Improved Survival After Adjuvant Therapy in Locally Advanced Rectal Cancer Patients With Pathologic Complete Response.

BACKGROUND: The benefit of adjuvant therapy is unclear in patients with rectal cancer achieving a pathologic complete response after neoadjuvant chemoradiotherapy and total mesorectal excision. OBJECTIVE: This study aimed to assess the benefit of adjuvant chemotherapy on survival among rectal cancer patients with a pathologic complete response after neoadjuvant chemoradiation. DESIGN: Retrospective cohort study. SETTING: National Cancer Database (2004-2017). PATIENTS: Patients with clinical stage 2 or 3 rectal adenocarcinoma who underwent neoadjuvant chemoradiation (50-50.4 Gy in 25-28 fractions) followed by total mesorectal excision with a pathologic complete response were included. INTERVENTION: Adjuvant chemotherapy. MAIN OUTCOME MEASURES: Overall survival. RESULTS: There were 20,518 patients and 2221 (11%) had a pathologic complete response after neoadjuvant chemoradiation. Of 2221 patients, 1441 (65%) did not receive adjuvant therapy and 780 (35%) did. Patients who received adjuvant therapy were more likely to be younger (median 58 vs 62 y), have private insurance (61% vs 49%), and have node-positive disease (57% vs 48%) (all p < 0.05). There were no differences in sex, race, Charlson-Deyo score, clinical T-stage, tumor size and differentiation, adequate lymphadenectomy (12 or more), or sphincter preservation between groups (all p > 0.05). Overall survival at 5, 10, and 14 years was significantly longer in the adjuvant group (93%, 85%, 83%, respectively) compared to patients who did not receive adjuvant therapy (87%, 67%, 51%, respectively) ( p < 0.001). In a subgroup analysis, adjuvant therapy was associated with improved survival in patients with clinical stage 2 and 3 rectal cancer ( p < 0.001). After adjusting for patient and tumor characteristics, omission of adjuvant chemotherapy was associated with significantly worse survival (HR 1.53, 95% 1.08-2.16). LIMITATIONS: Selection bias, unknown perioperative morbidity, chemotherapy regimen, recurrence status, and other unidentified factors limiting survival analysis. CONCLUSIONS: In patients with clinical stage 2 or 3 rectal cancer, adjuvant chemotherapy was associated with improved overall survival in patients achieving a pathological complete response after neoadjuvant chemoradiotherapy. See Video Abstract at http://links.lww.com/DCR/C139 . SOBREVIDA MEJORADA DESPUS DE LA TERAPIA ADYUVANTE EN PACIENTES CON CNCER DE RECTO LOCALMENTE AVANZADO CON RESPUESTA PATOLGICA COMPLETA: ANTECEDENTES:En los pacientes con cáncer de recto que logran una respuesta patológica completa después de la quimiorradioterapia neoadyuvante y la escisión total del mesorrecto, el beneficio de la terapia adyuvante no está claro.OBJETIVO:Evaluar el beneficio de la quimioterapia adyuvante en la sobrevida de los pacientes con cáncer de recto con una respuesta patológica completa después de la quimiorradioterapia neoadyuvante.DISEÑO:Estudio de cohorte retrospectivo.ESCENARIO:Base de Datos Nacional de Cáncer (2004-2017).PACIENTES:Pacientes con adenocarcinoma rectal en estadio clínico 2 ó 3 que se sometieron a quimiorradiación neoadyuvante (50-50,4 Gy en 25-28 fracciones) seguida de escisión mesorrectal total con una respuesta patológica completa.INTERVENCIÓN:Quimioterapia adyuvante.PRINCIPALES MEDIDAS DE RESULTADO:Sobrevida global.RESULTADOS:Hubo 20.518 pacientes y 2.221 (11%) tuvieron una respuesta patológica completa después de la quimiorradiación neoadyuvante. Entre estos 2221 pacientes, 1441 (65%) no recibieron terapia adyuvante y 780 (35%) sí. Los pacientes que recibieron terapia adyuvante tenían más probabilidades de ser más jóvenes (mediana de 58 frente a 62 años), tener un seguro privado (61% frente a 49%) y tener enfermedad con linfonodos positivos (57% frente a 48 %) (todos p < 0,05). No hubo diferencias en género, raza, puntuación de Charlson-Deyo, estadio T clínico, tamaño y diferenciación del tumor, linfadenectomía adecuada (≥12) o preservación del esfínter entre los grupos (todos p > 0,05). La sobrevida general a los 5, 10 y 14 años fue significativamente mayor en el grupo adyuvante (93%, 85%, 83%, respectivamente) en comparación con los pacientes que no recibieron terapia adyuvante (87%, 67%, 51% respectivamente) ( p < 0,001). En un análisis de subgrupos, la terapia adyuvante se asoció con una mejor sobrevida general en pacientes con cáncer de recto en estadio clínico 2 y 3 ( p < 0,001). Después de ajustar por las características del paciente y del tumor, la omisión de la quimioterapia adyuvante se asoció con una sobrevida global significativamente peor (HR 1,53, IC del 95%, 1,08-2,16).LIMITACIONES:Sesgo de selección; morbilidad perioperatoria desconocida, régimen de quimioterapia, estado de recurrencia y otros factores no identificados que limitan el análisis de sobrevida.CONCLUSIONES:En pacientes con cáncer de recto en estadio clínico 2 ó 3, la quimioterapia adyuvante se asoció con una mejor sobrevida general en pacientes que lograron una respuesta patológica completa después de la quimiorradioterapia neoadyuvante. Consulte Video Resumen en http://links.lww.com/DCR/C139 . (Traducción-Dr. Felipe Bellolio ).

Rectal Cancer: Clinical and Molecular Predictors of a Complete Response to Total Neoadjuvant Therapy.

BACKGROUND: Total neoadjuvant therapy in rectal cancer may increase pathological complete response rates, potentially allowing for a nonoperative approach. OBJECTIVE: The objective of this study was to identify patient and tumor characteristics that predict a complete response following total neoadjuvant therapy. DESIGN: This was a retrospective cohort study. SETTINGS: This study was conducted at a university-based National Cancer Institute-designated Comprehensive Cancer Center. PATIENTS: The patients include those with stage 2 or 3 rectal adenocarcinoma. INTERVENTIONS: Interventions included total neoadjuvant therapy, total mesorectal excision, and nonoperative management. MAIN OUTCOME MEASURES: Complete response was defined as either patients with a clinical complete response undergoing nonoperative management who remained cancer-free or patients undergoing surgery with a pathological complete response. RESULTS: Among 102 patients, median age was 54 years, 69% were male, median carcinoembryonic antigen level was 3.0 ng/mL, and the median distance of the tumor above the anorectal ring was 3 cm. Thirty-eight (37%) patients had a complete response, including 15 of 18 (83%) nonoperative patients who remained cancer free at a median of 22 months (range, 7-48 months) and 23 of 84 (27%) patients who underwent surgery and had a pathological complete response. The incomplete response group consisted of 61 patients who underwent initial surgery and 3 nonoperative patients with regrowth. There were no differences in gender, T-stage, or tumor location between groups. Younger age (median, 49 vs 55 years), normal carcinoembryonic antigen (71% vs 41%), clinical node-negative (24% vs 9%), smaller tumors (median 3.9 vs 5.4 cm), and wild-type p53 (79% vs 47%) and SMAD4 (100% vs 81%) were more likely to have a complete response (all p < 0.05). LIMITATIONS: This was a retrospective study with a small sample size. CONCLUSIONS: In patients with rectal cancer treated with total neoadjuvant therapy, more than one-third will achieve a pathological complete response or sustained clinical complete response with nonoperative management, making oncological resection superfluous in these patients. Smaller, wild-type p53 and SMAD4, and clinically node-negative cancers are predictive features of a complete response. See Video Abstract at http://links.lww.com/DCR/B889 . CNCER DE RECTO PREDICTORES CLNICOS Y MOLECULARES DE UNA RESPUESTA COMPLETA A LA TERAPIA NEOADYUVANTE TOTAL: ANTECEDENTES:La terapia neoadyuvante total en el cáncer de recto puede aumentar las tasas de respuesta patológica completa y permitir potencialmente un enfoque no quirúrgico.OBJETIVO:El objetivo fue identificar las características tanto del paciente y del tumor que logren predecir una respuesta completa después de la terapia neoadyuvante total.DISEÑO:Este fue un estudio de cohorte retrospectivo.AJUSTES:Este estudio se realizó en un Centro Integral de Cáncer designado por el Instituto Nacional del Cáncer con sede universitaria.PACIENTES:Los pacientes incluyen aquellos con adenocarcinoma de recto en estadio 2 o 3.INTERVENCIONES:Terapia neoadyuvante total, escisión total del mesorrecto, manejo conservador no quirúrgico.PRINCIPALES MEDIDAS DE RESULTADO:La respuesta completa se definió como pacientes con una respuesta clínica completa sometidos a tratamiento no quirúrgico que permanecieron libres de cáncer o pacientes sometidos a cirugía con una respuesta patológica completa.RESULTADOS:Entre 102 pacientes, la mediana de edad fue de 54 años, el 69% fueron hombres, la mediana del nivel de antígeno carcinoembrionario fue de 3.0 ng/ml y la mediana de la distancia del tumor por encima del anillo anorrectal fue de 3 cm. Thirty-eight (37%) pacientes tuvieron una respuesta completa que incluyó a 15 de 18 (83%) pacientes con manejo no operatorio y que permanecieron libres de cáncer en una mediana de 22 meses (rango 7- 48 meses) y 23 de 84 (27%) pacientes que fueron sometidos a cirugía y tuvieron una respuesta patológica completa. El grupo de respuesta incompleta consistió en 61 pacientes que fueron sometidos inicialmente a cirugía y 3 pacientes no quirúrgicos con recrecimiento. No se encontró diferencias de género, estadio T o ubicación del tumor entre los grupos. Edad más joven (mediana 49 frente a 55), antígeno carcinoembrionario normal (71% frente a 41%), ganglios clínicos negativos (24% frente a 9%), tumores más pequeños (mediana de 3,9 frente a 5,4 cm) y p53 de tipo salvaje (79 % vs 47%) y SMAD4 (100% vs 81%) tenían más probabilidades de tener una respuesta completa (todos p < 0,05).LIMITACIONES:Este fue un estudio retrospectivo y con un tamaño de muestra pequeño.CONCLUSIONES:En pacientes con cáncer de recto tratados con terapia neoadyuvante total, más de un tercio logrará una respuesta patológica completa o una respuesta clínica completa sostenida con manejo no operatorio, logrando que la resección oncológica sea superflua en estos pacientes. Los cánceres más pequeños, clínicamente con ganglios negativos, con p53 de tipo salvaje y SMAD4, son características predictoras de una respuesta completa. Consulte Video Resumen en http://links.lww.com/DCR/B889 . (Traducción-Dr. Osvaldo Gauto ).

Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

Improved survival in rectal cancer patients who are treated with long-course versus short-course neoadjuvant radiotherapy: A propensity-matched analysis of the NCDB.

BACKGROUND: Randomized controlled trials have demonstrated comparable survival outcomes for short-course (SCRT) and long-course neoadjuvant radiotherapy (LCRT) in patients with rectal cancer. METHODS: Using the National Cancer Data Base (2004-2015), a propensity score was used to match 188 patients with rectal cancer receiving SCRT to 376 patients receiving LCRT. Perioperative, oncologic, and survival outcomes were compared. RESULTS: Patient and clinical tumor characteristics were similar between groups. Patients in the LCRT were more likely to undergo surgery (91% vs 85%; P = 0.03). The LCRT group were more likely to have tumor (T) (56% vs 43%) and nodal (N) (25% vs 19%) downstaging, and a complete pathological response (15% vs 6%) compared with the SCRT group (all P < 0.05). Length of stay (6 vs 8 days), 30-day (1% vs 5%) mortality, and 90-day mortality (1% vs 10%) were significantly lower in the LCRT group (all P < 0.05). After adjusting for patient and tumor-related characteristics, LCRT was associated with a 50% reduction in the risk of mortality compared with SCRT (hazard ratios, 0.50; 95% confidence interval, 0.35-0.70). CONCLUSIONS: In this analysis, LCRT was superior to SCRT in terms of tumor response to neoadjuvant therapy, perioperative mortality, and overall survival. These findings provide evidence for the use of LCRT when neoadjuvant therapy is indicated.

Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse.

PURPOSE: Pelvic floor abnormalities often affect multiple organs. The incidence of concomitant uterine/vaginal prolapse with rectal prolapse is at least 38%. For these patients, addition of sacrocolpopexy to rectopexy may be appropriate. Our aim was to determine if addition of sacrocolpopexy to rectopexy increases the procedural morbidity over rectopexy alone. METHODS: We utilized the ACS-NSQIP database to examine female patients who underwent rectopexy from 2005 to 2014. We compared patients who had a combined procedure (sacrocolpopexy and rectopexy) to those who had rectopexy alone. Thirty-day morbidity was compared and a multivariable model constructed to determine predictors of complications. RESULTS: Three thousand six hundred patients underwent rectopexy; 3394 had rectopexy alone while 206 underwent a combined procedure with the addition of sacrocolpopexy. Use of the combined procedure increased significantly from 2.6 to 7.7%. Overall morbidity did not differ between groups (14.8% rectopexy alone vs. 13.6% combined procedure, p = 0.65). Significant predictors of morbidity included addition of resection to a rectopexy procedure, elevated BMI, smoking, wound class, and ASA class. After controlling for these and other patient factors, the addition of sacrocolpopexy to rectopexy did not increase overall morbidity (OR 1.00, p = 0.98). CONCLUSIONS: There is no difference in operative morbidity when adding sacrocolpopexy to a rectopexy procedure. Despite a modest increase in utilization of combined procedures over time, the overall rate remains low. These findings support the practice of multidisciplinary evaluation of patients presenting with rectal prolapse, with the goal of offering concurrent surgical correction for all compartments affected by pelvic organ prolapse disorders.

A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery.

BACKGROUND: Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery. Key to its pathogenesis is the degree of intraoperative bacterial contamination at the surgical site. The purpose of this study was to evaluate a novel wound retractor at reducing bacterial contamination. METHODS: A prospective multicenter pilot study utilizing a novel wound retractor combining continuous irrigation and barrier protection was conducted in patients undergoing elective colorectal resections. Culture swabs were collected from the incision edge prior to device placement and from the exposed and protected incision edge prior to device removal. The primary and secondary endpoints were the rate of enteric and overall bacterial contamination on the exposed incision edge as compared to the protected incision edge, respectively. The safety endpoint was the absence of serious device-related adverse events. RESULTS: A total of 86 patients were eligible for analysis. The novel wound retractor was associated with a 66% reduction in overall bacterial contamination at the protected incision edge compared to the exposed incision edge (11.9 vs. 34.5%, P < 0.001), and 71% reduction in enteric bacterial contamination (9.5% vs. 33.3%, P < 0.001). The incisional SSI rate was 2.3% in the primary analysis and 1.2% in those that completed the protocol. There were no adverse events attributed to device use. CONCLUSIONS: A novel wound retractor combining continuous irrigation and barrier protection was associated with a significant reduction in bacterial contamination. Improved methods to counteract wound contamination represent a promising strategy for SSI prevention (NCT 02413879).

Impaired outcome colitis-associated rectal cancer versus sporadic cancer.

BACKGROUND: The surgical management of colitis-associated rectal cancer (CARC) is not well defined. This study determines outcomes after surgery for CARC compared with sporadic rectal cancer. MATERIALS AND METHODS: This is a retrospective cohort study comparing 27 patients with CARC with 54 matched patients with sporadic cancer. Matching criteria included age, gender, neoadjuvant chemoradiation, and American Joint Committee on Cancer stage. Outcome measures were disease-free and overall survival, tumor characteristics, and postoperative morbidity. RESULTS: Compared to those with sporadic rectal cancer, patients with CARC underwent proctocolectomy more frequently (21 [78%] versus 6 [22%] P < 0.001) and were more likely to have mucinous tumors (11 [40.7%] versus 12 [22.3%] P = 0.03). Overall 3-y survival was significantly reduced in CARC patients compared with patients with sporadic rectal cancer. Those with CARC undergoing segmental proctectomy only demonstrated reduced overall and disease-free survival compared to patients with sporadic rectal cancer and to colitis patients undergoing proctocolectomy (P = 0.002). CONCLUSIONS: Patients with CARC undergoing proctectomy demonstrate reduced disease-free survival versus those undergoing proctocolectomy, and versus patients with sporadic rectal cancer undergoing proctectomy. These findings warrant further study and suggest that proctocolectomy should be considered the preferred surgical approach for CARC.

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial.

IMPORTANCE: Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE: To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS: Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES: The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation. RESULTS: Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE: Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00726622.

Accordion complication grading predicts short-term outcome after right colectomy.

BACKGROUND: The Accordion severity grading system is a novel system to score the severity of postoperative complications in a standardized fashion. This study aims to demonstrate the validity of the Accordion system in colorectal surgery by correlating severity grades with short-term outcomes after right colectomy for colon cancer. METHODS: This is a retrospective cohort review of patients who underwent right colectomy for cancer between January 1, 2002, and January 31, 2007, at a single tertiary care referral center. Complications were categorized according to the Accordion severity grading system: grades 1 (mild), 2 (moderate), 3-5 (severe), and 6 (death). Outcome measures were hospital stay, 30-d readmission rate and 1-y survival. Correlation between Accordion grades and outcome measures is reflected by Spearman rho (ρ). One-year survival was obtained per Kaplan-Meier method and compared by logrank test for trend. Significance was set at P ≤ 0.05. RESULTS: Overall, 235 patients underwent right colectomy for cancer of which 122 (51.9%) had complications. In total, 52 (43%) had an Accordion grade 1 complication; 44 (36%) grade 2; four (3%) grade 3; 11 (9%) grade 4; seven (6%) grade 5; and four (3%) grade 6. There was significant correlation between Accordion grades and hospital stay (ρ = 0.495, P < 0.001) and 30-d readmission rate (ρ = 0.335, P < 0.001). There was a significant downward trend in 1-y survival as complication severity by Accordion grade increased (P = 0.02). CONCLUSIONS: The Accordion grading system is a useful tool to estimate short-term outcomes after right colectomy for cancer. High-grade Accordion complications are associated with longer hospital stay and increased risk of readmission and mortality.

Time to initiation of postoperative chemotherapy: an outcome measure for patients undergoing laparoscopic resection for rectal cancer.

BACKGROUND: Laparoscopic rectal cancer surgery has limited short-term benefits in comparison with open surgery. Long-term measures of recovery are needed. OBJECTIVE: The aim of this study was to assess the impact of surgical approach (laparoscopic vs open) for the treatment of rectal cancer on the time to postoperative chemotherapy. DESIGN: This study is a retrospective review of 150 patients who underwent low anterior resection and received postoperative chemotherapy between 2005 and 2011. SETTINGS: This study was conducted at a tertiary care hospital. PATIENTS: One hundred fifty patients who had stage II or III rectal cancer who underwent low anterior resection were selected. All patients received postoperative chemotherapy, the timing of which was at the discretion of the oncologist. MAIN OUTCOME MEASURES: Patient demographics, clinicopathologic variables, and time to postoperative chemotherapy were compared. Multivariate analysis was performed to identify variables affecting the time to postoperative chemotherapy. RESULTS: There were no differences in clinicopathologic variables between cohorts including age, BMI, sex, ASA score, diverting ileostomy, preoperative radiotherapy, or pathologic stage. Univariate analysis demonstrated differences in intraoperative blood loss (300 vs 448 mL, p < 0.01), length of stay (7.6 vs 8.9 days, p < 0.05), wound infection (12.0 vs 24.0%, p < 0.05), and tumor location (8.0 vs 6.9 cm, p < 0.05) for laparoscopic vs open patients. There were more complications in the open vs laparoscopic group (47 vs 24, p < 0.001); however, the percentage of patients experiencing complications in the open vs laparoscopic cohorts did not reach statistical significance (32.0 vs 18.7%, p = 0.09). A decrease in mean time to postoperative chemotherapy was found for patients undergoing laparoscopic vs open surgery (50.1 vs 75.2 days, p < 0.0001). Multivariate analysis demonstrated that the approach of surgery was an independent predictor of time to postoperative chemotherapy (p < 0.01). LIMITATIONS: This study was limited by its retrospective design and selection bias. CONCLUSIONS: In selected patients, patients undergoing laparoscopic rectal cancer surgery receive postoperative chemotherapy 25 days earlier than patients undergoing open surgery. Time to postoperative chemotherapy serves as an outcome measure for improved recovery in laparoscopic rectal cancer surgery.

Total Neoadjuvant Therapy in Rectal Cancer: Multi-center Comparison of Induction Chemotherapy and Long-Course Chemoradiation Versus Short-Course Radiation and Consolidative Chemotherapy.

BACKGROUND: Total neoadjuvant therapy for locally advanced rectal cancer may include induction chemotherapy and chemoradiation or short-course radiotherapy and consolidative chemotherapy. METHODS: Patients with clinical stage 2 or 3 rectal cancer who received induction chemotherapy followed by long-course chemoradiation at the University of Colorado (2016-2020) or short-course radiotherapy followed by consolidative chemotherapy at Washington University (2017-2020) were assessed. RESULTS: Eighty-four patients received induction chemotherapy and chemoradiation and 83 received short-course radiotherapy and consolidative chemotherapy. Among patients with complete re-staging evaluation, clinical complete response rates were similar, 49% (18/37) and 53% (44/83), respectively (p = 0.659). In the induction chemotherapy and chemoradiation group, 80% (n = 67) underwent surgery and 28% (n = 19) achieved a pathologic complete response. In the short-course radiotherapy and consolidative chemotherapy group, 44 (53%) patients underwent surgery and 11% (n = 5) had a pathologic complete response. Overall, a complete response was observed in 43% (n = 36) of patients who received induction chemotherapy and chemoradiation compared to 53% (n = 44) who received short-course radiotherapy and consolidative chemotherapy (p = 0.189). Perioperative outcomes were similar in patients who received induction chemotherapy and chemoradiation compared to short-course radiotherapy and consolidative chemotherapy: intraoperative complications (2% vs 7%), complete mesorectal specimen (85% vs 84%), anastomotic leak (9% vs 7%), organ/space infection (9% vs 5%), readmission (19% vs 21%), and reoperation (8% vs 9%), respectively (all p > 0.05). CONCLUSIONS: In patients with clinical stage 2 or 3 rectal cancer, total neoadjuvant therapy with either induction chemotherapy and chemoradiation or short-course radiotherapy followed by consolidative chemotherapy were associated with similar perioperative morbidity and complete response rates.

Is an elective diverting colostomy warranted in patients with an endoscopically obstructing rectal cancer before neoadjuvant chemotherapy?

BACKGROUND: Many surgeons prefer immediate diversion in patients with endoscopically obstructed rectal cancer before starting neoadjuvant chemotherapy. OBJECTIVE: The aim of this study was to compare immediate neoadjuvant chemoradiotherapy with diversion for endoscopically obstructed rectal cancer. DESIGN: This study is a retrospective review of patients with rectal adenocarcinoma treated from January 2000 to December 2009. Demographic, tumor, treatment, and outcome data were obtained. Data were analyzed by the use of the Fisher exact probability test and the Student t test. SETTINGS: This study was conducted at a tertiary care hospital/referral center. PATIENTS: Included were patients with a rectal adenocarcinoma unable to be traversed endoscopically but without clinical evidence of obstruction before the initiation of neoadjuvant chemoradiotherapy. Patients with recurrent tumors or those who did not complete neoadjuvant chemoradiotherapy because of compliance were excluded. MAIN OUTCOME MEASURES: The primary outcomes measured were the interval from diagnosis to neoadjuvant chemoradiotherapy initiation and resection and the incidence of complete obstruction. RESULTS: Eighty-five patients with endoscopically obstructed rectal cancer were identified; 16 underwent immediate diversion before neoadjuvant chemoradiotherapy (diverted group) and 69 were treated with immediate neoadjuvant chemoradiotherapy. Five patients undergoing immediate neoadjuvant chemoradiotherapy presented with bloating and distension; 2 were treated with dietary modification, and 3 (4.3%) progressed to complete obstruction following completion of neoadjuvant chemoradiotherapy and required diversion. Both groups were similar in age, tumor height, and surgical margin status. Patients undergoing diversion required a significantly greater number of permanent stomas and were associated with a higher rate of radical pelvic surgery. There was a significant delay in the initiation of neoadjuvant chemoradiotherapy (p < 0.05) and proctectomy (p < 0.001) from the time of diagnosis in the diverted group compared with the immediate neoadjuvant chemoradiotherapy group. The tumors of patients undergoing diversions were more likely to be unresectable following neoadjuvant chemoradiotherapy. LIMITATIONS: This study was limited by its retrospective design and possible selection bias. CONCLUSIONS: Immediate diversion is unnecessary in endoscopically obstructed rectal cancer without clinical signs of obstruction. There appears to be a relationship between immediate diversion and delay in initiation of neoadjuvant chemoradiotherapy and proctectomy. We conclude that immediate neoadjuvant chemoradiotherapy in patients with endoscopically obstructed rectal cancer is safe and feasible.

