Hemorrhoid Banding: A Cost-Effectiveness Analysis.

BACKGROUND: Hemorrhoid banding is an established treatment for symptomatic internal hemorrhoids with proven efficacy, low cost, and limited discomfort. Although the costs and quality of life following individual banding treatments have been investigated, little is known about cumulative cost and quality of life from sequential banding therapy or how these cumulative costs compare to surgical therapy. OBJECTIVE: This study aimed to determine the cost-effectiveness of sequential hemorrhoid banding therapy. DESIGN: A retrospective review of historic banding treatment patterns was performed. Cost estimates and quality-of-life predictions were applied to observed treatment patterns in a decision-analytic cost-effectiveness model to compare sequential banding therapy with hypothetical surgical intervention. SETTING: A retrospective billing record review for patients treated in a colorectal specialty clinic between 2012 and 2017 was performed. PATIENTS: Patients initially treated with banding therapy for symptomatic internal hemorrhoids were included. MAIN OUTCOME MEASURE: The primary outcomes measured were hemorrhoid banding treatment patterns, cost-effectiveness, and net monetary benefit. RESULTS: Treatment of 2026 patients undergoing hemorrhoid banding identified 94% resolution with sequential banding and 6% requiring delayed surgical intervention. Average cumulative estimated cost for banding therapy was $723 (range, $382-$4430) per patient with an average quality-of-life deficit of -0.00234 (range, -0.00064 to -0.02638) quality-adjusted life-years. Estimates for hypothetical hemorrhoid artery ligation, stapled hemorrhoidopexy, or surgical hemorrhoidectomy found significantly higher cost (3.15×, 4.39×, and 2.75× more expensive) and a significantly worse quality-of-life deficit (1.55×, 5.64×, and 9.45× worse). For patients with persistent disease, continued sequential banding remained the dominant cost-effective therapy. LIMITATIONS: This cost-effectiveness model relies on a retrospective review of billing records with estimated cost and quality of life. CONCLUSIONS: Hemorrhoid banding is a valuable treatment modality with favorable cost-effectiveness. The majority of patients selected for banding find resolution without surgery. For patients with persistent disease, further banding procedures remain cost-effective compared with delayed surgical therapy. See Video Abstract at http://links.lww.com/DCR/A982. BANDA HEMORROIDAL: UN ANÁLISIS DE COSTO-EFECTIVIDAD: La banda para hemorroides es un tratamiento establecido para las hemorroides internas sintomáticas con eficacia comprobada, bajo costo y malestar limitado. Si bien se han investigado los costos y la calidad de vida después de los tratamientos de bandas individuales, se sabe poco sobre el costo acumulativo y la calidad de vida de la terapia de bandas secuencial o cómo estos costos acumulativos se comparan con la terapia quirúrgica. OBJETIVO: Determinar el costo-efectividad de la terapia secuencial de bandas hemorroidales. DISEÑO:: Se realizó una revisión retrospectiva de la historia de los patrones de tratamiento con bandas. Las estimaciones de costos y las predicciones de la calidad de vida se aplicaron a los patrones de tratamiento observados en un modelo analítico de costo-efectividad para comparar la terapia de bandas secuencial con la intervención quirúrgica hipotética. AJUSTE: Revisión retrospectiva de los registros de facturación de los pacientes tratados en una clínica de especialidad colorrectal entre 2012 y 2017. PACIENTES: Pacientes tratados inicialmente con terapia de bandas para hemorroides internas sintomáticas. PRINCIPALES MEDIDAS DE RESULTADO: Patrones de tratamiento con bandas de hemorroides, costo-efectividad y beneficio monetario neto. RESULTADOS: El tratamiento de 2026 pacientes con bandas identificó una resolución del 94% con bandas secuenciales y el 6% requirió una intervención quirúrgica tardía. El costo promedio acumulado estimado para la terapia de banda fue de $ 723 (Rango: $382-$4430) por paciente con un déficit de calidad de vida promedio de -0.00234 (Rango: -0.00064 a -0.02638) años de vida ajustados por calidad. Las estimaciones para la hipotética ligadura de la arteria hemorroidal, la hemorroidopexia con grapas o la hemorroidectomía quirúrgica encontraron un costo significativamente mayor (3.15×, 4.39×, 2.75× más caro) y un déficit de la calidad de vida significativamente peor (1.55×, 5.64×, 9.45× peor). Para los pacientes con enfermedad persistente, la colocación de bandas secuenciales continuas siguió siendo la terapia rentable dominante. LIMITACIONES: Este modelo de costo-efectividad se basa en una revisión retrospectiva de los registros de facturación con el costo y la calidad de vida estimados. CONCLUSIONES: Las bandas de hemorroides son una valiosa modalidad de tratamiento con una favorable relación costo-efectividad. La mayoría de los pacientes seleccionados para terapia con bandas encuentran resolución sin cirugía. Para los pacientes con enfermedad persistente, los procedimientos de colocación de bandas adicionales siguen siendo rentables en comparación con el tratamiento quirúrgico tardío. Vea el Resumen del video en http://links.lww.com/DCR/A982.

Cost-Effectiveness Analysis of Total Neoadjuvant Therapy Followed by Radical Resection Versus Conventional Therapy for Locally Advanced Rectal Cancer.

BACKGROUND: Definitive surgery with total mesorectal excision is the mainstay of treatment for locally advanced rectal cancer. Multimodality therapy improves long-term survival. Current standards advise neoadjuvant chemoradiation followed by radical surgery and adjuvant chemotherapy. Nationally, compliance with adjuvant chemotherapy is only 32%. New research evaluates the effectiveness of total neoadjuvant therapy: complete chemotherapy and chemoradiation before surgery. OBJECTIVE: The aim of this study is to determine the favored treatment for locally advanced rectal cancer by comparing the cost-effectiveness of total neoadjuvant therapy and the current standard of care. DESIGN: Decision analytical modeling using long-term costs and 5-year disease-free survival was performed to determine the cost-effectiveness after total neoadjuvant therapy and the current standard of care. Sensitivity analysis was used to investigate the effect of uncertainty in model parameters. SETTINGS: Centers for Medicare & Medicaid Services billing data perspective was adopted and outcomes modeled according to local and national databases and literature consensus. PATIENTS: Adult patients with stage II or III rectal cancer were selected. MAIN OUTCOME MEASURES: Cost-effectiveness in disease-free life-years, incremental cost-effectiveness ratio, and net monetary benefit were determined over a 5-year posttreatment period. The favored strategy was determined based on cost-effectiveness and sensitivity analyses. RESULTS: Cost-effectiveness for total neoadjuvant therapy was 40,708 $/life-year, and, for conventional therapy, cost-effectiveness was 44,248 $/life-year. Sensitivity analysis showed that, for an estimated total neoadjuvant therapy completion rate of 90%, total neoadjuvant therapy would remain the dominant strategy for any adjuvant chemotherapy completion rate of less than 93%. LIMITATIONS: The samples used to calculate completion rates are small, and survival probabilities are based on existing literature, local database values, and consensus estimates. The model encompasses a 5-year time period from diagnosis. CONCLUSIONS: Cost-effectiveness analysis shows that a strategy of total neoadjuvant therapy followed by radical surgery is favored over the current standard of care for locally advanced rectal cancer. Sensitivity analysis shows that a low rate of adjuvant chemotherapy administration plays a key role in decreasing the cost-effectiveness of the current standard of care. See Video Abstract at http://links.lww.com/DCR/A942.

New American Cancer Society process for creating trustworthy cancer screening guidelines.

Guidelines for cancer screening written by different organizations often differ, even when they are based on the same evidence. Those dissimilarities can create confusion among health care professionals, the general public, and policy makers. The Institute of Medicine (IOM) recently released 2 reports to establish new standards for developing more trustworthy clinical practice guidelines and conducting systematic evidence reviews that serve as their basis. Because the American Cancer Society (ACS) is an important source of guidance about cancer screening for both health care practitioners and the general public, it has revised its methods to create a more transparent, consistent, and rigorous process for developing and communicating guidelines. The new ACS methods align with the IOM principles for trustworthy clinical guideline development by creating a single generalist group for writing the guidelines, commissioning independent systematic evidence reviews, and clearly articulating the benefits, limitations, and harms associated with a screening test. This new process should ensure that ACS cancer screening guidelines will continue to be a trustworthy source of information for both health care practitioners and the general public to guide clinical practice, personal choice, and public policy about cancer screening.

