NCT07365969

Brief Summary

Uterine fibroids are the commonest tumor affecting the female reproductive tract and many instances they are asymptomatic but in some women there does appear to be an association with heavy menstrual blood loss and possibly subfertility. Classically, treatment has been surgical with hysterectomy the most common approach for women who have completed their fertility and myomectomy for those who wish to conceive. The surgery can be carried out laparoscopically, vaginally and abdominally. The aim of this study is to evaluate the risk of hysterectomy at the time of myomectomy, and the associated 30-day postoperative morbidity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 17, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

hysterectomymyomectomyfibroid uterus

Outcome Measures

Primary Outcomes (1)

  • Incidence of hysterectomy at time of myomectomy.

    Jan 2020- Dec 2024

Secondary Outcomes (6)

  • Characteristics of the Myomas who required hysterectomy

    Jan 2020- Dec 2024

  • Intraoperative complications

    Jan 2020- Dec 2024

  • Postoperative complications

    Jan 2020- Dec 2024

  • Duration of hospital stay

    Jan 2020- Dec 2024

  • Reoperation

    Jan 2020- Dec 2024

  • +1 more secondary outcomes

Study Arms (1)

Patient who were planned for abdomoinal myomectomy

A retrospective study on women who were candidates for abdominal myomectomy in the previous 4 years

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who were planned for abdominal myomectomy
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women who were planned to undergo abdominal myomectomy in the past 4 years

You may qualify if:

  • Women planned for abdominal myomectomy in the previous 4 years.
  • Availability of complete medical records for pre-, intra- and post-operative data.

You may not qualify if:

  • Missing or lacking information in the patients records like preoperative assessment of the fibroid uterus.
  • Absence of operative notes and relevant data in the medical files.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

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

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

December 15, 2024

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations