Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)

Abstract

Introduction

Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial [1].

Methods

ACCESS is a randomized comparative effectiveness trial enrolling patients at two academic teaching facilities, UCLA (Los Angeles, CA) and Loyola University (Chicago, IL). The primary aim is to compare costs of robotic assisted versus pure laparoscopic abdominal sacrocolpopexy (RASC vs LASC). Following a clinical decision for minimally-invasive abdominal sacrocolpopexy (ASC) and research consent, participants with symptomatic stage≥II pelvic organ prolapse are randomized to LASC or RASC on the day of surgery. Costs of care are based on each patient’s billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot and initial hospitalization and any re-hospitalization in the first 6 weeks are compared between groups. Secondary outcomes include post-operative pain, anatomic outcomes, symptom severity and quality of life, and adverse events. Power calculation determined that 32 women in each arm would provide 95% power to detect a $2500 difference in total charges, using a two-sided two sample t-test with a significance level of 0.05.

Results

Enrollment was completed in May 2011. The 12-month follow-up will end in May 2012.

Conclusions

This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC.

1. Introduction

The abdominal sacrocolpopexy (ASC) is the gold standard procedure for surgical management of apical prolapse, with high long-term success rates [2]. Randomized comparative effectiveness trials and systematic literature reviews demonstrate the anatomic superiority of an ASC to transvaginal procedures for suspending the vaginal apex [3–6]. One limitation of ASC is that it requires a 8–12-cm abdominal incision that is associated with increased post-operative pain, hospital stay and post-operative complications [3,4].

Laparoscopic sacrocolpopexy (LASC) offers a minimally invasive alternative to open ASC. Instead of a single 8–12-cm abdominal incision, surgeons make 4–5 smaller incisions totaling ~3–5 cm. The post-operative advantages for the patient are somewhat offset by increased difficulty for the surgeon due to 1) a range of motion loss of both wrists inherent to laparoscopic surgical instruments and 2) reduction of the visual field to a two-dimensional image. The addition of robotic assistance results in restoration of a three-dimensional image and facilitates instrument technology mimicking the natural motion of the surgeon’s wrists.

When compared to open techniques, robotic procedures are associated with less blood loss, shorter lengths of stay, and longer operative times [7,8]. The use of robotic procedures performed worldwide nearly tripled from 2007 to 2009, from 80,000 to 205,000 cases [9]. Over the same two-year period, the number of daVinci© robotic systems installed in U.S. hospitals grew from 800 to around 1400 [9]. Despite its popularity and likely benefits over open surgery, it is not clear that robotic surgery has any benefit to the patient over laparoscopic surgery and may be associated with greater costs and longer operative times [10,11]. A recent single-site randomized trial showed longer operating times and more post-operative pain with RASC compared to LASC and similar anatomic outcomes at 1 year [12]. One small retrospective series indicates comparable outcomes between RASC and LASC with respect to cure of prolapse and procedural costs [13]. No randomized trials have primarily compared cost outcomes of RASC and LASC.

In 2009, the National Institutes of Health distributed a request for proposals as part of the American Recovery and Reinvestment Act (ARRA). This study was a response to the Specific Challenge Topic: Comparative Effectiveness of Robotic Surgery (05-EB-104). We seek to directly compare costs between laparoscopic and robotic-assisted abdominal sacrocolpopexy through a two-center randomized trial (Fig. 1).

Fig. 1.

Study schema.

