Clinical Outcomes of Robotic Myomectomy | NCT06208891

Studies
Clinical Outcomes of Robotic Myomectomy

NCT06208891

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Jan 17, 2024Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Women With Uterine Myoma

Interventions

Robotic 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

Dec 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

Nov 21, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 5, 2023

First Submission Date that Met QC Criteria

Jan 5, 2024

First Posted Date

Jan 17, 2024Actual

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

Jan 5, 2024

Last Update Posted Date

Jan 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & 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

To identify the predictors of perioperative outcomes in women who receive robotic myomectomy

Detailed Description

Uterine myoma is the most common gynecological tumor. Current surgical management was inclusive of conventional abdominal myomectomy, laparoscopy-assisted myomectomy, robotic-assisted myomectomy. The aim of this study was to identify the predictors of perioperative outcomes in women who receive robotic myomectomy

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic myomectomy		Women who received robotic myomectomy	Procedure: Robotic myomectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic myomectomy	Procedure	Robotic assisted laparoscopic myomectomy	Robotic myomectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical time	Factors (e.g., the location and largest diameter of the uterine myoma) predicting surgical time	1 week

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative blood loss	Factors (e.g., the location and largest diameter of the uterine myoma) predicting intraoperative blood loss	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

>20 years old women
women who received robotic myomectomy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women who received robotic myomectomy

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women who received robotic-assisted 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