Age and rural residence effects on accessing colorectal cancer treatments: a registry study.

OBJECTIVES: To test the hypotheses that older patients with colorectal cancer (CRC) and rural patients are less likely to undergo surgery, radiation, and chemotherapy. STUDY DESIGN: Retrospective study. METHODS: A total of 6561 patients with CRC between January 1998 and December 2003 were identified by incident International Classification of Diseases for Oncology codes from the Nebraska Cancer Registry. In multivariate logistic regression analyses, we studied the association of age and residence county (rural vs urban and micropolitan) with each of 3 CRC treatments by anatomic site. RESULTS: After adjusting for patient demographics, insurance payer, ratio of providers to population, and cancer stage, patients with colon cancer living in micropolitan counties were more likely to receive chemotherapy than those living in rural counties (P <.001). Compared with patients aged 19 to 64 years, patients with colon cancer 85 years and older (P <.001) and patients with rectal cancer 75 years and older (P <.05) were less likely to undergo surgery. Patients with CRC 75 years and older were less likely to receive radiation, and patients with colon cancer 65 years and older and patients with rectal cancer 75 years and older were less likely to receive chemotherapy (P <.001 for both). CONCLUSIONS: In Nebraska, older patients with CRC were less likely to undergo surgery, radiation, and chemotherapy. Patients with colon cancer in rural counties were less likely to undergo chemotherapy than those in micropolitan counties. Decision makers need to consider issues of age and rural residence in patient access to CRC treatments.

Current neoadjuvant strategies in rectal cancer.

Treatment modalities in rectal cancer have undergone a slow, evolutionary transition over the past 30 years. More recently, contemporary descriptions of advanced preoperative chemotherapy and radiation schema have led to a rapid revolution in the management of this disease. In this review we focus on current evidence-based neoadjuvant strategies used in the treatment of locally advanced rectal cancer and metastatic rectal disease. Finally, we provide a foundation for discussion of still unresolved issues.

Permanent diversion rates after neoadjuvant therapy and coloanal anastomosis for rectal cancer.

BACKGROUND: The aim of this study was to assess the rate of permanent diversion in patients undergoing coloanal anastomosis after neoadjuvant therapy for rectal cancer. METHODS: We performed a retrospective review of patients with rectal cancer who underwent a total mesorectal excision of a tumor within 9 cm of the anal verge. RESULTS: There were 201 patients who underwent resection with coloanal anastomosis, with a mean follow-up period of 51 months. The average tumor distance from the anal verge was 7 cm (range, 4-9 cm). Neoadjuvant therapy was administrated in 145 patients, 47 had no radiation, and 9 received radiation postoperatively. Thirty-two patients (16%) had long-term complications including incontinence, fistulas, and strictures. Twenty-five patients (12%) had recurrent disease, 16 of these were local recurrence. The total rate of permanent diversion was 29 (14%). Reasons for diversion included local recurrence in 12 patients (6%), complications in 10 patients (5%), and poor function in 7 patients (3%). CONCLUSIONS: Poor bowel function, late complications, and local recurrence all contribute to permanent diversion after a coloanal anastomosis. Neoadjuvant therapy in conjunction with a total mesorectal excision and coloanal anastomosis leads to acceptably low permanent diversion rates in the vast majority of patients.

Colorectal cancer screening.

Colorectal cancer (CRC) constitutes the second leading cause of death from cancer in the United States. Increased screening for CRC have been associated with a decreased incidence in the past two decades. Continued efforts are necessary to maintain this trend. Appropriate risk stratification of individuals and compliance with recommended screening strategies are important. Colonoscopy continues to play an important role in screening; however, several different screening options are available for average-risk individuals. This article reviews the current options open to physicians to adequately screen patients for CRC based on inherit risks.

Rurality and other determinants of early colorectal cancer diagnosis in Nebraska: a 6-year cancer registry study, 1998-2003.