2. Methods

2.1. Design overview

The Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial is a two-center randomized comparative effectiveness trial conducted at University of California — Los Angeles and Loyola University Medical Center (Chicago, IL). IRB approval for this study was obtained from both centers in January of 2009. Patients with ≥stage II pelvic organ prolapse who elect to undergo minimally invasive ASC and consent to participation in this study will be randomized to LASC or RASC. Randomization assignment will be revealed to the treating surgeon on the morning of surgery, and the patient and research staff collecting outcome measures will be blinded to surgical arm for 6 weeks after surgery. The primary outcome will be the cost effectiveness of laparoscopic compared to robotic assisted laparoscopic abdominal sacrocolpopexy for pelvic organ prolapse. The analysis will be performed from the healthcare provider’s perspective and consist of direct costs for subjects undergoing LASC and RASC. Costs will be obtained through analysis of hospital and provider charges, costs of the robot and its maintenance, and costs of disposable instruments for both treatment arms. Secondary outcomes to be measured include operative times, complications and adverse events, length of hospital stay, post-operative pain, return to normal activities, and condition specific and general health-related quality of life. Wound appearance and body image will also be compared between the two groups. Anatomic prolapse outcomes will be analyzed up to one year after surgery. This study is registered at www.clinicaltrials.gov (NCT 01124916).

2.2. Study population

Eligible women must have symptomatic stages II–IV pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification (POPQ) system [14] with significant apical descent (to 1/2 total vaginal length). The eligibility criteria are listed in Table 1.

Table 1.

Eligibility criteria.

Inclusion criteria
Stages II to IV pelvic organ prolapse by POPQ Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POP-Q point C≥TVL/2) Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI: Do you usually have the sensation of a bulging or protrusion from the vaginal area? Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Minimally invasive ASC is planned Available for 12 months of follow-up Able to complete study assessments, per clinician judgment Able and willing to provide written informed consent
Exclusion criteria Pregnancy or pregnancy in the last 12 months Plans for future child bearing Unable to read, write, and comprehend English

2.3. Baseline assessment

After enrollment and IRB consent, the following baseline data will be obtained within two months of surgery (see schedule of measures, Table 2): demographic information, medical history, list of medications, physical exam including POPQ measurements, the Brinks scale of pelvic muscle strength, and an assessment of vaginal integrity [14,15]. Health-related quality of life will be assessed with both disease-specific and general health-related validated instruments. The Short Form Health Survey (SF-36) will be used as a generic measure of health-related quality of life [16]. It consists of eight subscales, including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, and mental health. The EuroQol-5D (EQ-5D) is an additional generic measure of health-related quality of life to assess mobility, self-care, activity level, pain, and anxiety/depression [17]. Quality-of-life instruments specific to pelvic floor disorders will also be given. These include the Patient Global Impression of Improvement (PGI-I), which has been validated as a global index of response to interventions, the Hunskaar Severity Index, which assesses the frequency and severity of urinary incontinence episodes, the Pelvic Floor Distress Inventory (PFDI), and the Pelvic Floor Impact Questionnaire (PFIQ) [18,19]. The PFDI and PFIQ assess the symptoms and impact on quality of life, respectively, of pelvic floor disorders, including urinary incontinence, pelvic prolapse, and defecatory dysfunction. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), a condition-specific validated instrument that evaluates sexual function in women with pelvic organ prolapse and/or urinary incontinence, will also be completed [20].

Table 2.

Schedule of study measures.

Window for collecting measure	Baseline	Surgery (OR)	Surgery/hospital (6 h)	Surgery/hospital (24 h)	1 week (phone call)	2 weeks	4 week (phone call)	6 weeks	3 months	6 months	1-year
	–2 months		±1 h	±6 h	±2 days	±2 days	±2 days	±1 week	±1 week	±1 week	±1 month
Informed consent	X
Demographics	X
Medical history	X
Medications	X		X	X	X	X	X	X	X	X	X
Physcial Exam, POPQ	X							X	X	X	X
SF-36	X					X		X	X	X	X
EQ-5D	X					X		X	X	X	X
PGI-I	X					X		X	X	X	X
Hunskaar severity index	X					X		X	X	X	X
PFDI	X					X		X	X	X	X
PFIQ	X					X		X	X	X	X
PISQ	X								X	X	X
Body image scale	X					X		X	X	X	X
CARE	X		X	X	X	X	X	X	X	X
Activity assessment	X		X	X	X	X	X	X	X	X	X
Pain Scale	X		X	X	X	X	X	X	X	X	X
Cost/resources assessment								X			X
Photograph of trocar sites	X	X	X	X		X		X	X	X	X
Assessment of wound						X		X	X	X	X

