Objective Performance Indicators During Robotic Right Colectomy Differ According to Surgeon Skill.

INTRODUCTION: Surgeon assessment tools are subjective and nonscalable. Objective performance indicators (OPIs), machine learning-enabled metrics recorded during robotic surgery, offer objective insights into surgeon movements and robotic arm kinematics. In this study, we identified OPIs that significantly differed across expert (EX), intermediate (IM), and novice (NV) surgeons during robotic right colectomy. METHODS: Endoscopic videos were annotated to delineate 461 surgical steps across 25 robotic right colectomies. OPIs were compared among two EX, two IM, and eight NV surgeons during mesenteric dissection, vascular pedicle ligation, right colon and hepatic flexure mobilization, and preparation of the proximal and distal bowel for transection. RESULTS: Compared to NV's, EX's exhibited greater velocity, acceleration and jerk for camera, dominant, nondominant, and third arms across all steps. Compared to NV's, IM's exhibited more arm swaps and master clutch use, higher camera-related metrics (movement, path length, moving time, velocity, acceleration, and jerk), greater dominant wrist pitch and nondominant wrist articulations (roll, pitch, and yaw), longer dominant and nondominant arm path length, and higher velocity, acceleration and jerk for dominant, nondominant, and third arms across all steps. Compared to NV's, EX/IM surgeons utilized more arm swaps, higher camera-related metrics (movement, path length, velocity, acceleration, and jerk), longer nondominant arm path length, and greater velocity, acceleration and jerk for dominant, nondominant, and third arms across all steps. CONCLUSIONS: We report OPIs that discriminate EX, IM, and NV surgeons during RRC. This study is the first to demonstrate feasibility of using OPIs as an objective, scalable way to classify surgeon skill during RRC steps.

Objective performance indicators differ in obese and nonobese patients during robotic proctectomy.

BACKGROUND: Robotic surgery is perceived to be more complex in obese patients. Objective performance indicators, machine learning-enabled metrics, can provide objective data regarding surgeon movements and robotic arm kinematics. In this feasibility study, we identified differences in objective performance indicators during robotic proctectomy in obese and nonobese patients. METHODS: Endoscopic videos were annotated to delineate individual surgical steps across 39 robotic proctectomies (1880 total steps). Thirteen patients were obese and 26 were nonobese. Objective performance indicators during the following steps were analyzed: splenic flexure mobilization, left colon mobilization, pelvic dissection, and rectal transection. RESULTS: The following differences were noted during robotic proctectomy in obese patients: during splenic flexure mobilization, more arm swaps, longer camera path length and velocity; during left colon mobilization, longer step time, more arm swaps, higher camera-related metrics (movement, path length, velocity, acceleration, and jerk), greater dominant arm path length, moving time, and wrist articulation; during anterior pelvic dissection, longer energy activation time, camera path length, and moving time; during posterior pelvic dissection, lower nondominant arm velocity, jerk, and acceleration; during left pelvic dissection, longer energy activation time; during right pelvic dissection, greater camera-related metrics (movement, path length, moving time, and velocity); and during rectal transection, longer step time, more arm swaps, master clutch use and camera movements, greater dominant wrist articulation, and longer dominant arm path length. CONCLUSION: We report step-specific objective performance indicators that differ during robotic proctectomy for obese and nonobese patients. This is the first study to use objective performance indicators to correlate a patient attribute with surgeon movements and robotic arm kinematics during robotic colorectal surgery.

Objective performance indicators during specific steps of robotic right colectomy can differentiate surgeon expertise.

BACKGROUND: Current surgical assessment tools are subjective and nonscalable. Objective performance indicators, calculated from robotic systems data, provide automated data regarding surgeon movements and robotic arm kinematics. We identified objective performance indicators that significantly differed among expert and trainee surgeons during specific steps of robotic right colectomy. METHODS: Endoscopic videos were annotated to delineate surgical steps during robotic right colectomies. Objective performance indicators were compared during mesenteric dissection, ascending colon mobilization, hepatic flexure mobilization, and bowel preparation for transection. RESULTS: Twenty-five robotic right colectomy procedures (461 total surgical steps) performed by 2 experts and 8 trainees were analyzed. Experts exhibited faster camera acceleration and jerk during all steps, as well as faster dominant and nondominant arm acceleration and dominant arm jerk during all steps except distal bowel preparation. During mesenteric dissection, experts used faster camera and dominant arm velocity. During medial-to-lateral ascending colon mobilization, experts used less-dominant wrist yaw and pitch, faster nondominant arm velocity, shorter dominant arm path length, and shorter moving times for camera, dominant arm, and nondominant arm. During lateral-to-medial ascending colon mobilization, experts had faster dominant and nondominant arm velocity and third-arm acceleration. During hepatic flexure mobilization, experts exhibited more camera movements, greater velocity for camera, dominant and nondominant arms, and faster third-arm acceleration. During distal bowel preparation, experts used greater dominant wrist articulation, faster camera velocity, and longer nondominant arm path length. During proximal bowel preparation, experts demonstrated faster nondominant arm velocity. CONCLUSION: Objective performance indicators can differentiate experts from trainees during distinct steps of robotic right colectomy. These automated, objective and scalable metrics can provide personalized feedback for trainees.

Management of a Complex Fistula Involving Abdominal Wall, Small Bowel, Colon, and Bladder.

Successful surgical management of a chronic complex abdominal fistula requires thoughtful pre-operative evaluation and planning and often benefits from a multi-disciplinary approach. Initially, attention is focused on controlling sepsis and ensuring adequate hydration and electrolyte replacement. Next, efforts to optimize nutrition and engage the patient in prehabilitation are prioritized. Simultaneously, imaging is used to gain detailed assessment of anatomy. We present a challenging case involving a Jackson-Pratt (JP) drain from prior surgery causing a complex intra-abdominal fistula. The JP drain traversed multiple small bowel loops and the sigmoid colon before terminating in the bladder. Management required multi-disciplinary coordination involving colorectal surgery and urology. The patient's definitive surgery included anterior resection, colostomy takedown, right colectomy, three small bowel resections, and bladder repair. The use of JP drains after abdominal surgery is not without risk. Clinicians should have standardized indications for placement of JP drains and consistent protocols regarding timing of removal.

Quantification of surgical workflow during robotic proctectomy.

BACKGROUND: Surgical workflow assessments offer insight regarding procedure variability. We utilised an objective method to evaluate workflow during robotic proctectomy (RP). METHODS: We annotated 31 RPs and used Spearman's correlation to measure the correlation of step time and step visit frequency with console time (CT) and total operative time (TOT). RESULTS: Strong correlations were seen with CT and step times for inferior mesenteric vein dissection and ligation (ρ = 0.60, ρ = 0.60), lateral-to-medial splenic flexure mobilisation (SFM) (ρ = 0.63), left rectal dissection (ρ = 0.64) and mesorectal division (ρ = 0.71). CT correlated strongly with medial-to-lateral (ρ = 0.75) and supracolic SFM visit frequency (ρ = 0.65). TOT correlated strongly with initial exposure time (ρ = 0.60), and medial-to-lateral (ρ = 0.67) and supracolic SFM visit frequency (ρ = 0.65). CONCLUSION: This study correlates surgical steps with CT and TOT through standardised annotation, providing an objective approach to quantify workflow.

Quantification of Surgical Workflow during Robotic Proctectomy.

Aim: Assessments of surgical workflow offer insight regarding procedure variability, case complexity and surgeon proficiency. We utilize an objective method to evaluate step-by-step workflow and step transitions during robotic proctectomy (RP). Methods: We annotated 31 RPs using a procedure-specific annotation card. Using Spearman's correlation, we measured strength of association of step time and step visit frequency with console time (CT) and total operative time (TOT). Results: Across 31 RPs, a mean (± standard deviation) of 49.0 (± 20.3) steps occurred per procedure. Mean CT and TOT were 213 (± 90) and 283 (± 108) minutes. Posterior mesorectal dissection required most visits (8.7 ± 5.0), while anastomosis required most time (18.0 [± 8.5] minutes). Inferior mesenteric vein (IMV) ligation required least visits (1.0 ± 0.0) and lowest duration (0.9 [± 0.5] minutes). Strong correlations were seen with CT and step times for IMV dissection and ligation (ρ = 0.60 for both), lateral-to-medial splenic flexure mobilization (SFM) (ρ = 0.63), left rectal dissection (ρ = 0.64) and mesorectal division (ρ = 0.71). CT correlated strongly with medial-to-lateral and supracolic SFM visit frequency (ρ = 0.75 and ρ = 0.65). There were strong correlations with TOT and initial exposure time (ρ = 0.60), as well as visit frequency for medial-to-lateral (ρ = 0.67) and supracolic SFM (ρ = 0.65). Descending colon mobilization was nodal, rectal mobilization convergent and rectal transection divergent. Conclusion: This study correlates individual surgical steps with CT and TOT through standardized annotation. It provides an objective approach to quantify workflow.

Ratio of Economy of Motion: A New Objective Performance Indicator to Assign Consoles During Dual-Console Robotic Proctectomy.

BACKGROUND: Our group investigates objective performance indicators (OPIs) to analyze robotic colorectal surgery. Analyses of OPI data are difficult in dual-console procedures (DCPs) as there is currently no reliable, efficient, or scalable technique to assign console-specific OPIs during a DCP. We developed and validated a novel metric to assign tasks to appropriate surgeons during DCPs. METHODS: A colorectal surgeon and fellow reviewed 21 unedited, dual-console proctectomy videos with no information to identify the operating surgeons. The reviewers watched a small number of random tasks and assigned "attending" or "trainee" to each task. Based on this sampling, the remainder of task assignments for each procedure was extrapolated. In parallel, we applied our newly developed OPI, ratio of economy of motion (rEOM), to assign consoles. Results from the 2 methods were compared. RESULTS: A total of 1811 individual surgical tasks were recorded during 21 proctectomy videos. A median of 6.5 random tasks (137 total) were reviewed during each video, and the remainder of task assignments were extrapolated based on the 7.6% of tasks audited. The task assignment agreement was 91.2% for video review vs rEOM, with rEOM providing ground truth. It took 2.5 hours to manually review video and assign tasks. Ratio of economy of motion task assignment was immediately available based on OPI recordings and automated calculation. DISCUSSION: We developed and validated rEOM as an accurate, efficient, and scalable OPI to assign individual surgical tasks to appropriate surgeons during DCPs. This new resource will be useful to everyone involved in OPI research across all surgical specialties.

Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors.

BACKGROUND: Targeting programmed cell death protein 1 (PD-1) and indoleamine 2,3-dioxygenase (IDO1) pathways is an appealing option for cancer treatment. METHODS: The open-label, phase 1/2 ECHO-203 study evaluated the safety, tolerability, and efficacy of the IDO1 inhibitor epacadostat in combination with durvalumab, a human anti-PD-L1 monoclonal antibody in adult patients with advanced solid tumors. RESULTS: The most common treatment-related adverse events were fatigue (30.7%), nausea (21.0%), decreased appetite (13.1%), pruritus (12.5%), maculopapular rash (10.8%), and diarrhea (10.2%). Objective response rate (ORR) in the overall phase 2 population was 12.0%. Higher ORR was observed in immune checkpoint inhibitor (CPI)-naïve patients (16.1%) compared with patients who had received previous CPI (4.1%). Epacadostat pharmacodynamics were evaluated by comparing baseline kynurenine levels with those on therapy at various time points. Only the 300-mg epacadostat dose showed evidence of kynurenine modulation, albeit unsustained. CONCLUSIONS: Epacadostat plus durvalumab was generally well tolerated in patients with advanced solid tumors. ORR was low, and evaluation of kynurenine concentration from baseline to cycle 2, day 1, and cycle 5, day 1, suggested >300 mg epacadostat twice daily is needed to ensure sufficient drug effect. CLINICAL TRIAL INFORMATION: A study of epacadostat (INCB024360) in combination with durvalumab (MEDI4736) in subjects with selected advanced solid tumors (ECHO-203) (NCT02318277).

