Methods to Minimize Blood Loss During Laparoscopic MyomectomyStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Nashat Fatah Allah Omran, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566352
- Sponsor's protocol ID
- 218/12-3-2024
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06566352
- Acronym / sponsor ID
- 218/12-3-2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.
Detailed description
Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation, and hospitalization period after laparoscopic myomectomy.
This will be the first study to investigate the efficacy of Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine in minimizing blood loss during Laparoscopic myomectomy at our university.
Can Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine give better outcomes regarding intraoperative bleeding when compared to traditional laparoscopic myomectomy?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laparoscopic myomectomy with temporary bilateral uterine artery occlusion | Experimental | Procedure: laparoscopic myomectomy with temporary bilateral uterine artery occlusionlaparoscopic myomectomy with temporary bilateral uterine artery occlusion |
| Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine | Experimental | Procedure: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine, Drug: injection of epinephrine 1mg diluted in 200mg of NaClLaparoscopic myomectomy with intramyometrial injection of diluted epinephrine |
| traditional laparoscopic myomectomy | Experimental | Procedure: traditional laparoscopic myomectomytraditional laparoscopic myomectomy |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged from 18 to 39 years.
- Symptomatizing Women (heavy menstrual bleeding or subfertility).
- FIGO stage (3-7) by ultrasound.
- Only uterine corpus fibroid.
- Up to three fibroids by ultrasound.
Key exclusion criteria (5 listed)
- Patients with bleeding tendency.
- Patients who refuse to participate in the study or uncooperative patients.
- Current pregnancy.
- Any retroperitoneal surgery at pararectal space.
- More than one cesarean delivery.
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 |
|---|---|---|
| Laparoscopic myomectomy with intramyometrial injection of diluted epinephrineintramyometrial injection of epinephrine 1mg diluted in 200mg of NaCl solution | Procedure or surgery | Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine |
| traditional laparoscopic myomectomytraditional laparoscopic myomectomy | Procedure or surgery | traditional laparoscopic myomectomy |
| laparoscopic myomectomy with temporary bilateral uterine artery occlusionExperimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion | Procedure or surgery | laparoscopic myomectomy with temporary bilateral uterine artery occlusion |
| injection of epinephrine 1mg diluted in 200mg of NaClinjection of epinephrine 1mg diluted in 200mg of NaCl | Drug | Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine |
Primary outcome
blood loss
Time frame: intra-operative
estimated blood loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine, traditional laparoscopic myomectomy and laparoscopic myomectomy with temporary bilateral uterine artery occlusion in people with Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy, run by Zagazig 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: intra-operative). 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 22 Aug 2024.