Baseline assessments will include measurement of pain levels using Likert scales and patient convalescence using an activities assessment scale which measures the level of difficulty a patient has with activities including sitting, walking and rigorous exercise [21]. The Convalescence and Recovery Evaluation (CARE), a validated generic instrument for measuring short-term health status in the recovery period among patients undergoing abdominal and pelvic surgery, will be used to measure baseline activity levels and activity levels after surgery, such that return to baseline activity can be compared [22,23]. Photographs of the abdomen will be obtained at baseline and at different time points postoperatively and will be evaluated using a Scar Evaluation Scale (SES) [24]. Participants will complete Body Image Scale to allow assessment of the effect of surgery on their perception of their physical appearance [25].

2.4. Randomization and masking

We will block randomize study participants based on site and need for concurrent hysterectomy. The subject and study coordinator (who will obtain outcomes) will remain blinded to the assignment for the first 6-weeks of the study. Longer blinding is not feasible secondary to routine hospital billing practices. Additionally, all postoperative POPQ evaluations and assessments of pelvic floor muscle strength will be performed by a trained examiner who is blinded to the surgery assignment.

The study surgeon is providing clinical care to enrolled subjects, thus blinding the surgeon to treatment allocation or subject symptoms is not practical or feasible, other than the allocation concealment prior to surgical randomization (performed by uploading the treatment allocation on a password-protected website). The procedure on the surgical consent form will be listed as “laparoscopic sacrocolpopexy per the ACCESS protocol”. A sticker will be placed on the subject’s hospital chart indicating that she is enrolled in the ACCESS study and that the exact type of procedure performed should not be revealed to her. If unblinding does occur, the study coordinator will complete a protocol deviation form. These will be tracked and followed. To maintain blinding, the dictated operative note under the “Procedure” heading, the procedure will be listed as “laparoscopic sacrocolpopexy per the ACCESS protocol”; however, the details of the approach including use of robot assistance will be described in the text of the operative note. Similarly, all notes in the hospital chart (paper or electronic) will refer to the procedure as “laparoscopic sacrocolpopexy per the ACCESS protocol”.

2.5. Surgical intervention

The LASC involves four laparoscopic ports, including one for the camera. After lysis of adhesions is performed, the vagina is dissected free from the bladder anteriorly and from the rectum posteriorly. This is aided by the use of a vaginal stent. The fatty tissue is then dissected off the sacral promontory so that the anterior longitudinal ligament is exposed. Two separate pieces of polypropylene mesh are affixed to both the anterior and posterior vaginal walls then attached superiorly to the anterior longitudinal ligament using GoreTex® (W.L. Gore Medical Products Division, Flagstaff, AZ) sutures. Based on surgeon’s preference, the posterior peritoneum may be closed over the mesh.

The RASC utilizes five laparoscopic ports, including three for the robot, one port for the assistant, and one for the robotic camera. An initial survey of the abdomen is performed laparoscopically, and any adhesions preventing port placement are surgically released. All dissection and suturing are then performed robotically, though the steps of the operation are the same as in the laparoscopic arm.

2.6. Standardization of techniques

To avoid the variation in operative time and complication rates associated with learning new techniques, study surgeons must be competent at performing an open ASC and must have performed 10 RASC and LASC prior to enrolling study participants. Surgeon preference will determine the number of GoreTex® sutures used to attach the mesh to the vagina and sacrum. Concomitant anterior repair (paravaginal or anterior colporrhaphy) will not be allowed based on prior studies demonstrating similar anatomic outcomes with and without paravaginal repair during open ASC [26]. Distal posterior repair and/or perineorrhaphy will be decided and based on surgeon’s preference.

