Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy

July 6, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Objective:

To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Methods:

Hysteoscopic myomectomy is a safe and effective procedure to remove submucosal myoma. Distension media is needed to distend the uterine cavity during the procedure. The electric cutting loops included monopolar and bipolar electrodes, and have their corresponding distension media. Medical records, including outpatient and inpatient records, operation note, and laboratory data, of all consecutive women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.

Expected result: The investigatorscan get the differences between monopolar and bipolar hysteroscopic myomectomy, and the result can be used as a reference in clinical practice.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Recruiting
        • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

> 20 years old women who received hysteroscopic myomectomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
monopolar
monopolar electrodes, and have their corresponding distension media.
Procedure: Monopolar hysteroscopic myomectomy
Monopolar hysteroscopic myomectomy
bipolar
bipolar electrodes, and have their corresponding distension media.
Procedure: Bipolar hysteroscopic myomectomy
Bipolar hysteroscopic myomectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infused volume of distension medium
Time Frame: 3 months
The differences of infused volume of distension medium
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: 3 months
The between-group difference in operation time
3 months
Pain score after the procedure
Time Frame: 3 months
The between-group difference in pain score after the procedure Pain score:0-10, the minimun values mean a better
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 111121-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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