Comparative effectiveness of biofeedback and injectable bulking agents for treatment of fecal incontinence: Design and methods.

Fecal incontinence (FI), the involuntary passage of stool, is common and can markedly impair the quality of life. Among patients who fail initial options (pads or protective devices, bowel modifying agents, and pelvic floor exercises), the options are pelvic floor biofeedback (BIO), perianal injection with bulking agents (INJ), and sacral nerve electrical stimulation (SNS), which have not been subjected to head-to-head comparisons. This study will compare the safety and efficacy of BIO and INJ for managing FI. The impact of these approaches on quality-of-life and psychological distress, cost effectiveness, and predictors of response to therapy will also be evaluated. Six centers in the United States will enroll approximately 285 patients with moderate to severe FI. Patients who have 4 or more FI episodes over 2 weeks proceed to a 4-week trial of enhanced medical management (EMM) (ie, education, bowel management, and pelvic floor exercises). Thereafter, 194 non-responders as defined by a less than 75% reduction in the frequency of FI will be randomized to BIO or INJ. Three months later, the efficacy, safety, and cost of therapy will be assessed; non-responders will be invited to choose to add the other treatment or SNS for the remainder of the study. Early EMM responders will be re-evaluated 3 months later and non-responders randomized to BIO or INJ. Standardized, and where appropriate validated approaches will be used for study procedures, which will be performed by trained personnel. Prospectively collected data on care costs and resource utilization will be used for cost effectiveness analyses.

Cost-effectiveness Evaluation of Laparoscopic Versus Robotic Minimally Invasive Colectomy.

OBJECTIVE: Evaluate the cost-effectiveness of open, laparoscopic, and robotic colectomy. BACKGROUND: The use of robotic-assisted colon surgery is increasing. Robotic technology is more expensive and whether a robotically assisted approach is cost-effective remains to be determined. METHODS: A decision-analytic model was constructed to evaluate the 1-year costs and quality-adjusted time between robotic, laparoscopic, and open colectomy. Model inputs were derived from available literature for costs, quality of life (QOL), and outcomes. Results are presented as incremental cost-effectiveness ratios (ICERs), defined as incremental costs per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were performed to test the effect of clinically reasonable variations in the inputs on our results. RESULTS: Open colectomy cost more and achieved lower QOL than robotic and laparoscopic approaches. From the societal perspective, robotic colectomy costs $745 more per case than laparoscopy, resulting in an ICER of $2,322,715/QALY because of minimal differences in QOL. From the healthcare sector perspective, robotics cost $1339 more per case with an ICER of $4,174,849/QALY. In both models, laparoscopic colectomy was more frequently cost-effective across a wide range of willingness-to-pay thresholds. Sensitivity analyses suggest robotic colectomy becomes cost-effective at $100,000/QALY if robotic disposable instrument costs decrease below $1341 per case, robotic operating room time falls below 172 minutes, or robotic hernia rate is less than 5%. CONCLUSIONS: Laparoscopic and robotic colectomy are more cost-effective than open resection. Robotics can surpass laparoscopy in cost-effectiveness by achieving certain thresholds in QOL, instrument costs, and postoperative outcomes. With increased use of robotic technology in colorectal surgery, there is a burden to demonstrate these benefits.

System-Wide Improvement for Transitions After Ileostomy Surgery: Can Intensive Monitoring of Protocol Compliance Decrease Readmissions? A Randomized Trial.

BACKGROUND: Hospital readmission is common after ileostomy formation and frequently associated with dehydration. OBJECTIVE: This study was conducted to evaluate a previously published intervention to prevent dehydration and readmission. DESIGN: This is a randomized controlled trial. SETTING: This study was conducted in 3 hospitals within a single health care system. PATIENTS: Patients undergoing elective or nonelective ileostomy as part of their operative procedure were selected. INTERVENTION: Surgeons, advanced practice providers, inpatient and outpatient nurses, and wound ostomy continence nurses participated in a robust ileostomy education and monitoring program (Education Program for Prevention of Ileostomy Complications) based on the published intervention. After informed consent, patients were randomly assigned to a postoperative compliance surveillance and prompting strategy that was directed toward the care team, versus usual care. OUTCOME MEASURES: Unplanned hospital readmission within 30 days of discharge, readmission for dehydration, acute renal failure, estimated direct costs, and patient satisfaction were the primary outcomes measured. RESULTS: One hundred patients with an ileostomy were randomly assigned. The most common indications were rectal cancer (n = 26) and ulcerative colitis (n = 21), and 12 were emergency procedures. Although intervention patients had better postdischarge phone follow-up (90% vs 72%; p = 0.025) and were more likely to receive outpatient intravenous fluids (25% vs 6%; p = 0.008), they had similar overall hospital readmissions (20.4% vs 19.6%; p = 1.0), readmissions for dehydration (8.2% vs 5.9%; p = 0.71), and acute renal failure events (10.2% vs 3.9%; p = 0.26). Multivariable analysis found that weekend discharges to home were significantly associated with readmission (OR, 4.5 (95% CI, 1.2-16.9); p = 0.03). Direct costs and patient satisfaction were similar. LIMITATIONS: This study was limited by the heterogeneous patient population and by the potential effect of the intervention on providers taking care of patients randomly assigned to usual care. CONCLUSIONS: A surveillance strategy to ensure compliance with an ileostomy education program tracked patients more closely and was cost neutral, but did not result in decreased hospital readmissions compared with usual care. See Video Abstract at http://links.lww.com/DCR/A812.

A novel approach to assessing technical competence of colorectal surgery residents: the development and evaluation of the Colorectal Objective Structured Assessment of Technical Skill (COSATS).

OBJECTIVE: To develop and evaluate an objective method of technical skills assessment for graduating subspecialists in colorectal (CR) surgery-the Colorectal Objective Structured Assessment of Technical Skill (COSATS). BACKGROUND: It may be reasonable for the public to assume that surgeons certified as competent have had their technical skills assessed. However, technical skill, despite being the hallmark of a surgeon, is not directly assessed at the time of certification by surgical boards. METHODS: A procedure-based, multistation technical skills examination was developed to reflect a sample of the range of skills necessary for CR surgical practice. These consisted of bench, virtual reality, and cadaveric models. Reliability and construct validity were evaluated by comparing 10 graduating CR residents with 10 graduating general surgery (GS) residents from across North America. Expert CR surgeons, blinded to level of training, evaluated performance using a task-specific checklist and a global rating scale. The mean global rating score was used as the overall examination score and a passing score was set at "borderline competent for CR practice." RESULTS: The global rating scale demonstrated acceptable interstation reliability (0.69) for a homogeneous group of examinees. Both the overall checklist and global rating scores effectively discriminated between CR and GS residents (P < 0.01), with 27% of the variance attributed to level of training. Nine CR residents but only 3 GS residents were deemed competent. CONCLUSIONS: The Colorectal Objective Structured Assessment of Technical Skill effectively discriminated between CR and GS residents. With further validation, the Colorectal Objective Structured Assessment of Technical Skill could be incorporated into the colorectal board examination where it would be the first attempt of a surgical specialty to formally assess technical skill at the time of certification.