Total Laparoscopic Hysterectomy With Myoma ScrewNCT06976905
Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy
A study testing Total laparoscopic hysterectomy in people with Total Laparoscopic Hysterectomy With Myoma Screw, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Total Laparoscopic Hysterectomy With Myoma Screw
- What is being tested?
- Total laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- May 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30-60
- BMI 25-40
- Large uterus with fundal level 12-24w diagnosed by TAS( Transabdominal Ultrasound)/TVUS(Transvaginal ultrasound)
- Adenomyosis
Who cannot join
- BMI more than 40
- patients with contraindication for laparscopic surgery e.g cardiac and cirrhotic patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Fathy, MD contact
About this study
To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy
Read the detailed description
Hysterectomy is performed on 1,500,000 women worldwide each year to treat benign disorders such leiomyoma, prolapse, and irregular bleeding, as well as gynecologic malignancies. Prior to the introduction of the first laparoscopic procedures in the late 1980s, hysterectomy was traditionally accomplished by laparotomy or the vaginal route. Total laparoscopic hysterectomy (TLH) became the most commonly used hysterectomy technique in the last ten years, especially in developed nations, because laparoscopic hysterectomy has some advantages over other hysterectomy types, including high patient satisfaction, an earlier return to work, less blood loss, the ability to diagnose and treat other pelvic diseases, and the ability to maintain thorough intraperitoneal haemostasis.
However, there are some drawbacks to TLH as well, such as its expensive cost, lengthier operating time, and requirement for advanced technological instruments including uterine manipulators (UM) and sealing devices.
In order to facilitate colpotomy by defining the cervicovaginal junction and enable safer dissection around the cervix, the main goal of utilising a UM is to extend the distance between the cervix and ureter.There isn't enough clinical data in the literature to say whether using UM meets these expectations, though.Additionally, the use of UMs has been linked to a number of specific problems, such as uterine rupture, intestinal perforation, and vaginal wall laceration.UMs are also not appropriate in certain cases, such as vaginal stenosis, anatomical differences that make it difficult to identify the uterus or cervix, and patients who refuse vaginal penetration because they are virgins. There is still no "optimal UM" that is consistently safe, effective, and economical, despite the fact that numerous UMs have been developed in recent decades.
Some studies have suggested alternatives including the use of certain sutures, gripping forceps, or myoma screws (MS) as answers to the issues that arise with the use of UM. When performing a myomectomy using the vaginal method, laparotomy, or laparoscopy, the MS is a conventional, reusable instrument. MSs are renowned for their ability to deliver a powerful three-dimensional traction force. Additionally, using MS does not require specialised knowledge like UMs do.
- Being tested
- Total laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laparoscopic hysterectomyProcedure or surgery
Hysterectomy by laparoscope using uterine manipulator or myoma screw as a manipulator of large uterus
| Study group | Role | What they receive |
|---|---|---|
| Myoma screw usage in total laparoscopic hysterectomy in large uterus | Experimental | Using myoma screw from abdominal approach in manipulation Instead of traditional uterine mani Pulator Receives: Procedure: Total laparoscopic hysterectomy |
| Uterine manipulator in total laparoscopic hysterectomy in large uterus | Experimental | Using traditional uterine manipulator via vagina in uterine manipulation Receives: Procedure: Total laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hours
Using myoma screw as a manipulator in total laparoscopic hysterectomy
Measured: During surgery in hours
Secondary outcomes (1)
Volume of blood loss in ml liters
Volume of blood loss in ml liters
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic Hysterectomy With Myoma ScrewStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 group using uterine manipulator vs another group using myoma screw
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gamil, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976905
- Sponsor's protocol ID
- KFSIRB200-545
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06976905
- Acronym / sponsor ID
- KFSIRB200-545
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 May 2025 (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.
To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy
Detailed description
Hysterectomy is performed on 1,500,000 women worldwide each year to treat benign disorders such leiomyoma, prolapse, and irregular bleeding, as well as gynecologic malignancies. Prior to the introduction of the first laparoscopic procedures in the late 1980s, hysterectomy was traditionally accomplished by laparotomy or the vaginal route. Total laparoscopic hysterectomy (TLH) became the most commonly used hysterectomy technique in the last ten years, especially in developed nations, because laparoscopic hysterectomy has some advantages over other hysterectomy types, including high patient satisfaction, an earlier return to work, less blood loss, the ability to diagnose and treat other pelvic diseases, and the ability to maintain thorough intraperitoneal haemostasis.
However, there are some drawbacks to TLH as well, such as its expensive cost, lengthier operating time, and requirement for advanced technological instruments including uterine manipulators (UM) and sealing devices.
In order to facilitate colpotomy by defining the cervicovaginal junction and enable safer dissection around the cervix, the main goal of utilising a UM is to extend the distance between the cervix and ureter.There isn't enough clinical data in the literature to say whether using UM meets these expectations, though.Additionally, the use of UMs has been linked to a number of specific problems, such as uterine rupture, intestinal perforation, and vaginal wall laceration.UMs are also not appropriate in certain cases, such as vaginal stenosis, anatomical differences that make it difficult to identify the uterus or cervix, and patients who refuse vaginal penetration because they are virgins. There is still no "optimal UM" that is consistently safe, effective, and economical, despite the fact that numerous UMs have been developed in recent decades.
Some studies have suggested alternatives including the use of certain sutures, gripping forceps, or myoma screws (MS) as answers to the issues that arise with the use of UM. When performing a myomectomy using the vaginal method, laparotomy, or laparoscopy, the MS is a conventional, reusable instrument. MSs are renowned for their ability to deliver a powerful three-dimensional traction force. Additionally, using MS does not require specialised knowledge like UMs do.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1 group using uterine manipulator vs another group using myoma screw
| Arm | Type | Receives |
|---|---|---|
| Myoma screw usage in total laparoscopic hysterectomy in large uterus | Experimental | Procedure: Total laparoscopic hysterectomyUsing myoma screw from abdominal approach in manipulation Instead of traditional uterine mani Pulator |
| Uterine manipulator in total laparoscopic hysterectomy in large uterus | Experimental | Procedure: Total laparoscopic hysterectomyUsing traditional uterine manipulator via vagina in uterine manipulation |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 30-60
- BMI 25-40
- Large uterus with fundal level 12-24w diagnosed by TAS( Transabdominal Ultrasound)/TVUS(Transvaginal ultrasound)
- Adenomyosis
Key exclusion criteria (2 listed)
- BMI more than 40
- patients with contraindication for laparscopic surgery e.g cardiac and cirrhotic patients
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 |
|---|---|---|
| Total laparoscopic hysterectomyHysterectomy by laparoscope using uterine manipulator or myoma screw as a manipulator of large uterus | Procedure or surgery | Myoma screw usage in total laparoscopic hysterectomy in large uterus, Uterine manipulator in total laparoscopic hysterectomy in large uterus |
Primary outcome
Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hours
Time frame: During surgery in hours
Using myoma screw as a manipulator in total laparoscopic hysterectomy
1 secondary outcome
Volume of blood loss in ml liters
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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.
Ahmed Fathy, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total laparoscopic hysterectomy in people with Total Laparoscopic Hysterectomy With Myoma Screw, run by Kafrelsheikh 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 4 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: opening soon, as of the sponsor's last update on 16 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Gamil, Resident (+2001095449403 ext. +2001020256670, gamilmona418@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hours (time frame: During surgery in hours). 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 16 May 2025.