Concomitant retropubic midurethal sling will be allowed for the treatment and prevention of stress urinary incontinence [26,27] based on preoperative discussion with each patient. In the case of uterine prolapse, a supracervical hysterectomy will be performed first. The uterus will be morcellated and removed. The surgeon will document all additional procedures performed, and whether they were part of the peri-operative surgical plan. Wounds will all be closed with Dermabond, in order to avoid variation in wound appearance by different suturing techniques.

2.7. Post-operative assessments

We will obtain baseline and post-operative study measures as shown in Table 2. Study participants will be given the Convalescence and Recovery Evaluation (CARE), an activity assessment, and Likert pain scale post-operatively, at 6 h (±1 h) and at 24 h (±6 h). We will document their medications and will photograph the trocar sites. Our study coordinators will contact participants by phone at 1 week and at 4 weeks (±2 days). By phone the patient will be asked to review her medications, including pain medications. We will verbally give the participants the CARE, the activity assessment, and a pain scale. Office visits will take place at 2 weeks (±2 days), 6 weeks (±1 week), 3 months (±1 week), 6 months (±1 week), and 1 year (±1 month). We will collect at each of these visits the following: medications, SF-36, EQ-5D, PGI-I, Hunskaar Severity Index, PFDI, PFIQ, PISQ, Body Image Scale, CARE, activity assessment, and pain scale. We will obtain photographs of trocar sites at each of these visits. A scar evaluation form will be filled out for each trocar site, assessing the height, width, color, presence of hatched marks, and overall appearance of each trocar site. POPQ will be performed at all visits except for the visit at 2 weeks after surgery. We will query the study participants at each post-operative office visit, and during each of the two phone calls, for post-operative complications such as wound infection, cardiopulmonary complications, bowel obstruction, or other complications requiring repeat hospitalization. Surgical complications will be classified and reported using the Dindo scale [28,29].

2.8. Sample size and statistical analysis

The primary outcome measure is total operative and hospital charges. We reviewed preliminary data from a retrospective chart review study [13] that found a difference of approximately $5000 in total charges between LASC and RASC with a pooled standard deviation of $2700, although this difference was not statistically different due to a small sample size (5 cases per surgical type). Should the differences between the two treatments be greater than $2500 (as an economically relevant cut-point) then we may conclude that RASC has a greater associated cost than LASC. We propose to study 32 subjects per treatment arm. Assuming similar standard deviations to the previously published work, our study will be able to detect a difference of at least $2500 at the 0.05 significance level with 95% power (in order to balance our Type I and Type II error rates) using a two-sided two-sample t-test. Given an expected drop-out rate of 10–15% we propose to recruit a total of 74 subjects.

We will use t-tests to compare length of surgery and blood loss as continuous variables. For the other complications (wound infection, cardiopulmonary complications, etc.), we will add up the number of complications and run a chi-square testing to compare the total number of complications between the two treatment groups. For adjusted analysis, linear or logistic regression modeling will be used for continuous or categorical outcome measures, respectively. All continuous data will be reviewed graphically and the Kolmogorov–Smirnov test will be used to confirm all data follow a normal distribution prior to parametric testing. Data failing tests of normality will be appropriately transformed or tested via non-parametric methods. Data will be considered statistically different where p<0.05. Analysis will be performed using SAS v9.3 software.

2.9. Cost analysis

The objective of this economic evaluation is to determine the cost of laparoscopic compared to robotic assisted laparoscopic abdominal sacrocolpopexy for pelvic organ prolapse. Direct healthcare costs from hospital and physician’s perspective (i.e., the healthcare provider’s perspective) for subjects undergoing laparoscopic and robotic-assisted laparoscopic ASC will be obtained through analysis of hospital and provider charges, costs of the robot and its maintenance, and costs of disposable instruments for both treatment arms.

We will obtain hospital billing information from each study site and use this information to determine healthcare charges by the healthcare facility for 1) the day of the surgery and 2) the remainder of the hospitalization during which the procedure occurred. To estimate hospital costs from the hospital billing information, we will multiply the hospital charges by facility-specific cost-to-charge ratios determined from the information that the facilities submit annually to the Centers for Medicare & Medicaid Services (CMS). Because the hospitals’ charges to the patient may exceed the costs of the inputs (e.g., personnel, supplies, pharmaceuticals, laboratory) needed to provide the procedures, applying the cost-to-charge ratios to the patients’ charges allows us to assess the hospitals’ costs of providing the procedures based on the billing information[30]. Estimates of physician costs will be based on billing information (e.g., charges on the CMS 1500 form or equivalent). A cost per procedure for the robot will be estimated based on the purchase price of the robot, the number of years the robot will provide service, the annual maintenance costs of the robot, and the number of treatments for which the robot is used per year [31]. The purchase price of the robots at the two institutions was obtained from consulting with each institution. Costs of subsequent rehospitalizations during 6 weeks after discharge for the procedure will be estimated from charges recorded on uniform billing 2004 (UB-04) forms or equivalent, which will be converted to costs using facility-specific cost-to-charge ratios.

We will assess the surgery costs, which consist of the hospital costs on the day of the surgery including disposable supplies, the cost of the physicians, and the cost per treatment of the robot. We will also assess 1) the cost of the hospitalization for the procedure, which consists of the surgery costs and the costs of the remainder of the hospitalization, and 2) the total hospitalization costs including costs of any rehospitalization within 6 weeks of discharge for the initial procedure. We will examine the difference in costs between patients randomized to the robotic or laparoscopic arms of the trial:

$$\mathrm{\Delta }{\mathit{Cost}}_x={\mathit{Cost}}_{\mathit{Robotic}}-{\mathit{Cost}}_{\mathit{Laparoscopic}}$$

where Cost_x is the mean cost of the surgery, the cost of the hospitalization for the procedure, or the total hospitalization cost including any rehospitalization during six weeks after discharge for the procedure. We will calculate a 95% confidence interval (CI) around ΔCost using bootstrapping techniques. In bootstrapping, a random sample from the original data is drawn with replacement to create a new bootstrapped (BS) sample. This BS sample is different from the original sample because some observations from the original data may appear multiple times in the BS sample and some observation from the original data are not included in the BS sample. Then, the mean costs of the robotic and laparoscopic patients in the BS sample are calculated and D Cost is calculated for the BS sample. This process is repeated many times (usually ≥1000 times) to create multiple BS samples. Then, the ΔCosts from all the BS samples are sorted from smallest to largest and, after adjusting for skewness in the data, values from the upper and lower ends of this distribution are used to estimate the 95% confidence interval. If the 95% CI does not include 0, that indicates that costs are significantly different at P<0.05.

The cost difference between patients in the robotic or laparoscopic arms of the trial will depend, in part, on the cost of the robot per treatment. Because the cost per treatment of the robot depends on multiple factors including the number of treatments per year for which the robot is used for other procedures, we will assess the impact on our results of alternative scenarios in which cost per treatment of the robot assumes a range of values.

2.9.1. Measurement of effectiveness

The primary measure is the quality-adjusted life year (QALY). The QALY is the preferred metric for estimating health effects [32,33] and it reflects both the quantity and the quality of life. The EQ-5D is a validated survey instrument that will be used to collect data necessary for the calculation of QALYs. The EQ-5D instrument will be administered at baseline (pre-operation), 2 weeks and 6 weeks after surgery.

