Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05423925
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 11.8
• Patients Per Site Per Month: 21.3

Study Details

Study Description

Brief Summary

Objective:

To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.

Condition or Disease	Intervention/Treatment	Phase
Hysteroscopic Myomectomy	Procedure: Bipolar hysteroscopic myomectomy; Procedure: Monopolar 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: We can get the differences between monopolar and bipolar hysteroscopic myomectomy, and the result can be used as a reference in clinical practice.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy.
• Actual Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Infused volume of distension medium [3 months]

   The differences of infused volume of distension medium

Secondary Outcome Measures

1. Operation time [3 months]

   The between-group difference in operation time

2. Pain score after the procedure [3 months]

   The between-group difference in pain score after the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Mou Hsiao, Chief of Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05423925
• Other Study ID Numbers: 111121-E
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 21, 2022