ClinicalTrials.gg
Not yet recruitingNCT06976905Updated May 16, 2025

Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy

An interventional study of Total laparoscopic hysterectomy in Total Laparoscopic Hysterectomy With Myoma Screw, sponsored by Kafrelsheikh University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Total Laparoscopic Hysterectomy With Myoma Screw

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03

In context

Myoma

61 studies on the registry are indexed under Myoma; 10 are open to participants now.

This study's planned enrollment of 34 is below the median of 80 across 45 interventional studies indexed under Myoma.

Browse Myoma studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 30-60
  2. 25-40
  3. Large uterus with fundal level 12-24w diagnosed by TAS( Transabdominal Ultrasound)/TVUS(Transvaginal ultrasound)
  4. Adenomyosis

Exclusion criteria

Exclusion Criteria:

  1. more than 40
  2. patients with for laparscopic surgery e.g cardiac and cirrhotic patients
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Myoma screw usage in total laparoscopic hysterectomy in large uterus

    Using myoma screw from abdominal approach in manipulation Instead of traditional uterine mani Pulator

    Procedure: Total laparoscopic hysterectomy

  • Experimental
    Uterine manipulator in total laparoscopic hysterectomy in large uterus

    Using traditional uterine manipulator via vagina in uterine manipulation

    Procedure: Total laparoscopic hysterectomy

Interventions

  • ProcedureTotal laparoscopic hysterectomy

    Hysterectomy by laparoscope using uterine manipulator or myoma screw as a manipulator of large uterus

06

What researchers measure

Primary outcomes

  1. Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hours

    Using myoma screw as a manipulator in total laparoscopic hysterectomy

    Time frame: During surgery in hours

Secondary outcomes

  1. Volume of blood loss in ml liters

    Volume of blood loss in ml liters

    Time frame: Day 1

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for May 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2025
First posted
May 16, 2025
StartEst.
May 2025
Primary completionEst.
May 2025
CompletionEst.
Jun 2025
Last update
May 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06976905
Responsible party
Mona Gamil (Resident, Kafrelsheikh University) — Principal investigator
First posted
May 16, 2025
Start date
May 2025 (estimated)
Primary completion
May 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
May 16, 2025

Study contacts

Mona Gamil, Resident
Contact
gamilmona418@gmail.com
+2001095449403 ext. +2001020256670
Ahmed Fathy, MD
Contact
+2001221485021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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