Robotic Proctectomy: Beyond the Initial Learning Curve.

BACKGROUND: Multiple authors have described an initial learning curve (LC) for robotic proctectomy (RP), but there is scant literature regarding continued technical progression beyond this stage. Total operating time is the most commonly used metric to measure proficiency. Our goal was to examine RP experience after the initial LC looking for evidence of further technical progression. METHODS: We reviewed our robotic surgery database for a single surgeon during operations 100 through 550 to identify 83 RPs for tumor. These were divided into quartiles by series order, indicating surgeon experience level over time. Demographics and outcomes were compared among the groups. We defined percent console time (PCT) as a new metric. PCT was defined as console time divided by total operative time (TOT). RESULTS: From March 2014 through March 2019, 450 robotic colorectal operations were performed, including 83 RPs for polyp or cancer. No significant differences were found among the quartiles in regard to demographics, tumor features, hospital stay, conversions, or readmissions. As experience was gained, there were significant increases in intracorporeal anastomosis (ICA), TOT, and PCT. Complications decreased with experience. Number of lymph nodes in the specimen increased. On multivariate analysis, later experience group, body mass index ≥30, and ICA were associated with increased PCT. DISCUSSION: ICA became a routine part of RP after the initial LC, with increases in TOT and PCT. Number of lymph nodes increased and number and severity of complications decreased with experience. Increased PCT may indicate increased expertise during RP.

Are current credentialing requirements for robotic surgery adequate to ensure surgeon proficiency?

BACKGROUND: Robotic surgery has seen unprecedented growth, requiring hospitals to establish or update credentialing policies regarding this technology. Concerns about verification of robotic surgeon proficiency and the adequacy of current credentialing criteria to maintain patient safety have arisen. The aim of this project was to examine existing institutional credentialing requirements for robotic surgery and evaluate their adequacy in ensuring surgeon proficiency. METHODS: Robotic credentialing policies for community and academic surgery programs were acquired and reviewed. Common criteria across institutions related to credentialing and recredentialing were identified and the average, standard deviation, and range of numeric requirements, if defined, was calculated. Criteria for proctors and assistants were also analyzed. RESULTS: Policies from 42 geographically dispersed US hospitals were reviewed. The majority of policies relied on a defined number of proctored cases as a surrogate for proficiency with an average of 3.24 ± 1.69 and a range of 1-10 cases required for initial credentialing. While 34 policies (81%) addressed maintenance of privileges requirements, there was wide variability in the average number of required robotic cases (7.19 ± 3.28 per year) and range (1-15 cases per year). Only 11 policies (26%) addressed the maximum allowable time gap between robotic cases. CONCLUSION: Significant variability in credentialing policies exists in a representative sample of US hospitals. Most policies require completion of a robotic surgery training course and a small number of proctored cases; however, ongoing objective performance assessments and patient outcome monitoring was rarely described. Existing credentialing policies are likely inadequate to ensure surgeon proficiency; therefore, development and wide implementation of robust credentialing guidelines is recommended to optimize patient safety and outcomes.

Case report of surgical management of a locally invasive colostomy adenocarcinoma.

