Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy

Recruiting

• Conditions: Hysteroscopic Myomectomy
• Interventions: Procedure: Bipolar hysteroscopic myomectomy; Procedure: Monopolar hysteroscopic myomectomy

• Registration Number: NCT05423925
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

Objective:

To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.

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 Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bipolar	Bipolar hysteroscopic myomectomy	bipolar electrodes, and have their corresponding distension media.
monopolar	Monopolar hysteroscopic myomectomy	monopolar electrodes, and have their corresponding distension media.

Primary Outcome Measures

Name	Time	Method
Infused volume of distension medium	3 months	The differences of infused volume of distension medium

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan