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
To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using myoma screw from abdominal approach in manipulation Instead of traditional uterine mani Pulator
Procedure: Total laparoscopic hysterectomy
Using traditional uterine manipulator via vagina in uterine manipulation
Procedure: Total laparoscopic hysterectomy
Hysterectomy by laparoscope using uterine manipulator or myoma screw as a manipulator of large uterus
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
Volume of blood loss in ml liters
Volume of blood loss in ml liters
Time frame: Day 1
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.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.