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The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC)compared to those undergoing the same procedure with the assistance of a robot.
Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. Thje investigators don't know if the decision to use robotic assistance at the time of laparoscopic sacrocolpopexy is a benefit for the patient. The investigators will compare the outcomes of cost, quality of life, and return to work for women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.
This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the investigators also will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.
Approximately one in ten women undergoes surgery for prolapse or incontinence in her lifetime. Of these, up to thirty percent require a re-operation for recurrence of their prolapse or incontinence symptoms. It has been estimated one in nine women will undergo a hysterectomy in her lifetime, and up to 10% of these women will require surgery for symptomatic vaginal vault prolapse. The search for the ideal repair for pelvic organ prolapse has led to the invention of several approaches to this problem.
Abdominal sacrocolpopexy (ASC) with synthetic mesh is considered the gold standard in the surgical management of pelvic organ prolapse with anatomic success rates ranging from 90 to 100% (Brubaker L, Guiahi M). Randomized comparative effectiveness trials and systematic literature reviews demonstrated the anatomic superiority of open ASC compared to vaginal sacrospinous ligament suspension.
Although ASC has the highest anatomic success rates for correcting apical prolapse, it is traditionally done via a laparotomy requiring an abdominal incision. Open technique is associated with more frequent short-term complications, including gastrointestinal (Benson JT, Whitehead W).
Minimally invasive approaches to ASC using laparoscopy or robotic assisted laparoscopy demonstrate shorter hospital stays, decreased blood loss, and similar short-term anatomic outcomes when compared to open ASC (Geller E, Tarr M, Paiso M). Increasing numbers of surgeons and patients choose minimally invasive ASC to maximize the benefits of abdominally placed mesh and the shorter-recovery associated with minimally invasive surgery. Few studies have compared laparoscopy to robotic assisted-laparoscopy in pelvic reconstructive surgery.
Like many techniques in pelvic surgery, trends in the management of pelvic organ prolapse continue to evolve. Unfortunately, such trends are not supported by level I data, specifically that provided by randomized clinical trials. Although robotic technology is new and rapidly spreading throughout the urologic and gynecologic communities, there are no randomized trials comparing outcomes of robotic to more traditional laparoscopic techniques for reconstructive pelvic surgery. Retrospective series indicate comparable efficacy with respect to cure of prolapse. However, to date is it unknown how robotic surgery compares to laparoscopic techniques with respect to cost, patient safety, pain, and ability to return to normal activities.
The use of the robot in laparoscopic surgery is costly. The costs of purchasing a robot has been estimated at $1.5 million dollars with annual maintenance costs of $112,0007. In addition, additional costs exist for the robotic equipment utilized with each case. It is arguable that the maintenance and operative equipment costs may overshadow any potential savings in length of hospital stay and patient convalescence. However, if robotic sacrocolpopexy can provide better immediate quality of life, less pain, and faster recovery compared to laparoscopic techniques, the investment in robotic techniques may very well be cost effective when a societal perspective is taken.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Pelvic Organ Prolapse
Robotic Assisted Laparoscopic ASC, Laparoscopic Abdominal Sacrocolpopexy
Published on BioPortfolio: 2014-08-27T03:13:39-0400
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.
Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic organ p...
This is a prospective, comparative randomized study. Our study population includes women with pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy. The two grou...
Based on a prospective study, to evaluate how pre-operative pelvic floor status - the presence of injury to the musculus levator ani - may influence the results of laparoscopic sacrocolpop...
To assess feasibility and postoperative outcomes associated with laparoscopic sacrocolpopexy in patients presenting with exteriorized pelvic organ prolapse (stage>3).
Though previous major abdominal surgery and pelvic irradiation may be a significant drawback of subsequent laparoscopic procedure, technological advances such as better visualization and more controll...
The objective of this study is to report our center's series of Robotic-Assisted Laparoscopic Abdominal Cerclage (RALAC) placement during pregnancy.
Most case series describing surgical repair for pelvic organ prolapse (POP) after radical cystectomy (RC) focus on transvaginal repairs. We present our experience of POP after RC repaired by abdominal...
Sacrocolpopexy has long been the preferred surgical procedure for the management of apical vaginal prolapse. The published literature regarding rectal mesh erosion after sacrocolpopexy includes only 6...
Placement of one of the surgeon's gloved hands into the ABDOMINAL CAVITY to perform manual manipulations that facilitate the laparoscopic procedures.
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The region in the abdomen extending from the thoracic DIAPHRAGM to the plane of the superior pelvic aperture (pelvic inlet). The abdominal cavity contains the PERITONEUM and abdominal VISCERA, as well as the extraperitoneal space which includes the RETROPERITONEAL SPACE.
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