INTRODUCTION: This case report involves the presentation and management of a locally invasive adenocarcinoma at the site of a colostomy in a patient with multiple comorbidities and anatomic constraints. PRESENTATION OF CASE: 63 year-old woman with a complicated medical and surgical history, including imperforate anus and permanent colostomy, who presented with a fungating mass at the site of her colostomy. Evaluation revealed a locally invasive adenocarcinoma requiring surgical management for symptom control and oncologic treatment. DISCUSSION: Due to the patient's medical comorbidities, body habitus, prior surgery, prior radiation and locally invasive cancer, there were numerous physiologic and anatomic issues that required a multi-disciplinary approach. Specifically, consideration of the patient's prior radiation to the left chest, history of cystectomy and ileal conduit, history of prior colon resection, as well as her short stature and severe kyphosis required input from urology, plastic surgery and colorectal surgery for operative planning. The patient's chronic renal insufficiency, recurrent urinary tract infections and history of thromboembolic disease further complicated her perioperative management. Oncologic resection with wide local excision at the skin and abdominal wall were performed with mass closure of the midline and peristomal abdominoplasty, using mesh underlay. The patient's postoperative course was complicated by gastric outlet obstruction and recurrent urosepsis. CONCLUSIONS: Patients with chronic colostomies require colon cancer screening similar to their non-stoma peers, in accordance with national guidelines. Oncologic resection of cancers involving colostomies is feasible, but may require multi-disciplinary planning to manage complicated anatomic concerns.

Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies.

PURPOSE: Bromodomain and extraterminal (BET) proteins are key epigenetic transcriptional regulators, inhibition of which may suppress oncogene expression. We report results from 2 independent first-in-human phase 1/2 dose-escalation and expansion, safety and tolerability studies of BET inhibitors INCB054329 (study INCB 54329-101; NCT02431260) and INCB057643 (study INCB 57643-101; NCT02711137). PATIENTS AND METHODS: Patients (≥18 years) with advanced malignancies, ≥1 prior therapy, and adequate organ functions received oral INCB054329 (monotherapy) or INCB057643 (monotherapy or in combination with standard-of-care) in 21-day cycles (or 28-day cycles depending on standard-of-care combination). Primary endpoints were safety and tolerability. RESULTS: Sixty-nine and 134 patients received INCB054329 and INCB057643, respectively. Study INCB 54329-101 has been completed; INCB 57643-101 is currently active, but not recruiting (no patients were receiving treatment as of January 8, 2019). Terminal elimination half-life was shorter for INCB054329 versus INCB057643 (mean [SD], 2.24 [2.03] vs. 11.1 [8.27] hours). INCB054329 demonstrated higher interpatient variability in oral clearance versus INCB057643 (CV%, 142% vs. 45.5%). Most common (>20%) any-grade treatment-related adverse events were similar for both drugs (INCB054329; INCB057643): nausea (35%; 30%), thrombocytopenia (33%; 32%), fatigue (29%; 30%), decreased appetite (26%; 22%). Two confirmed complete responses and 4 confirmed partial responses with INCB057643 were reported as best responses. CONCLUSIONS: INCB057643 exhibited a more favorable PK profile versus INCB054329; exposure-dependent thrombocytopenia was observed with both drugs which limited the target inhibition that could be safely maintained. Further efforts are required to identify patient populations that can benefit most, and an optimal dosing scheme to maximize therapeutic index.

How robotics is changing and will change the field of colorectal surgery.

During the last decade there has been a significant upward trend in colon and rectal minimally invasive surgery which can be attributed largely to the acceptance of robotic surgery platforms such as the da Vinci® robotic system. The fourth generation da Vinci® system, introduced in 2014, includes integrated table motion, intelligent laser targeted docking and more sophisticated instrumentation and imaging. These developments have enabled more surgeons to efficiently and safely perform multi-quadrant operations. Firefly® technology allows assessment of colon perfusion and identification of ureters, and has shown potential in detecting occult recurrence or metastasis using molecular-labelled tumor markers. Wristed instrumentation has increased the technical ease of intracorporeal anastomosis (ICA) for many surgeons, leading to more common use of ICA during right colectomy. Advanced imaging has shown potential to decrease the incidence of presacral nerve injury and improve urogenital outcomes after pelvic surgery, as has been the case in robotic urologic procedures. Finally, the robotic platform lends itself to surgical simulation for surgical trainees, as a pre-operative tool for mock operations and as an ongoing assessment tool for established colorectal surgeons. Given these advantages, surgeons should anticipate continued and increased utilization of this beneficial technology.

A Curious Case of Autoimmune Pancreatitis with IgG4-related Sclerosing Cholangitis.

