Comparison of Perioperative Outcome Between Monopolar and... | NCT05423925

Studies
Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy

NCT05423925

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Jul 10, 2023Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Hysteroscopic Myomectomy

Interventions

Bipolar hysteroscopic myomectomy
Monopolar hysteroscopic myomectomy

Countries

Taiwan

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 14, 2022

First Submission Date that Met QC Criteria

Jun 14, 2022

First Posted Date

Jun 21, 2022Actual

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

Jul 6, 2023

Last Update Posted Date

Jul 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief of Department of Obstetrics and Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bipolar hysteroscopic myomectomy	Procedure	Bipolar hysteroscopic myomectomy.	bipolar

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

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

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

> 20 years old women who received hysteroscopic myomectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Recruiting	Banqiao District	New Taipei	22050	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided