NCT07578246

Brief Summary

This study aims to evaluate the applicability of the LASMAR scoring system, derived from hysteroscopy, in predicting surgical outcomes in patients undergoing hysteroscopic myomectomy for submucous fibroids.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Jul 2028

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between preoperative parameters assessed using the Lasmar score and operative parameters, including operative time, number of sessions needed for complete resection, fluid deficit and intraoperative complications.

    Correlation between preoperative parameters assessed using the Lasmar score and operative parameters, including operative time, number of sessions needed for complete resection, fluid deficit and intraoperative complications

    2 years

Secondary Outcomes (2)

  • Postoperative Complications: Including infection, adhesions, volume overload.

    2 years

  • Need for Further Interventions: Incidence of additional treatments like hormonal therapy

    2 years

Interventions

Hysteroscopic myomectomy is a minimally invasive surgical procedure used to remove fibroids that are located inside the uterine cavity (submucosal fibroids).

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing hysteroscopic myomectomy for symptomatic uterine fibroids.

You may qualify if:

  • Women aged 18-45 years
  • Type 0,1,2 Fibroids according to Figo classification.
  • Symptomatic submucous fibroids: Symptoms include abnormal uterine bleeding, pelvic pain or pressure symptoms, infertility or recurrent pregnancy loss.
  • Fibroids size ≤ 5 cm in diameter
  • Confirmed diagnosis of leiomyoma by ultrasound .
  • Hemodynamically Stable Patients: Patients with no significant anemia.

You may not qualify if:

  • Contraindications to hysteroscopy (e.g., Pregnancy, pyometra, active infection)
  • Individuals with significant comorbidities (e.g., severe cardiovascular or respiratory diseases, bleeding diathesis).
  • Cases requiring concurrent procedures (e.g., Laparoscopic surgeries).
  • Fibroid Size\>5 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yomna Ayman Salah, Master degree

CONTACT

Ahmed Mohammed Selim, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

May 11, 2026

Record last verified: 2026-05