At every assessment (i.e., baseline, and 2 weeks month and 6 weeks post-surgery, respectively), each subject’s responses to the above questionnaires will be converted to the corresponding utility scores which will be used to calculate QALYs. Following prior studies, patient-level QALYs will be calculated assuming linear changes in each subject’s utility values over time between every two assessments and calculating the area under the curve over the 2 week and 6 week periods. To account for potential imbalance in mean baseline utility between the two trial arms, multiple regression approach will be adopted as recommended in Manca et al. [34] where treatment arm will be included as an indicator variable. The model will adjust for the two surgical stratification variables in the randomization, baseline utility, and other subject characteristics that are found to differ significantly between the two arms. The estimate of the coefficient for treatment arm indicator will reflect the differential QALYs between the two arms (adjusting for the effects of other covariates). The model will be replicated for quality of life measures obtained from EQ-5D. Our approach will allow for comparison of research findings with other studies (by using the generic health-related quality of life measure).

2.9.2. Cost-effectiveness analysis (CEA)

The analysis discussed under the Measurement of effectiveness section will reveal the differential QALYs between the laparoscopic and robotic assisted laparoscopic ASC arms. If the analysis found no statistically significant difference in QALYs (i.e., the two trial arms have equivalent effectiveness), the economic evaluation will be conducted as a cost-minimization study to determine which surgical strategy entails lower costs. Results from the analysis described above will inform us of such effects.

If, however, a significant difference is found between the two arms in subjects’ QALYs, we will consider the following possible scenarios. If one of the surgical strategies is shown to be both less costly and more effective, it dominates the competitor as the more cost-effective strategy. If instead one of the strategies is more costly but generates higher QALYs, an incremental cost–effectiveness ratio (ICER) will be calculated to assess the incremental costs associated with each additional QALY gained. Specifically, ICER is defined as:

$$\left({\mathit{cost}}_{\mathit{robotic}}-{\mathit{cost}}_{\mathit{lap}}\right)/\left({\mathit{effectiveness}}_{\mathit{robotic}}-{\mathit{effectiveness}}_{\mathit{lap}}\right).$$

The mean ICER will be calculated using the original trial data. Mean differential costs and differential QALYs between the two arms obtained from the multiple regression analyses will be used for this purpose. Non-parametric bootstrapping re-sampling technique (1000 iterations) will be used to derive the 95% confidence intervals for the ICER. Thus generated cost–effect pairs will also be used to derive the cost–effectiveness acceptability curves (CEACs). While conducting the cost-effectiveness analysis, we will also compare the resource utilization profile and the associated costs between the two groups. Several categories of resource use, including physician visits, laboratory tests, hospital stay, medications, etc., will be examined.

Our experience from the other multicenter surgical trials [26] suggests that few subjects will drop out during the follow-up period. The base case CEA will be conducted based on data from subjects with complete cost and effectiveness data. By doing so, we assume that data are missing completely at random and the complete cases are fully representative of the cases in the original sample. Sensitivity analysis will be performed to include the information of subjects with incomplete (i.e., missing) data (e.g., lost to follow up in one of the postoperative assessments). Multiple imputation method will be used to impute the missing data. This will shed light on the influence of imputation on the results of

2.10. Efficacy

The stage of pelvic organ prolapse will be quantified pre-operatively using the POPQ system. Degree of bother from prolapse symptoms will be measured using the PFDI and its subscales. Since the PDFI is a continuous scale, we will run t-tests at each time point for unadjusted analysis and a linear regression to adjust for covariates. We will also perform a repeated measures analysis to look at trends over time. We will be powering the study and recruiting patients based on our primary outcome measures. Therefore, we do not anticipate detecting differences in prolapse recurrence between the two surgical techniques at 1 year after surgery due to insufficient power. Nonetheless, our findings may shed light on prolapse outcomes over time between the two treatment arms.

3. Results

Demographic data will be presented in tabular form for all cases and by minimally-invasive approach (laparoscopic vs. robotic assisted). Demographic variables will include age, race, household income, medical comorbidities, menopausal status, previous pelvic surgery and concurrent procedures performed at the time of minimally invasive sacrocolpopexy. Results in table shells are shown (see Tables 3, 4 and 5).