Immunoglobulin G4-related sclerosing cholangitis (IgG4-SC) is a novel entity that belongs to the immune-mediated fibroinflammatory class of IgG4-related diseases (IgG4-RD). IgG4-SC is noted to be one of the most frequent manifestations of extra-pancreatic disease among IgG4-RD, which is significantly different from primary SC (PSC) and cholangiocarcinoma (CC) as is evident in the varied approaches to treatment. IgG4-RD includes IgG4-SC and autoimmune pancreatitis (AIP). Herein, we presented a case of IgG4-SC in a patient with obstructive jaundice secondary to AIP. We have also discussed the current recommendations for diagnostic and treatment modalities, with an emphasis on the issues that arise in obtaining a definitive classification of disease.

Robotic-assisted surgery for complicated and non-complicated diverticulitis: a single-surgeon case series.

Laparoscopic colectomy is the preferred approach for surgical management of non-complicated diverticulitis, with lower complication rates, shorter length of stay, and decreased narcotic use compared with open surgery. Complicated diverticulitis, characterized by abscess, fistula or stricture, is more difficult to manage with minimally invasive surgery, with reports of higher conversion rates, prolonged operative time, longer length of stay, and increased complication rates. The robotic platform may provide an alternative safe and feasible option for managing complicated diverticulitis with minimally invasive surgery. A prospectively maintained database of robotic-assisted colorectal surgery performed at our university-affiliated community hospital was used to identify consecutive patients who underwent robotic-assisted surgery for complicated or non-complicated diverticulitis. Thirty-two patients with non-complicated diverticulitis and 36 patients with complicated diverticulitis had surgery between January, 1, 2014 and September 30, 2017. The database was used to compare the two groups of patients in regard to operative time, estimated blood loss, ureteral stent usage, conversions, ostomies, pelvic drains, post-operative complications, length of stay, return of bowel function, and post-operative narcotic use. Comparison of the two groups revealed significant differences in operative times (172 vs. 196 min, p = 0.01), conversions (3.1% vs. 22.2%, p = 0.03), ostomies (9.4% vs. 33.3%, p = 0.04), and pelvic drains (3.2% vs. 28.6%, p = 0.02). No significant differences were noted for estimated blood loss, complications, return of bowel function, narcotic use, length of stay, or readmissions. Four complicated diverticulitis patients had intra-operative ureteral stents, and there were no ureteral injuries in either group. Patients with complicated diverticulitis required longer operative time, and more often required conversion, an ostomy, and a pelvic drain. Robotic-assisted surgery is safe and feasible for both non-complicated and complicated diverticulitis.

A single surgeon's experience transitioning to robotic-assisted right colectomy with intracorporeal anastomosis.

BACKGROUND: Despite substantial evidence demonstrating benefits of minimally invasive surgery, a large percentage of right colectomies are still performed via an open technique. Most laparoscopic right colectomies are completed as a hybrid procedure with extracorporeal anastomosis. As part of a pure minimally invasive procedure, intracorporeal anastomosis (ICA) may confer additional benefits for patients. The robotic platform may shorten the learning curve for minimally invasive right colectomy with ICA. METHODS: From January 2014 to May 2016, 49 patients underwent robotic-assisted right colectomy by a board-certified colorectal surgeon (S.R). Extracorporeal anastomosis (ECA) was used in the first 20 procedures, whereas ICA was used in all subsequent procedures. Outcomes recorded in a database for retrospective review included operating time (OT), estimated blood loss (EBL), length of stay (LOS), conversion rate, complications, readmissions, and mortality rate. RESULTS: Comparison of average OT, EBL, and LOS between extracorporeal and intracorporeal groups demonstrated no significant differences. For all patients, average OT was 141.6 ± 25.8 (range 86-192) min, average EBL was 59.5 ± 83.3 (range 0-500) mL, and average LOS was 3.4 ± 1.19 (range 1.5-8) days. Four patients required conversion, all of which occurred in the extracorporeal group. There were no conversions after the 18th procedure. The 60-day mortality rate was 0%. There were no anastomotic leaks, ostomies created, or readmissions. As the surgeon gained experience, a statistically significant increase in lymph node sampling was observed in oncologic cases (p = .02). CONCLUSIONS: The robotic platform may help more surgeons safely and efficiently transition to a purely minimally invasive procedure, enabling more patients to reap the benefits of less invasive surgery. Transitioning from ECA to ICA during robotic right colectomy resulted in no significant change in OT or LOS. A lower rate of conversion to open surgery was noted with increased experience.

