NCT05423925

Brief Summary

Objective: To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

June 7, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

June 14, 2022

Last Update Submit

July 6, 2023

Conditions

Hysteroscopic Myomectomy

Outcome Measures

Primary Outcomes (1)

  • Infused volume of distension medium

    The differences of infused volume of distension medium

    3 months

Secondary Outcomes (2)

  • Operation time

    3 months

  • Pain score after the procedure

    3 months

Study Arms (2)

monopolar

monopolar electrodes, and have their corresponding distension media.

Procedure: Monopolar hysteroscopic myomectomy

bipolar

bipolar electrodes, and have their corresponding distension media.

Procedure: Bipolar hysteroscopic myomectomy

Interventions

Bipolar hysteroscopic myomectomyPROCEDURE

Bipolar hysteroscopic myomectomy.

bipolar
Monopolar hysteroscopic myomectomyPROCEDURE

Monopolar hysteroscopic myomectomy

monopolar

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\> 20 years old women who received hysteroscopic myomectomy

You may qualify if:

  • women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.

You may not qualify if:

  • \< 20 years old women
  • Cervical fibroids were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Study Start

June 7, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)