Table 3.

Surgical and cost outcomes.

	Laparoscopic	Robotic	p-value
	Mean (SD)	Mean (SD)
Estimated blood loss total (cc)
Estimated blood loss ASC (cc)
Procedure time (min)
Total surgery time (min)
Hospital charges
Hospital charges over 6 weeks
Hospital charges excluding robot
Hospital charges over 6 weeks excluding robot

Table 4.

Costs and quality of life measures laparoscopic vs. robotic.

	Laparoscopic (n=) mean (SD)	Robotic (n=) mean (SD)	p-Value
Day of surgery without robot costs
Total cost after six weeks without robot costs ($)
Day of surgery with robot costs ($)
Total cost after six weeks with robot costs ($)
EQ-5D
Baseline
1-year
QALY
1-year

^*Difference is significant with bias corrected bootstrap analysis with 2000 replications.

Table 5.

Clinical outcomes.

	Laparoscopic			Robotic			Treatment effect p-value
	Baseline	3 months	6 months	Baseline	3 months	6 months
	Mean	Mean	Mean	Mean	Mean	Mean
	(SD)	(SD)	(SD)	(SD)	(SD)	(SD)
POPQ (cm)
Point Ba
POPQ (cm)
Point C
POPQ (cm)
Point Bp
UDIa
POPDIa
CRADIa
UIQa
CRAIQa
POPIQa

^aPFDI and PFIQ subscale scores range from 0 to 400 with higher scores indicating worsening symptoms.

4. Discussion

Health care costs rise for many reasons, only one of which is technological advancement. Patients and doctors alike often embrace new technologies, despite a lack of level I data to support their use. Robot-assisted surgery is one such technology that has been widely embraced by both surgeons and patients. Robotics has been applied to a wide range of procedures, including those already performed laparoscopically before the introduction of the robot, as well as those primarily performed via laparotomy. Barbash and Glied analyzed data from the National Inpatient Sample in 2007, and found over a 60% increase in the number of hospitalizations for prostatectomy between 2005 and 2008, correlating with an introduction of robotic technology. It appears that robotic technology has not only increased the substitution of robotic for open surgery, but may have also resulted in a substitution of surgical for nonsurgical treatments for prostate cancer, such as radiation therapy[9]. The authors conclude that, by increasing both the number and type of surgeries performed robotically, robotic technology will have a tremendous impact on health care expenditures.

4.1. Limitations

The main strengths of the ACCESS study are its application of a randomized clinical trial using rigorous methodology at two centers. However, it is possible that patients get unmasked and are told of their randomization assignment during their hospitalization. Certain complications that significantly prolong hospitalization could exaggerate the cost of a given arm. However, costs of such complications will be analyzed separately. Also, we may not be able to capture all complications and costs accrued after a patient leaves the hospital, particularly if she is treated outside of our centers.

Surgeon experience may limit the generalizability of this study. The study surgeons were required to perform a minimum of 10 laparoscopic and robotic procedures prior to enrolling patients in the ACCESS trial. One limitation is that the majority of study surgeons had more experience performing these procedures robotically. This would favor the robotic approach with lower operative times and possible complications. An additional limitation is that the cost estimates were based on the charges at two facilities. There are many facility and regional characteristics that may impact costs, charges, and outcomes that may affect the generalizability of the results. Nonetheless, the ACCESS study will provide a real-world portrait of the true cost differences between robotic-assisted and conventional laparoscopic approaches to sacrocolpopexy, so that surgeons and their patients can make informed decisions about the adoption of new technologies [9].

5. Conclusion

The ACCESS study is a multi-center randomized study designed to address the cost-effectiveness of using robotic assistance during a laparoscopic sacrocolpopexy. Comparative effectiveness research is critical to determine the benefit of robotic-assisted approaches. Knowledge of the true cost differences between robotic and laparoscopic sacrocolpopexy is necessary to inform policy in an era of growing health care costs.