Risk of Hysterectomy at Time of Myomectomy | NCT07365969

Studies
Risk of Hysterectomy at Time of Myomectomy

NCT07365969

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 30, 2026Actual

Enrollment

293Actual

Phase

Not provided

Conditions

Myomectomy
Fibroid Uterus
Hysterectomy

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2024Actual

Primary Completion Date

Oct 15, 2025Actual

Completion Date

Oct 15, 2025Actual

First Submitted Date

Jan 17, 2026

First Submission Date that Met QC Criteria

Jan 17, 2026

First Posted Date

Jan 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

293Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient who were planned for abdomoinal myomectomy		A retrospective study on women who were candidates for abdominal myomectomy in the previous 4 years

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of hysterectomy at time of myomectomy.		Jan 2020- Dec 2024

Secondary Outcomes

Measure	Description	Time Frame
Characteristics of the Myomas who required hysterectomy	number, site, size, Figo staging	Jan 2020- Dec 2024
Intraoperative complications	Anesthesia complication, organ injury, blood transfusion.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women who were planned for abdominal myomectomy

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Ain Shams University		Cairo		11591	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided