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Single-port Access Laparoscopic-assisted Vaginal Hysterectomy

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ClinicalTrials.gov Identifier: NCT01048931
Recruitment Status : Unknown
Verified January 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : January 14, 2010
Last Update Posted : January 14, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Minimally invasive surgery has become the standard treatment for many gynecologic disease processes. In the last decade, numerous studies have demonstrated that laparoscopic approaches to various gynecologic oncology conditions-particularly for early-stage endometrial and cervical cancers as well as select pelvic masses-is feasible and results in shorter hospital stays, improved quality of life and comparable surgical and oncologic outcomes to abdominal staging [1-5].For instance, the typical gynecologic robotic surgical procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an even less invasive alternative to conventional laparoscopy surgery has been developed: laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. However, to our knowledge, there are no randomize control trial to evaluate of single port or multiple ports laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of SPA-LAVH in the treatment of benign uterine disease.

Condition or disease Intervention/treatment Phase
Uterine Myomas Adenomyosis Procedure: single-port LAVH Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare to Single-port Access Laparoscopic-assisted Vaginal Hysterectomy (LAVH) and Multiple Ports LAVH: A Randomized Controlled Trial
Study Start Date : October 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: single-port LAVH
single port LAVH
Procedure: single-port LAVH
single-port LAVH


Outcome Measures

Primary Outcome Measures :
  1. To assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The pain score and morbidity associated with surgery will be noted. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To evaluate the cosmetic outcome. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
  • American Society of Anesthesiologists (ASA) physical status of patient: classification I-II

Exclusion Criteria:

  • The procedure will be required to conversion to laparotomy.
  • Cancer
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048931


Contacts
Contact: Yi-Jen Chen, MD 886-2-28757566 chenyj@vghtpe.gov.tw

Locations
Taiwan
Veterans General Hospital -Taipei Recruiting
Taipei, Taiwan, 11217
Contact: Yi-Jen Chen, MD    886-2-28757566    chenyj@vghtpe.gov.tw   
Principal Investigator: Yi-Jen Chen, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Yang Ming University
Investigators
Study Chair: Yi-Jen Chen, MD Taipei Veterans General Hospital, Taiwan
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chen-Hsen Lee, MD, Chairman, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01048931     History of Changes
Other Study ID Numbers: VGHIRB 98-10-03
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Single-port, laparoscopic-assisted, vaginal hysterectomy

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female
Connective Tissue Diseases
Adenomyosis
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue