Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
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. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery
demonstrate that the techniques are feasible provided that both optimal surgical technical
expertise with advanced skills and optimal instrumentation are available. Recently, Lee et
al. performed the multiple channel single port-access laparoscopic-assisted vaginal
hysterectomy (SPA-LAVH) in 24 patient. All cases but 3 were performed exclusively through a
single port. The median operative time, weight of the uterus, and estimated blood loss were
119 minutes (range 90 to 255 minutes), 347 g (range 225 to 732 g), and 400 mL (range 100 to
1000 mL), respectively. The median hospital stay (postoperative day) was 3 days (range 3 to
7). Although there are a limited number of studies demonstrating the feasibility of
single-port access laparoscopic-assisted vaginal hysterectomy (LAVH), single-port surgery is
"new-old" (i.e., a revisited and unstandardized technique) because the major disadvantage of
limited movement caused by collisions of the laparoscopic instruments has been mitigated by
the development of multi-channel approaches. Therefore, the investigators used a 2-channel
single-port system, which was different from the previously published 3-channel single-port
technique11,12 to reduce collisions and aid the assistant in controlling the scope without
interfering with the surgeon's instruments. To our knowledge, there are no randomize
control trial to evaluate of 2-channel or multiple channel single port laparoscopic surgery
in gynecologic disorders. The purpose of this study was to assess the feasibility of
2-channel and multiple-channel single port laparoscopy in the treatment of benign uterine
disease.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
The operative time
We will follow the patients until one month after the surgery. The primary outcome measure of this trial is the effect and safety of single port-access laparoscopic-assisted vaginal hysterectomy.
We will follow the patients until one month after the surgery.
Yes
Yi-Jen Chen, PHD
Study Director
Taipei Veterans General Hospital,Taiwan
Taiwan: Institutional Review Board
VGH2011-03-011IA
NCT01564602
January 2011
December 2014
Name | Location |
---|