BACKGROUND: There are no studies of rurality, and other determinants of colorectal cancer (CRC) stage at diagnosis with population-based data from the Midwest. METHODS: This retrospective study identified, incident CRC patients, aged 19 years and older, from 1998-2003 Nebraska Cancer Registry (NCR) data. Using federal Office of Management and Budget classifications, we grouped patients by residence in metropolitan, micropolitan nonmetropolitan, or rural nonmetropolitan counties (non-core based statistical areas). In univariate and multivariate logistic regression analyses, we examined the association of the county classification and of other determinants with early (in situ/local) versus late (regional/distant) stage at CRC diagnosis. RESULTS: Of the 6,561 CRC patients identified, 45% were from metropolitan counties, 24% from micropolitan nonmetropolitan counties and 31% from rural nonmetropolitan counties, with 32%, 38%, and 33%, respectively, being diagnosed at an early stage. Multivariate analysis showed micropolitan nonmetropolitan residents were significantly more likely than rural nonmetropolitan residents to be diagnosed at an early stage (adjusted OR, 1.22; 95% CI: 1.05-1.42, P < .05). However, rural nonmetropolitan and metropolitan residents did not significantly differ in the likelihood of early diagnosis. Residents with Medicare rather than those with private insurance (P < .0001), married rather than unmarried residents (P < .01), and residents with rectal cancer rather than those with colon cancer (P < .0001) were more likely to be diagnosed at an early stage. CONCLUSIONS: Early CRC diagnosis needs to be increased in rural (non-core) non-metropolitan residents, unmarried residents, and those with private insurance.

Clinical outcomes of complicated diverticulitis managed nonoperatively.

BACKGROUND: Surgical resection is typically recommended for patients with computed tomography (CT)-confirmed complicated diverticulitis. This study was designed to assess outcomes of patients with complicated diverticulitis managed nonoperatively. METHODS: A retrospective study covering 14 years evaluated patients with complicated diverticulitis diagnosed by CT scan. Patient outcomes, including recurrence and need for operations, were reviewed. RESULTS: Of 256 patients identified, 99 were managed nonoperatively. Forty-six of the 99 patients had a recurrent episode of diverticulitis. Of these 46 patients, 20 underwent a sigmoid colon resection, with only 1 patient requiring a colostomy for obstruction. None of these recurrences resulted in the need for emergency resection. CONCLUSIONS: Surgical treatment should play an important role in the management of patients with complicated diverticulitis because of the high risk of recurrence. However, nonoperative management may be appropriate in a select population if age or medical comorbidities preclude a safe operation since the need for emergency operation is unlikely.

Risk of late bleeding following hemorrhoidal banding in patients on antithrombotic prophylaxis.

BACKGROUND: The risk of bleeding following rubber band ligation of internal hemorrhoids is 1%-2%. This risk may be increased in patients taking antithrombotic therapy. The goal of the current study was to find a safer approach to banding without increasing the risk of bleeding. METHODS: This retrospective review identified patients undergoing banding while on antithrombotic therapy. These medications were held for 7-10 days following the procedure. The number of bands placed while on antithrombotic therapy and their post band complications were recorded. RESULTS: There were 605 bands placed on 364 patients taking antithrombotic medications. There were 23 complications involving bleeding, a value that was not statistically different from those not taking antithrombotic therapy. Patients on clopidogrel experienced 50% of the significant bleeding episodes and 18% of the insignificant bleeding episodes. CONCLUSIONS: Holding antithrombotic medication following banding appears to equalize the risk of bleeding to that of patients not taking antithrombotic medications. Patients taking clopidogrel may be at higher risk for bleeding complications.

Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer.

OBJECTIVE: To test the hypothesis that surgeon volume would not predict short- and long-term outcomes when evaluated in the setting of technical credentialing. SUMMARY BACKGROUND DATA: Surgical volume is a known predictor of outcomes; the importance of technical credentialing has not been evaluated. METHODS: Fifty-three credentialed surgeons operated on 871 patients in the Clinical Outcomes of Surgical Therapy Study (NCT00002575), investigating laparoscopic versus open surgery for colon cancer. Credentialing required that each surgeon document performance of at least 20 laparoscopic colon cases and demonstrate oncologic techniques on a video-recorded case. Surgeons were separated based on volume entered into the trial (low, < or =5 cases (n = 39); medium, 6-10 cases (n = 9); or high, >10 cases (n = 5)) and compared by outcomes. RESULTS: Patients treated by high volume compared with medium or low volume surgeons were older (70, 66, and 68 years; P < 0.001), more often had right-sided tumors (63%, 46%, and 53%; P < 0.001) and had more previous operations (48%, 38% and 45%; P < 0.004), respectively. Mean operative times were shorter (123, 147 and 145 minutes; P < 0.001), distal margins longer (13.4, 12.4 and 11.6 cm; P = 0.005), and lymph node harvest greater (14.8, 12.8, 12.6; P = 0.05) for high versus medium versus low volume surgeons. However, rates of conversion, complications, 5-year survival, and disease-free survival showed no significant differences. CONCLUSION: When tested in a randomized controlled trial with case-specific surgical technical credentialing and auditing, surgeon volume did not predict differences in rates of conversion, complications, or long-term cancer outcomes. Case-specific technical credentialing should be further studied specific to the role it could play in creating consistent, high quality outcomes.

Familial adenomatous polyposis in children younger than age ten years: a multidisciplinary clinic experience.

PURPOSE: Children with familial adenomatous polyposis have a greater mortality and morbidity in the first decade of life compared with the general population. Some children with a more severe disease phenotype present early with colorectal adenomata and may require colectomy at an early age. We present our multidisciplinary clinic experience with familial adenomatous polyposis in children younger than age ten years at the time of presentation. METHODS: A cross-sectional analysis was performed on all patients with suspected or confirmed familial adenomatous polyposis presenting in the first decade of life and followed by the multidisciplinary Pediatric Hereditary Polyposis Clinic at our institutions. Analysis included demographics, clinical presentation and course, gene mutation testing, endoscopic-histologic findings, and surgical outcome. RESULTS: Twenty-two children (11 males) presented with suspected or confirmed familial adenomatous polyposis. Two were discharged from follow-up after negative adenomatous polyposis coli gene mutation testing. The rest underwent annual hepatoblastoma surveillance through age ten years with negative findings. Twelve patients presented with symptoms: six had de novo familial adenomatous polyposis. Seven had gastrointestinal hemorrhage and went on to colonoscopy. Four patients with adenomatous polyposis coli gene mutation at codon 1309 were referred for colectomy before age ten years. Referral to colectomy was earlier in patients with 1309 mutation and with de novo familial adenomatous polyposis. CONCLUSIONS: Children with familial adenomatous polyposis younger than age ten years may present presymptomatically for disease surveillance. Familial adenomatous polyposis with adenomatous polyposis coli gene mutation at codon 1309 entails a risk of a more aggressive phenotype; early colectomy may be indicated in children harboring this gene mutation.

A midpoint assessment of the American Cancer Society challenge goal to decrease cancer incidence by 25% between 1992 and 2015.

In 1998, the American Cancer Society (ACS) set a challenge goal for the nation to reduce cancer incidence by 25% over the period between 1992 and 2015. This report examines the trends in cancer incidence between 1992 and 2004. Trends were calculated using data on incident malignant cancer cases from the Surveillance, Epidemiology, and End Results (SEER) Registry. Delay-adjusted incidence trends for all cancer sites; all cancer sites without prostate cancer included; all cancer sites stratified by gender, age, and race; and for 20 selected cancer sites are presented. Over the first half of the ACS challenge period, overall cancer incidence rates have declined by about 0.6% per year. The greatest overall declines were observed among men and among those aged 65 years and older. The pace of incidence reduction over the first half of the ACS challenge period was only half that necessary to put us on target to achieve the 25% cancer incidence reduction goal in 2015. New understandings of preventable factors are needed, and new efforts are also needed to better act on our current knowledge about how we can prevent cancer, especially by continuing to reduce tobacco use and beginning to reverse the epidemic of obesity.

Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and US Multi-Society Task Force on Colorectal Cancer.

Patients with resected colorectal cancer are at risk for recurrent cancer and metachronous neoplasms in the colon. This joint update of guidelines by the American Cancer Society (ACS) and US Multi-Society Task Force on Colorectal Cancer addresses only the use of endoscopy in the surveillance of these patients. Patients with endoscopically resected Stage I colorectal cancer, surgically resected Stage II and III cancers, and Stage IV cancer resected for cure (isolated hepatic or pulmonary metastasis) are candidates for endoscopic surveillance. The colorectum should be carefully cleared of synchronous neoplasia in the perioperative period. In nonobstructed colons, colonoscopy should be performed preoperatively. In obstructed colons, double contrast barium enema or computed tomography colonography should be done preoperatively, and colonoscopy should be performed 3 to 6 months after surgery. These steps complete the process of clearing synchronous disease. After clearing for synchronous disease, another colonoscopy should be performed in 1 year to look for metachronous lesions. This recommendation is based on reports of a high incidence of apparently metachronous second cancers in the first 2 years after resection. If the examination at 1 year is normal, then the interval before the next subsequent examination should be 3 years. If that colonoscopy is normal, then the interval before the next subsequent examination should be 5 years. Shorter intervals may be indicated by associated adenoma findings (see Postpolypectomy Surveillance Guideline). Shorter intervals are also indicated if the patient's age, family history, or tumor testing indicate definite or probable hereditary nonpolyposis colorectal cancer. Patients undergoing low anterior resection of rectal cancer generally have higher rates of local cancer recurrence, compared with those with colon cancer. Although effectiveness is not proven, performance of endoscopic ultrasound or flexible sigmoidoscopy at 3- to 6-month intervals for the first 2 years after resection can be considered for the purpose of detecting a surgically curable recurrence of the original rectal cancer.

Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer.

Patients with resected colorectal cancer are at risk for recurrent cancer and metachronous neoplasms in the colon. This joint update of guidelines by the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer addresses only the use of endoscopy in the surveillance of these patients. Patients with endoscopically resected Stage I colorectal cancer, surgically resected Stages II and III cancers, and Stage IV cancer resected for cure (isolated hepatic or pulmonary metastasis) are candidates for endoscopic surveillance. The colorectum should be carefully cleared of synchronous neoplasia in the perioperative period. In nonobstructed colons, colonoscopy should be performed preoperatively. In obstructed colons, double-contrast barium enema or computed tomography colonography should be performed preoperatively, and colonoscopy should be performed 3 to 6 months after surgery. These steps complete the process of clearing synchronous disease. After clearing for synchronous disease, another colonoscopy should be performed in 1 year to look for metachronous lesions. This recommendation is based on reports of a high incidence of apparently metachronous second cancers in the first 2 years after resection. If the examination at 1 year is normal, then the interval before the next subsequent examination should be 3 years. If that examination is normal, then the interval before the next subsequent examination should be 5 years. Shorter intervals may be indicated by associated adenoma findings (see "Guidelines for Colonoscopy Surveillance After Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society"). Shorter intervals also are indicated if the patient's age, family history, or tumor testing indicate definite or probable hereditary nonpolyposis colorectal cancer. Patients undergoing low anterior resection of rectal cancer generally have higher rates of local cancer recurrence compared with those with colon cancer. Although effectiveness is not proven, performance of endoscopic ultrasound or flexible sigmoidoscopy at 3- to 6-month intervals for the first 2 years after resection can be considered for the purpose of detecting a surgically curable recurrence of the original rectal cancer.

Response to preoperative chemoradiation in stage II and III rectal cancer.

PURPOSE: The purpose of this study was to determine whether a complete pathologic response after neoadjuvant therapy in rectal cancer patients improves disease control and survival. METHODS: The study reviewed Stage II and III rectal cancer patients treated with preoperative chemoradiation and resected for cure. Complete pathologic response was defined as no cancer in the resected specimen. The main outcome measures were cancer-specific and disease-free survival in patients achieving a complete pathologic response and a noncomplete pathologic response. Kaplan-Meier curves were evaluated using log-rank analysis. RESULTS: Eighty-nine rectal cancer patients received neoadjuvant chemoradiation followed by radical resection for cure. Twenty-one patients (24 percent) achieved a complete pathologic response. Median follow-up for the complete pathologic response group was 23.5 months and 31 months for the noncomplete pathologic response group. There were more Stage III patients in the noncomplete pathologic response group than the complete pathologic response group (P = 0.005). Complete pathologic response patients were less likely to receive postoperative adjuvant chemotherapy than noncomplete pathologic response patients (P = 0.004). Cancer-specific and disease-free survival were not statistically different between the two groups. However, a trend was noted toward improved survival and decreased recurrence in association with a complete pathologic response. CONCLUSION: Stage III patients were less likely to be in the complete pathologic response group than Stage II patients. Complete pathologic response patients were less likely to receive postoperative adjuvant chemotherapy than noncomplete pathologic response patients. Complete pathologic response after neoadjuvant chemoradiation for rectal cancer patients demonstrated a trend toward improved survival and decreased recurrence compared with noncomplete pathologic response patients.

