Comparison of Robot-assisted Laparoscopic Myomectomy and... | NCT03250221

Studies
Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures

NCT03250221

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Feb 12, 2019Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Myomectomy

Interventions

barbed sutures
Vicryl@ suture

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2017Actual

Primary Completion Date

Nov 1, 2017Actual

Completion Date

Nov 1, 2017Actual

First Submitted Date

Aug 10, 2017

First Submission Date that Met QC Criteria

Aug 14, 2017

First Posted Date

Aug 15, 2017Actual

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

Feb 9, 2019

Last Update Posted Date

Feb 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, 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 elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy

Detailed Description

The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic myomectomy and laparoscopic 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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic or laparoscopic myomectomy		Women who received robotic or laparoscopic myomectomy	Device: barbed sutures Device: Vicryl@ suture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
barbed sutures	Device	Use of the barbed sutures for robotic or laparoscopic myomectomy	Robotic or laparoscopic myomectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal drainage amount	Postoperative day 1 abdominal drainage amount	1 day

Secondary Outcomes

Measure	Description	Time Frame
Blood loss	Blood loss during surgeries	1 day
Surgical time	Surgical time	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women who underwent robotic myomectomy and conventional laparoscopic myomectomy in the Department of Obstetrics & Gynecology of Far Eastern Memorial Hospital.

Exclusion Criteria:

Open myomectomy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women who underwent robotic myomectomy and conventional laparoscopic myomectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sheng-Mou Hsiao, MD	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23379670	Background	Hsiao SM, Lin HH, Peng FS, Jen PJ, Hsiao CF, Tu FC. Comparison of robot-assisted laparoscopic myomectomy and traditional laparoscopic myomectomy. J Obstet Gynaecol Res. 2013 May;39(5):1024-9. doi: 10.1111/j.1447-0756.2012.02073.x. Epub 2013 Feb 4.