Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sheng-Mou Hsiao, Far Eastern Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01542658

First received: February 26, 2012

Last updated: March 1, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 26, 2012
Last Updated Date	March 1, 2012
Start Date ^ICMJE	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 1, 2012)	amount of postoperation abdominal drainage [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01542658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 1, 2012)	operation time [ Time Frame: 1 day ] [ Designated as safety issue: No ] blood loss [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy
Official Title ^ICMJE	Not Provided
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with uterine myoma, and underwent primary treatment (RALM and TLM) in Far Eastern Memorial Hospital
Condition ^ICMJE	Uterine Myoma
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	uterine myoma
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: cases with uterine myoma
Gender	Female
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT01542658
Other Study ID Numbers ^ICMJE	100167-E
Has Data Monitoring Committee	No
Responsible Party	Sheng-Mou Hsiao, Far Eastern Memorial Hospital
Study Sponsor ^ICMJE	Far Eastern Memorial Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Far Eastern Memorial Hospital
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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