NCT01542658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

Same day

First QC Date

February 26, 2012

Last Update Submit

March 1, 2012

Conditions

Uterine Myoma

Outcome Measures

Primary Outcomes (1)

  • amount of postoperation abdominal drainage

    5 days

Secondary Outcomes (2)

  • operation time

    1 day

  • blood loss

    1 day

Study Arms (1)

uterine myoma

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • cases with uterine myoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

TW(1)