NCT06976905

Brief Summary

To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 9, 2025

Last Update Submit

May 9, 2025

Conditions

Total Laparoscopic Hysterectomy With Myoma Screw

Outcome Measures

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

    During surgery in hours

Secondary Outcomes (1)

  • Volume of blood loss in ml liters

    Day 1

Study Arms (2)

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

Procedure: Total laparoscopic hysterectomy

Uterine manipulator in total laparoscopic hysterectomy in large uterus

EXPERIMENTAL

Using traditional uterine manipulator via vagina in uterine manipulation

Procedure: Total laparoscopic hysterectomy

Interventions

Total laparoscopic hysterectomyPROCEDURE

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

Myoma screw usage in total laparoscopic hysterectomy in large uterusUterine manipulator in total laparoscopic hysterectomy in large uterus

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Egypt

Location

Central Study Contacts

Mona Gamil, Resident

CONTACT

+2001095449403gamilmona418@gmail.com

Ahmed Fathy, MD

CONTACT

+2001221485021

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1 group using uterine manipulator vs another group using myoma screw
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 9, 2025

First Posted

May 16, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-04

Locations

EG(1)