Skip to content

Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy

Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06976905
Enrollment
34
Registered
2025-05-16
Start date
2025-05-31
Completion date
2025-06-30
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Laparoscopic Hysterectomy With Myoma Screw

Brief summary

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.

Interventions

PROCEDURETotal laparoscopic hysterectomy

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

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

1 group using uterine manipulator vs another group using myoma screw

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

1. BMI more than 40 2. patients with contraindication for laparscopic surgery e.g cardiac and cirrhotic patients

Design outcomes

Primary

MeasureTime frameDescription
Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hoursDuring surgery in hoursUsing myoma screw as a manipulator in total laparoscopic hysterectomy

Secondary

MeasureTime frameDescription
Volume of blood loss in ml litersDay 1Volume of blood loss in ml liters

Countries

Egypt

Contacts

Primary ContactMona Gamil, Resident
gamilmona418@gmail.com+2001095449403
Backup ContactAhmed Fathy, MD
+2001221485021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026