Long-term efficacy of dynamic graciloplasty for fecal incontinence.

PURPOSE: Patients with end-stage fecal incontinence in whom all standard medical and surgical treatment has failed or is not expected to be effective can be treated by dynamic graciloplasty. The aim of this study was to review the long-term efficacy data. METHODS: Success was defined as a greater than 50 percent decrease in the frequency of incontinent episodes. Measured physiologic parameters included enema retention time and the difference in resting and squeezing pressures with and without stimulation. Measured quality-of-life parameters included the Medical Outcomes Study Short Form 36 Health Status Questionnaire, a Fecal Incontinence TyPE Specification, the Zung Self-Rating Depression Scale, the "state" portion of the State-Trait Anxiety Inventory, and the Visual Analog Scale, which were administered at baseline and through follow-up. Independent monitors collected data as part of a multicenter trial for patients who underwent dynamic graciloplasty from May 1993 to November 1999. RESULTS: There were 129 patients entered in the study, 115 of whom met eligibility criteria and were included in the efficacy outcome analysis. Twenty-seven patients entered the study with a preexisting functioning stoma; the remaining 88 patients did not have a functioning stoma at the time of enrollment. Success was achieved in 62 percent of nonstoma patients at 12 months; these results were sustained at 18-month and 24-month follow-up assessments (55 and 56 percent, respectively). The success rate in the stoma patients increased from 37.5 percent (9 of 24 patients) at 12 months to 62 percent (13 of 21 patients) at 18 months and was 43 percent at 24 months (9 of 21 patients), which reflects the increased number of patients whose stomas were closed. Although the measured physiologic continence parameters generally improved, these changes did not correlate with continence outcome. The group of patients (stoma and nonstoma) who underwent dynamic graciloplasty showed statistically significant improvements in quality of life as measured by Medical Outcomes Study Short Form 36 physical function (P = 0.006) and social functioning (P = 0.02) assessment. CONCLUSIONS: Dynamic graciloplasty was successful in the majority of patients with end-stage fecal incontinence. This result was usually achieved by 12 months after surgery in patients who did not have stomas and by 18 months in patients who had stomas at the time of dynamic graciloplasty surgery. These various improvements conferred by dynamic graciloplasty persisted during the two-year follow-up.

Anorectal physiology.

Anorectal physiology, as assessed in an ARP laboratory, can provide helpful information in the management of patients with constipation and bowel incontinence. Beyond the uses described in this review, however, the ARP laboratory is most useful in the research setting. In this setting the laboratory can expand our understanding of function associated with other disease states, including anal fissure, fistula-in-ano, inflammatory bowel disease, and postoperative states. The lab can also provide improved understanding of the complex interactions of the enteric nervous and gut hormone systems with the smooth and skeletal muscle systems. A part of the failure of the ARP laboratory to enjoy more clinical usefulness lies in a lack of standardization of test protocols for many of the tests. Secondarily, there is a lack of normative data from large numbers of normal patients [1]. Finally, there is the difficulty in reproducing tests in situations where the patient has significant potential to compensate for deficits through the recruitment of adjacent muscle groups and other maneuvers. There is also some reluctance on the part of clinicians to make use of the ARP laboratory if the testing is not readily available in their community. Although the tests themselves are not difficult to learn to administer, lack of familiarity with the testing process can act as a barrier to acceptance. This is particularly true for clinicians that are used to making clinical decisions without the added benefit of physiologic testing. Despite these obstacles, the role of the ARP laboratory in the management of complex anorectal disease is likely to grow in the years ahead.