Horseshoe abscesses and fistulas: how are we doing?

BACKGROUND: Various surgical treatments exist for horseshoe abscesses and fistulae, including posterior midline sphincterotomy, catheter drainage, cutting and draining setons, and advancement flaps. The aim of this study was to evaluate the long-term results of patients treated for these complex anorectal problems. METHODS: A retrospective review was undertaken of patients with a diagnosis of horseshoe abscess, horseshoe fistula, postanal space abscess, or postanal space fistula from 1990 to 2001. Long-term follow-up was accomplished by telephone questionnaire. RESULTS: Thirty-one patients were identified, of whom 17 (54.8%) had a diagnosis of Crohn disease. The diagnosis at presentation included unilateral (ischiorectal) abscess (32.3%), bilateral horseshoe abscess (51.6%), bilateral horseshoe fistula (9.7%), and postanal space abscess (6.4%). Endoanal ultrasonography was used during the preoperative evaluation in 11 patients (35.5%). After referral to our institution, patients underwent a median of four operations (range, 1 to 9). At a mean follow-up of 49.3 months, 60.7% of patients had either healed perineal disease or were asymptomatic with controlled disease. Patients who had a posterior midline sphincterotomy were more likely to be asymptomatic (P=.047). Patients who had a diagnosis of Crohn disease required more operations than those without Crohn disease (3 vs 1.86, P=.02). Only patients who had a diagnosis of Crohn disease had a stoma at their last follow-up (4 of 17, 23.5% vs 0 of 11, 0%; P=.05). CONCLUSIONS: Patients with horseshoe abscess or fistulae often require multiple operations for treatment but can expect reasonable rates of long-term success in controlling or curing their disease. Those who undergo posterior midline sphincterotomy seem to benefit with higher rates of improved symptoms. Patients with a diagnosis of Crohn disease may fare less well. The role of endoanal ultrasonography in directing therapy remains to be defined.

Do patients followed in anticoagulation clinics for antiphospholipid syndrome meet criteria for the disorder?

Although specific criteria for diagnosing the antiphospholipid syndrome (APS) exist (the Sapporo Criteria), most physicians are not aware these include repeat testing and documentation of either a lupus anticoagulant or medium to high levels of anti-cardiolipin antibody. Incorrect diagnosis of APS may result in unnecessary long-term anticoagulation. The purpose of this study was to determine the clinical and serological characteristics of patients being treated for APS and concordance with published criteria. This cross-sectional study identified APS patients who were being treated with warfarin at one of three university-based anticoagulation clinics. Levels of anticardiolipin antibody were classified as low-positive if abnormal but < 40 GPL/MPL units and medium/high-positive if > or = 40 units. Strength of meeting Sapporo criteria was graded as definite, possible, and not meeting criteria. Of 103 cases, 97 had clinical and laboratory data available. Only 10 cases (10%, 95% Confidence Interval 5 - 19) met criteria for definite APS, 16 (16%, 10 - 26) had a possible diagnosis, and 71 (73%, 63 - 81) did not meet criteria. Of 70 cases that had abnormal anticardiolipin antibody results, only 32 (46%, 34 - 58) had medium/high-positive levels. Repeat laboratory testing was performed in only 49 cases (51%, 40 - 61). We conclude that few patients treated forAPS met Sapporo criteria. Abnormal levels of anticardiolipin antibody were frequently in the low-positive range, and repeat testing was often absent. A quality improvement program that includes review of cases referred for chronic anticoagulation care is recommended to ensure appropriate testing and treatment of patients with suspected APS.