Single-port Access Laparoscopic-assisted Vaginal Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Yang Ming University
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01048931
First received: January 12, 2010
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Uterine Myomas
Adenomyosis
Procedure: single-port LAVH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the cosmetic outcome. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single-port LAVH
single port LAVH
Procedure: single-port LAVH
single-port LAVH
Other Name: single-port LAVH

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: January 12, 2010
Last Updated: January 13, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on September 30, 2014