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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
  Purpose

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.


Condition
Uterine Myoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Uterine Fibroids
U.S. FDA Resources

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • amount of postoperation abdominal drainage [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • operation time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • blood loss [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
uterine myoma

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • cases with uterine myoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542658

Locations
Taiwan
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao, New Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01542658     History of Changes
Other Study ID Numbers: 100167-E
Study First Received: February 26, 2012
Last Updated: March 1, 2012
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013