Organ Preservation and Survival by Clinical Response Grade in Patients With Rectal Cancer Treated With Total Neoadjuvant Therapy: A Secondary Analysis of the OPRA Randomized Clinical Trial.

Importance: Assessing clinical tumor response following completion of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer is paramount to select patients for watch-and-wait treatment. Objective: To assess organ preservation (OP) and oncologic outcomes according to clinical tumor response grade. Design, Setting, and Participants: This was secondary analysis of the Organ Preservation in Patients with Rectal Adenocarcinoma trial, a phase 2, nonblinded, multicenter, randomized clinical trial. Randomization occurred between April 2014 and March 2020. Eligible participants included patients with stage II or III rectal adenocarcinoma. Data analysis occurred from March 2022 to July 2023. Intervention: Patients were randomized to induction chemotherapy followed by chemoradiation or chemoradiation followed by consolidation chemotherapy. Tumor response was assessed 8 (±4) weeks after TNT by digital rectal examination and endoscopy and categorized by clinical tumor response grade. A 3-tier grading schema that stratifies clinical tumor response into clinical complete response (CCR), near complete response (NCR), and incomplete clinical response (ICR) was devised to maximize patient eligibility for OP. Main Outcomes and Measures: OP and survival rates by clinical tumor response grade were analyzed using the Kaplan-Meier method and log-rank test. Results: There were 304 eligible patients, including 125 patients with a CCR (median [IQR] age, 60.6 [50.4-68.0] years; 76 male [60.8%]), 114 with an NCR (median [IQR] age, 57.6 [49.1-67.9] years; 80 male [70.2%]), and 65 with an ICR (median [IQR] age, 55.5 [47.7-64.2] years; 41 male [63.1%]) based on endoscopic imaging. Age, sex, tumor distance from the anal verge, pathological tumor classification, and clinical nodal classification were similar among the clinical tumor response grades. Median (IQR) follow-up for patients with OP was 4.09 (2.99-4.93) years. The 3-year probability of OP was 77% (95% CI, 70%-85%) for patients with a CCR and 40% (95% CI, 32%-51%) for patients with an NCR (P < .001). Clinical tumor response grade was associated with disease-free survival, local recurrence-free survival, distant metastasis-free survival, and overall survival. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, most patients with a CCR after TNT achieved OP, with few developing tumor regrowth. Although the probability of tumor regrowth was higher for patients with an NCR compared with patients with a CCR, a significant proportion of patients achieved OP. These findings suggest the 3-tier grading schema can be used to estimate recurrence and survival outcomes in patients with locally advanced rectal cancer who receive TNT. Trial Registration: ClinicalTrials.gov Identifier: NCT02008656.

Cost Drivers of Elective Colon and Rectal Surgery: A Retrospective Cohort Analysis.

BACKGROUND: Colorectal surgery is expensive. Few studies have evaluated complications as an economic cost driver, and there is little evidence comparing multiple cost drivers of colorectal surgery to determine the most effective means of reducing total cost. OBJECTIVE: This study aimed to determine the effects of surgical techniques, use of enhanced recovery protocols, and presence or absence of complications on the total cost of hospitalization for elective colorectal surgery. DESIGN: A retrospective cohort analysis using data from 2011 to 2018 was performed. The primary end point was a mean cost per hospitalization. The cost was compared between patients who experienced minimally invasive versus open surgeries, enhanced recovery after surgery protocols versus not, and complications versus none. SETTINGS: This study was conducted at a university-affiliated teaching hospital in the Northeastern United States. PATIENTS: Adult patients who have undergone elective colorectal surgery were included. MAIN OUTCOME MEASURES: The primary outcome for this study was the mean cost per hospitalization calculated using inpatient cost based on the total cost of the episode of care. RESULTS: A total of 1039 patients met the criteria for inclusion. The average cost of all hospitalizations was $19,801. Multivariate analysis demonstrated that enhanced recovery protocols substantially lowered the cost of care by $6392 ( p = 0.001), whereas complications increased the cost of care by $16,780 per episode ( p < 0.001). When complications occurred, enhanced recovery protocols reduced the cost by $17,963 ( p = 0.010). LIMITATIONS: This retrospective cohort study performed at a single institution has inherent limitations, including confounding and selection bias. CONCLUSIONS: For elective colorectal surgery, complications are associated with significantly increased costs. Avoiding complications should be a priority to reduce costs. Enhanced recovery protocols are associated with significantly reduced costs. Surgeons should focus future research efforts on improving protocols and processes that decrease postoperative complications to improve patient outcomes and to reduce costs associated with elective colorectal hospitalizations. See Video Abstract at http://links.lww.com/DCR/B927 . FACTORES DE COSTO DE LA CIRUGA ELECTIVA DE COLON Y RECTO UN ANLISIS DE COHORTE RETROSPECTIVE: ANTECEDENTES:La cirugía colorrectal es costosa. Pocos estudios han examinado las complicaciones como un factor de costo económico, y hay poca evidencia que compare múltiples factores de costo de la cirugía colorrectal para determinar los medios más efectivos para reducir el costo total.OBJETIVO:Este estudio tiene como objetivo determinar los efectos de las técnicas quirúrgicas, el uso de protocolos de enhanced recovery y la presencia o ausencia de complicaciones en el costo total de hospitalización por cirugía colorrectal electiva.DISEÑO:Se realizó un análisis retrospectivo de cohortes utilizando data del 2011-2018. El punto principal fue el costo medio por hospitalización. Se comparó el costo entre los pacientes que experimentaron: cirugías mínimamente invasivas versus abiertas, protocolos de enhanced recovery después de la cirugía versus no, y complicaciones versus no.FUENTE DE DATOS:Se consultó la base de datos financiera y contable del hospital y el registro médico electrónico para la obtencion de datos.ENTORNO CLINICO:Este estudio se realizó en un hospital docente afiliado a una universidad en el noreste de los Estados Unidos.PACIENTES:Se incluyeron pacientes adultos sometidos a cirugía colorrectal electiva.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal de este estudio fue el costo medio por hospitalización calculado utilizando el costo de hospitalización basado en el costo total del episodio de atención.RESULTADOS:Un total de 1.039 pacientes cumplieron los criterios de inclusión. El costo promedio de todas las hospitalizaciones fue de $19801. El análisis multivariante demostró que los protocolos de enhanced recovery redujeron sustancialmente el costo de la atención en $6392 ( p = 0,001), mientras que las complicaciones aumentaron el costo en $16780 por episodio ( p < 0,001). Cuando ocurrieron complicaciones, los protocolos de enhanced recovery redujeron el costo en $17963 ( p = 0,010).LIMITACIONES:Este es un estudio de cohorte retrospectivo realizado en una sola institución y tiene limitaciones inherentes que incluyen confusión y sesgo de selección.CONCLUSIONES:Video Resumen en http://links.lww.com/DCR/B927 . (Traducción- Dr. Francisco M. Abarca-Rendon ).

The Potential for Overtreatment With Total Neoadjuvant Therapy (TNT): Consider One Local Therapy Instead.

With increased therapeutic options in rectal cancer, a central question has become how to tailor therapy to patient preferences to avoid both over and under treatment. Total Neoadjuvant Therapy (TNT), defined as delivering all planned chemotherapy and radiation therapy (RT) before surgery, was developed with the primary goal of improving overall survival through early elimination of micrometastatic disease. In this narrative review assessing patients with operable adenocarcinoma of the rectum, we sought to evaluate TNT versus alternative options with regard to both quality of life (QoL) and oncologic outcomes. Survey data of patient preferences reveal that an increased focus on QoL when discussing options is essential. While evidence favors TNT improving distant metastases-free survival, this has not yet translated to a clear OS benefit. The improved pathologic complete response rate with TNT compared to short course RT or chemoradiation alone suggests proceeding to surgery might result in overtreatment, lending support to a watch-and-wait option for patients with a goal for nonoperative management if a clinical complete response is achieved. Similarly, for select low-risk patients, surgery may be the only local therapy required allowing for safe omission of RT. In the treatment of rectal cancer, the future appears to be moving toward one local therapy. As an alternative to TNT, there is growing support for the concept we define herein as total definitive therapy instead: chemoradiation followed by consolidation chemotherapy, saving surgery only for incomplete responders rather than as part of the initial treatment plan. Also, selective use of RT should be considered for low-risk patients. By thoroughly assessing how these treatment de-escalation options compare to more traditional treatment algorithms, this narrative review provides guidance on how to honor patient preferences for QoL by avoiding treatments that might offer negligible benefits in oncologic outcomes.

Consolidation mFOLFOX6 Chemotherapy After Chemoradiotherapy Improves Survival in Patients With Locally Advanced Rectal Cancer: Final Results of a Multicenter Phase II Trial.

BACKGROUND: Adding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response. OBJECTIVE: The purpose of this study was to analyze disease-free and overall survival. DESIGN: This was a nonrandomized phase II trial. SETTINGS: The study was conducted at multiple institutions. PATIENTS: Four sequential study groups with stage II or III rectal cancer were included. INTERVENTION: All of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6. MAIN OUTCOME MEASURES: The trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study. RESULTS: Of 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004, <0.001, and 0.001). A secondary analysis including only patients who received ≥1 cycle of FOLFOX still showed differences in survival between study groups (p = 0.03). LIMITATIONS: The trial was not randomized and was not powered to show differences in survival. Survival data were not available for 19% of the patients. CONCLUSIONS: Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.

Patient Perceptions and Quality of Life After Colon and Rectal Surgery: What Do Patients Really Want?

BACKGROUND: Colorectal surgery outcomes must be accurately assessed and aligned with patient priorities. No study to date has investigated the patient's subjective assessment of outcomes most important to them during and following their surgical recovery. Although surgeons greatly value the benefits of laparoscopy, patient priorities remain understudied. OBJECTIVE: This study aimed to assess what aspects of patients' perioperative care and recovery they value most when queried in the postoperative period. DESIGN: This study is an exploratory cross-sectional investigation of a defined retrospective patient population. Enrollees were stratified into subcategories and analyzed, with statistical analysis performed via χ test and unpaired t test. SETTINGS: This study was conducted at a single academic medical center in New England. PATIENTS: Patients who underwent a colorectal surgical resection between 2009 and 2015 were selected. INTERVENTIONS: Patients within a preidentified population were asked to voluntarily complete a 32-item questionnaire regarding their surgical care. MAIN OUTCOME MEASURES: The primary outcomes measured were patient perioperative and postoperative quality of life and satisfaction on selected areas of functioning. RESULTS: Of 167 queried respondents, 92.2% were satisfied with their recovery. Factors considered most important included being cured of colorectal cancer (76%), not having a permanent stoma (78%), and avoiding complications (74%). Least important included length of stay (13%), utilization of laparoscopy (14%), and incision appearance and length (2%, 4%). LIMITATIONS: The study had a relatively low response rate, the study is susceptible to responder's bias, and there is temporal variability from surgery to questionnaire within the patient population. CONCLUSIONS: Overall, patients reported high satisfaction with their care. Most important priorities included being free of cancer, stoma, and surgical complications. In contrast, outcomes traditionally important to surgeons such as laparoscopy, incision appearance, and length of stay were deemed less important. This research helps elucidate the outcomes patients truly consider valuable, and surgeons should focus on these outcomes when making surgical decisions. See Video Abstract at http://links.lww.com/DCR/A596. See Visual Abstract at https://tinyurl.com/yb25xl66.

Preemptive Analgesia Decreases Pain Following Anorectal Surgery: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial.

BACKGROUND: Postoperative pain is a frequent cause for delayed discharge following outpatient procedures, including anorectal surgery. Both central and peripheral pain receptor sensitization are thought to contribute to postoperative pain. Blocking these receptors and preempting sensitization prevents hyperalgesia leading to lower pain medication requirements. Studies in the orthopedic, urologic, and gynecologic literature support this practice, but the use of preemptive analgesia in anorectal surgery is understudied. OBJECTIVE: This study aimed to evaluate the effectiveness of preemptive analgesia in decreasing postoperative pain. DESIGN: This is a randomized, double-blinded, placebo-controlled trial. SETTING: This study was conducted at the University of Vermont Medical Center, a tertiary care referral center in Burlington, Vermont. PATIENTS: Patients who were over 18 years of age, ASA Physical Status Classes I, II, or III, and undergoing surgery for anal fissure, fistula or condyloma or hemorrhoids were selected. INTERVENTIONS: Preoperative oral acetaminophen and gabapentin followed by intravenous ketamine and dexamethasone were given before incision compared with oral placebos. MAIN OUTCOME MEASURES: The primary outcomes measured were postoperative pain scores, percentage of patients utilizing breakthrough narcotics, and rates of side effects. RESULTS: Ninety patients were enrolled. Because of patient withdrawal, screen failures, and loss to follow-up, 61 patients were analyzed (30 in the preemptive analgesia group and 31 in the control group). Patients in the active group had significantly less pain in the postanesthesia care unit and at 8 hours postoperatively. Significantly fewer participants in the active group used narcotics in the postanesthesia care unit and at 8 hours postoperatively. Average pain scores were excellent for both groups. There was no difference in the number of medication-related side effects between the 2 groups. LIMITATIONS: This study was limited by the small sample size and excellent pain control in both groups. CONCLUSIONS: Preemptive analgesia is safe and results in decreased pain in the early postoperative period following anorectal surgery. It should be implemented by surgeons performing these procedures. See Video Abstract at http://links.lww.com/DCR/A588.

Technical Considerations in Stoma Creation.

Creating an intestinal stoma is commonly the final aspect of an often emergent and complicated operation under difficult circumstances. While creation of a protruding, tension-free, and well-vascularized stoma is often straightforward, one must be prepared for challenging situations such as a thick abdominal wall and short, thickened mesentery. A successful stoma starts with attentive preoperative planning including site marking, thoughtful consideration of alternatives, and attention to technical detail. The tips provided in this article should facilitate the process of selecting the appropriate intestinal segment, identifying the correct stoma site, and creating a functional stoma even in the most challenging situations. Constructing a high-quality stoma will decrease complications and improve the patient's quality of life. Stoma creation is frequently the only component of an operation that the patient will have to live with for the remainder of his/her life.

Transanal Endoscopic Microsurgery for Early Rectal Cancer: A Single-Center Experience.

BACKGROUND: There is debate regarding the appropriate use of transanal endoscopic microsurgery for rectal cancer. OBJECTIVE: This study analyzed our single-center experience with transanal endoscopic microsurgery for early rectal cancer. DESIGN: Medical charts of patients who underwent transanal endoscopic microsurgery were reviewed to determine lesion characteristics, as well as operative and treatment characteristics. Complications and recurrences were recorded. SETTINGS: The study was conducted at a single academic medical center. PATIENTS: Patients with early stage cancer (T1 or T2, N0, and M0) of the rectum were included. MAIN OUTCOME MEASURES: Local and overall recurrence and disease-specific survival were measured. RESULTS: A total of 92 patients were analyzed. Median follow-up was 4.6 years. Negative margins were obtained in 98.9%. Length of stay was 1 day for 95.4% of patients. The complication rate was 10.9% (n = 10), including urinary retention at 4.3% (n = 4) and postoperative bleeding at 4.3% (n = 4). Preoperative staging included 54 at T1 (58.7%) and 38 at T2 (41.3%). Adjuvant therapy was recommended for all of the T2 and select T1 lesions with adverse features on histology. The final pathologic stages of tumors were ypT0 at 8.7% (n = 8), pT1 at 58.7% (n = 54), pT2 at 23.9% (n = 22), and ypT2 at 8.7% (n = 8). The 3-year local recurrence risk was 2.4% (SE = 1.7), and overall recurrence was 6.7% (SE = 2.9). There were no recurrences among patients with complete pathologic response to neoadjuvant therapy. Mean time to recurrence was 2.5 years (SD = 1.43). A total of 89.2% of patients with very low tumors underwent curative resection without a permanent stoma (33/37). The 3-year disease-specific survival rate was 98.6% (95% CI, 90.4%-99.8%), and overall survival rate was 89.4% (95% CI, 79.9%-94.6%). LIMITATIONS: The study was limited by its single-center retrospective experience. CONCLUSIONS: Transanal endoscopic microsurgery provides comparable oncologic outcomes to radical resection in properly selected patients with early rectal cancer. Sphincter preservation rates approach 90% even in patients with very distal rectal cancer.

Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial.

BACKGROUND: Local excision is an organ-preserving treatment alternative to transabdominal resection for patients with stage I rectal cancer. However, local excision alone is associated with a high risk of local recurrence and inferior survival compared with transabdominal rectal resection. We investigated the oncological and functional outcomes of neoadjuvant chemoradiotherapy and local excision for patients with stage T2N0 rectal cancer. METHODS: We did a multi-institutional, single-arm, open-label, non-randomised, phase 2 trial of patients with clinically staged T2N0 distal rectal cancer treated with neoadjuvant chemoradiotherapy at 26 American College of Surgeons Oncology Group institutions. Patients with clinical T2N0 rectal adenocarcinoma staged by endorectal ultrasound or endorectal coil MRI, measuring less than 4 cm in greatest diameter, involving less than 40% of the circumference of the rectum, located within 8 cm of the anal verge, and with an Eastern Cooperative Oncology Group performance status of at least 2 were included in the study. Neoadjuvant chemoradiotherapy consisted of capecitabine (original dose 825 mg/m(2) twice daily on days 1-14 and 22-35), oxaliplatin (50 mg/m(2) on weeks 1, 2, 4, and 5), and radiation (5 days a week at 1·8 Gy per day for 5 weeks to a dose of 45 Gy, followed by a boost of 9 Gy, for a total dose of 54 Gy) followed by local excision. Because of adverse events during chemoradiotherapy, the dose of capecitabine was reduced to 725 mg/m(2) twice-daily, 5 days per week, for 5 weeks, and the boost of radiation was reduced to 5·4 Gy, for a total dose of 50·4 Gy. The primary endpoint was 3-year disease-free survival for all eligible patients (intention-to-treat population) and for patients who completed chemotherapy and radiation, and had ypT0, ypT1, or ypT2 tumours, and negative resection margins (per-protocol group). This study is registered with ClinicalTrials.gov, number NCT00114231. FINDINGS: Between May 25, 2006, and Oct 22, 2009, 79 eligible patients were recruited to the trial and started neoadjuvant chemoradiotherapy. Two patients had no surgery and one had a total mesorectal excision. Four additional patients completed protocol treatment, but one had a positive margin and three had ypT3 tumours. Thus, the per-protocol population consisted of 72 patients. Median follow-up was 56 months (IQR 46-63) for all patients. The estimated 3-year disease-free survival for the intention-to-treat group was 88·2% (95% CI 81·3-95·8), and for the per-protocol group was 86·9% (79·3-95·3). Of 79 eligible patients, 23 (29%) had grade 3 gastrointestinal adverse events, 12 (15%) had grade 3-4 pain, and 12 (15%) had grade 3-4 haematological adverse events during chemoradiation. Of the 77 patients who had surgery, six (8%) had grade 3 pain, three (4%) had grade 3-4 haemorrhage, and three (4%) had gastrointestinal adverse events. INTERPRETATION: Although the observed 3-year disease free survival was not as high as anticipated, our data suggest that neoadjuvant chemoradiotherapy followed by local excision might be considered as an organ-preserving alternative in carefully selected patients with clinically staged T2N0 tumours who refuse, or are not candidates for, transabdominal resection. FUNDING: National Cancer Institute and Sanofi-Aventis.

Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial.

BACKGROUND: Patients with locally advanced rectal cancer who achieve a pathological complete response to neoadjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological complete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathological complete response. METHODS: We did a phase 2, non-randomised trial consisting of four sequential study groups of patients with stage II-III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradiation (fluorouracil 225 mg/m(2) per day by continuous infusion throughout radiotherapy, and 45·0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5·4 Gy). Patients in group 1 had total mesorectal excision 6-8 weeks after chemoradiation. Patients in groups 2-4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m(2) or 400 mg/m(2), according to the discretion of the treating investigator, oxaliplatin 85 mg/m(2) in a 2-h infusion, bolus fluorouracil 400 mg/m(2) on day 1, and a 46-h infusion of fluorouracil 2400 mg/m(2). The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00335816. FINDINGS: Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met criteria for analysis. 11 (18%, 95% CI 10-30) of 60 patients in group 1, 17 (25%, 16-37) of 67 in group 2, 20 (30%, 19-42) of 67 in group 3, and 25 (38%, 27-51) of 65 in group 4 achieved a pathological complete response (p=0·0036). Study group was independently associated with pathological complete response (group 4 compared with group 1 odds ratio 3·49, 95% CI 1·39-8·75; p=0·011). In group 2, two (3%) of 67 patients had grade 3 adverse events associated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neoadjuvant administration of mFOLFOX6 across groups 2-4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery-related complications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients). INTERPRETATION: Delivery of mFOLFOX6 after chemoradiation and before total mesorectal excision has the potential to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials. FUNDING: National Institutes of Health National Cancer Institute.

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.

Death after bowel resection: patient disease, not surgeon error.

INTRODUCTION: Although bowel resection is associated with a significant mortality rate, little is known about the demographics of the patients and how often surgical error is the primary cause of death. We sought to use a rigorous prospective quality database incorporating standardized peer review, to define how often patients die from provider-related causes. MATERIALS AND METHODS: All patients undergoing bowel resection with anastomosis at a university hospital from July 2003 to June 2006 were entered into a prospectively maintained quality database. Patients were seen daily with house staff by a specially trained nurse practitioner who recorded demographics and complications. Clinical case reviews were conducted monthly. Five hundred sixty-six patients underwent bowel resection with anastomosis during the study period. DISCUSSION: One hundred ninety-three patients suffered at least one complication (34.1%) and there were 20 deaths (3.5%). In 17 cases, death was deemed unavoidable due to patient disease; most occurred in patients who developed ischemic bowel while hospitalized for a serious concomitant illness. In only one case did death appear clearly related to a surgical complication (0.17%). Death after bowel resection typically reflects the need for urgent surgery in extreme circumstances and not surgeon error. Postoperative mortality rate in this population appears to be poor indicator of surgical quality.

Tracking outcomes of anorectal surgery: the need for a disease-specific quality assessment tool.

PURPOSE: We sought to determine the nature and timing of complications after common anorectal operations by using a prospective quality tracking tool. METHODS: A prospectively maintained quality database was queried to identify patients who underwent pilonidal sinus excision, hemorrhoidectomy, sphincterotomy, abscess drainage, or fistulotomy during an 11-year interval. All hospital complications were recorded by a single nurse practitioner and verified jointly by the surgical team. Any posthospital complications were registered at the first postoperative visit. RESULTS: A total of 969 patients underwent one of the five index anorectal procedures during the study period. Forty-nine complications occurred in 38 patients (3.9 percent). The majority of complications were minor (40/49; 82 percent) and were primarily urinary retention, minor bleeding, and wound infection. Twenty-five of the 40 minor complications (62 percent) were identified only after hospital discharge in the outpatient setting. Eight of the nine major complications occurred in patients already hospitalized for major concomitant illnesses and were unrelated to the anorectal surgery. The remaining patient had a postoperative deep vein thrombosis. CONCLUSIONS: Complications after anorectal procedures are infrequent, typically minor, and occur after hospital discharge. Major complications reflect concomitant illness, not surgical quality. Meaningful outcome measures are needed to assess the quality of anorectal surgery.

Transanal endoscopic microsurgery is more effective than traditional transanal excision for resection of rectal masses.

