Comparison of Robot-assisted Laparoscopic Myomectomy With... | NCT01542658

Studies
Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy

NCT01542658

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Mar 2, 2012Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Uterine Myoma

Interventions

Not provided

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 2012

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

Feb 2012

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Feb 26, 2012

First Submission Date that Met QC Criteria

Mar 1, 2012

First Posted Date

Mar 2, 2012Estimated

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

Mar 1, 2012

Last Update Posted Date

Mar 2, 2012Estimated

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)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative variables and short-term outcome of RALM and TLM patients.

Detailed Description

All patients with symptomatic uterine myomas who underwent traditional laparoscopic myomectomy or robotic laparoscopic myomectomy were enrolled.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

42Actual

Label	Type	Description	Intervention Names
uterine myoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amount of postoperation abdominal drainage		5 days

Secondary Outcomes

Measure	Description	Time Frame
operation time		1 day
blood loss		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cases with uterine myoma

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

Patients with uterine myoma, and underwent primary treatment (RALM and TLM) in Far Eastern Memorial Hospital

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		Banqiao District	New Taipei	22050	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D047708	Myofibroma

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided