Sponsor study identifier
interventional
100
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 12, 2010
Actual (reported)January 14, 2010
Actual (reported)October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
1 year
To evaluate the cosmetic outcome.
1 year
single port LAVH
single-port LAVH
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Veterans General Hospital -Taipei
Taipei, 11217, Taiwan
Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.
Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):906-912. doi: 10.1097/AOG.0b013e31820c666a.
Yi-Jen Chen, MD
Taipei Veterans General Hospital, Taiwan
First Submitted
January 12, 2010
First Posted
January 14, 2010
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Estimated (date passed)Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI in Adenomyosis
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2010
Record last verified: 2010-01
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Source: ClinicalTrials.gov.
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