PURPOSE: Transanal endoscopic microsurgery, developed by Buess in the 1980s, has become increasingly popular in recent years. No large studies have compared the effectiveness of transanal endoscopic microsurgery with traditional transanal excision. METHODS: Between 1990 and 2005, 171 patients underwent traditional transanal excision (n = 89) or transanal endoscopic microsurgery (n = 82) for rectal neoplasms. Medical records were reviewed to determine type of surgery, resection margins, specimen fragmentation, complications, recurrence, lesion type, stage, and size. RESULTS: The groups were similar with respect to age, sex, lesion type, stage, and size. Mean follow-up was 37 months. There was no difference in the complication rate between the groups (transanal endoscopic microsurgery 15 percent vs. traditional transanal excision 17 percent, P = 0.69). Transanal endoscopic microsurgery was more likely to yield clear margins (90 vs. 71 percent, P = 0.001) and a nonfragmented specimen (94 vs. 65 percent, P < 0.001) compared with transanal excision. Recurrence was less frequent after transanal endoscopic microsurgery than after traditional transanal excision (5 vs. 27 percent, P = 0.004). CONCLUSIONS: Transanal endoscopic microsurgery is the technique of choice for local excision of rectal neoplasms.

Technical tips for stoma creation in the challenging patient.

Stoma creation is a mental and technical exercise, often straightforward without any difficulty. However, creation of a protruding, tension free, well-vascularized stoma in an obese individual with a thick abdominal wall and short, thickened mesentery can be a substantial challenge. Preoperative planning including stoma site marking, thoughtful consideration of all alternatives, and attention to technical detail will help create a stoma that will serve the ostomate well. The technical tips provided in this article should facilitate the process of selecting the appropriate intestinal segment, identifying the correct stoma site, and creating a functional stoma even in the most challenging situations.

Anastomotic leaks after intestinal anastomosis: it's later than you think.

PURPOSE: Anastomotic leaks are among the most dreaded complications after colorectal surgery. However, problems with definitions and the retrospective nature of previous analyses have been major limitations. We sought to use a prospective database to define the true incidence and presentation of anastomotic leakage after intestinal anastomosis. METHODS: A prospective database of two colorectal surgeons was reviewed over a 10-year period (1995-2004). The incidence of leak by surgical site, timing of diagnosis, method of detection, and treatment was noted. Complications were entered prospectively by a nurse practitioner directly involved in patient care. Standardized criteria for diagnosis were used. A logistic regression model was used to discriminate statistical variation. RESULTS: A total of 1223 patients underwent resection and anastomosis during the study period. Mean age was 59.1 years. Leaks occurred in 33 patients (2.7%). Diagnosis was made a mean of 12.7 days postoperatively, including four beyond 30 days (12.1%). There was no difference in leak rate by surgeon (3.6% vs. 2.2%; P = 0.08). The leak rate was similar by surgical site except for a markedly increased leak rate with ileorectal anastomosis (P = 0.001). Twelve leaks were diagnosed clinically versus 21 radiographically. Contrast enema correctly identified only 4 of 10 leaks, whereas CT correctly identified 17 of 19. A total of 14 of 33 (42%) patients had their leak diagnosed only after readmission. Fifteen patients required fecal diversion, whereas 18 could be managed nonoperatively. CONCLUSIONS: Anastomotic leaks are frequently diagnosed late in the postoperative period and often after initial hospital discharge, highlighting the importance of prospective data entry and adequate follow-up. CT scan is the preferred diagnostic modality when imaging is required. More than half of leaks can be managed without fecal diversion.

Transanal endoscopic microsurgery.

TEM has been used effectively to treat large rectal polyps and early rectal malignancy for more than 20 years in Europe. Until recently, only a few specialized centers offered TEM in the United States, where it is now gaining popularity. Many hospitals have purchased equipment and are offering TEM; however, the equipment is expensive and the learning curve is steep. Therefore, it is essential that anyone performing TEM have an adequate number of cases to develop and maintain expertise in this technique. That being said, TEM remains unique when compared with laparoscopy and other minimally invasive techniques that incorporate less invasive methods of performing old operations. TEM allows surgeons to perform operations that were impossible before the development and acceptance of this technique.

The New England colorectal cancer quality project: a prospective multi-institutional feasibility study.

BACKGROUND: The need for risk-adjusted databases to benchmark quality is well recognized. Data entry is typically performed by physician surrogates who are variably involved in patient care and might be unable to capture key elements of patient care known only to the operating surgeon. The primary purpose of this study was to assess the feasibility of developing a multi-institutional, prospective, surgeon-initiated database and, secondarily, to compare the data collected with chart review. STUDY DESIGN: The New England Colorectal Society project registry was a prospective, multi-institutional regional database of consecutive patients undergoing operation for colorectal cancer at 13 participating institutions from July 2003 to June 2004. Three sites were chosen for case entry compliance and a random 10% sampling of cases was selected for chart review. RESULTS: Five hundred sixty-nine patients were entered by 26 surgeons at 13 study sites. Two hundred nineteen complications were reported in 168 patients including 6 deaths (1.1%). Case entry compliance ranged from 45% to 100% by site and 25.5% to 100% by surgeon. There was at least one discrepancy between surgeon entry and chart review in 96% of cases; intraoperative complications and key surgical details reported by the surgeon were frequently absent from the chart. CONCLUSIONS: Surgeons will participate in a collaborative, multi-institutional quality database. Compliance was variable, indicating that surgeon data entry cannot reliably replace other means of data collection. The surgeon might be able to provide key pieces of data, not otherwise available, that can be critical to understanding and improving outcomes.

Practice parameters for the surgical treatment of ulcerative colitis.

The American Society of Colon and Rectal Surgeons is dedicated to assuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Standards Committee is composed of Society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus. This is accompanied by developing Clinical Practice Guidelines based on the best available evidence. These guidelines are inclusive, and not prescriptive. Their purpose is to provide information on which decisions can be made, rather than dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient.

Transanal endoscopic microsurgery: a prospective evaluation of functional results.

PURPOSE: Local excision is a commonly used technique for many benign and selected malignant rectal lesions. Compared with radical resection, it is associated with decreased morbidity and mortality and improved functional results. Transanal endoscopic microsurgery is gaining popularity because of its ability to access the upper rectum and its precise excision techniques. However, the functional consequences have not been extensively studied. METHODS: All patients subject to transanal endoscopic microsurgery prospectively completed preoperative and postoperative (6 weeks) surveys including Fecal Incontinence Severity Index, Fecal Incontinence Quality of Life, number of bowel movements per 24 hours, and ability to defer defecation. All data were collected by an independent research coordinator. Demographics, operative details, and complications were also collected prospectively. RESULTS: Forty-one patients successfully underwent transanal endoscopic microsurgery. Fourteen patients had malignant lesions and 27 had benign lesions. Two patients required abdominoperineal resection based on postoperative diagnosis. Thirty-nine patients have completed follow-up and were available for review. Mean length of surgery was 64 minutes and length of stay was 0.9 day. Average distance from the anal verge to the proximal tumor margin was 11.4 cm and mean tumor size was 8.75 cm. Twenty-three patients had full-thickness excision with primary closure, ten had full-thickness excision without closure, five had partial-thickness excision, one had an excision of a mass in the anovaginal septum, and one had resection of an anastomotic stricture. Each patient served as his own control. Preoperative and postoperative number of bowel movements per 24 hours were 2.0 and 2.0, respectively. Preoperative vs. postoperative urgency (ability to defer defecation less than ten minutes) was unchanged. Mean preoperative and postoperative Fecal Incontinence Severity Index scores were 2.4 (range, 0-43) and 2.4 (range, 0-17), respectively (higher scores indicate worse function). In addition, the four parameters measured by the Fecal Incontinence Quality of Life survey were unchanged when preoperative and postoperative data were compared. CONCLUSIONS: Transanal endoscopic microsurgery allows precise excision of tumors throughout the rectum. However, it involves inserting a 40-mm-diameter operating proctoscope and significant operating times. Despite this, as measured by ability to defer defecation, number of bowel movements per 24 hours, Fecal Incontinence Severity Index, and Fecal Incontinence Quality of Life survey, transanal endoscopic microsurgery has no detrimental affect on fecal continence.