Social vulnerability is associated with increased morbidity following colorectal surgery.

INTRODUCTION: Neighborhood measures of social vulnerability encompassing multiple sociodemographic factors can be used to quantify disparities in outcomes. We hypothesize patients with high Social Vulnerability Index (SVI) are at increased risk of morbidity following colectomy. METHODS: We used local 2012-2017 National Surgical Quality Improvement Program (NSQIP) data to study colectomy patients, examining associations between SVI and postoperative outcomes. RESULTS: We included 976 patients from five hospitals. High SVI (>75th percentile) was associated with increased postoperative morbidity on unadjusted analysis (OR 1.84, 95% CI 1.35-2.52, p < 0.001); this association persisted after adjusting for demographics and comorbidities (OR 1.63, 95% CI 1.15-2.31, p = 0.005). The association with SVI was not significant after adjusting for perioperative risk modifiers such as emergent presentation (OR 1.37, 95% CI 0.95-1.98, p = 0.10). CONCLUSIONS: High social vulnerability is associated with increased postoperative complications. This effect appears mediated by perioperative risk factors, suggesting potential to improve outcomes by facilitating timely surgical intervention.

Laparoscopic vs open resection for patients with rectal cancer: comparison of perioperative outcomes and long-term survival.

PURPOSE: The aim of the study is to assess the safety and oncologic feasibility of laparoscopic-assisted resection for rectal cancer vs open rectal resection as a phase II pilot study for a planned randomized control trial. METHODS: A case-matched controlled prospective analysis of 54 patients who underwent laparoscopic-assisted resection for stage I to III (no T4) rectal cancer within 12 cm of the anal verge from 2002 to 2005 was performed. Patients were matched with contemporary patients who underwent open rectal cancer surgery (n = 108) in a 1 to 2 fashion. The perioperative clinical outcomes, postoperative pathology, and oncologic outcomes were compared between the groups. RESULTS: The demographic data did not differ significantly between the groups. The laparoscopic group manifested early return of bowel function (P = .003). The complication rate was 22.2% in the laparoscopic group and 32.4% in the open group (P = .178). Local recurrence was similar (2.0% laparoscopic, 4.2% open, P = .417). The 5-year overall and disease-free survival rate also were similar (overall survival, 90.8% laparoscopic, 88.5% open, P = .261; disease-free survival, 80.8% laparoscopic, 75.8% open. P = .390). CONCLUSION: The laparoscopic-assisted resection for rectal cancer was acceptable in terms of oncologic outcomes and perioperative clinical outcomes. The present data are the basis for a large-scale randomized trial for comparison of laparoscopic and open rectal cancer surgeries (American College of Surgeons Oncology Group Z6051).

The efficacy of nonoperative management of acute complicated diverticulitis.

BACKGROUND: The surgical management of acute complicated diverticulitis has evolved to avoid emergency surgery in favor of elective resection. The optimal manner to accomplish this goal remains debatable. OBJECTIVE: The purpose of this study was to examine the efficacy of nonoperative management of acute diverticulitis with abscess or perforation. DESIGN: A retrospective review was performed of an institutional review board-approved database of patients admitted with a diagnosis of acute complicated diverticulitis from 1995 to 2008. Patient demographics, disease manifestation, management, and outcomes were collected. SETTINGS: This study was conducted at a tertiary care hospital/referral center. PATIENTS: Patients were included who presented with complicated diverticulitis defined as having an associated abscess or free air diagnosed by CT scan. MAIN OUTCOME MEASURES: Primary end points were the success of nonoperative management and need for surgery during the initial admission. RESULTS: One hundred thirty-six patients were identified with perforated diverticulitis: 19 had localized free air, 45 had abscess <4 cm or distant free air measuring <2 cm, 66 had abscess >4 cm or distant free air >2 cm, and 6 had distant free air with free fluid. Thirty-eight patients (28%) required percutaneous abscess drains and 37 (27%) required parenteral nutrition. Only 5 patients (3.7%) required urgent surgery at the time of admission, and 7 (5%) required urgent surgery for failed nonoperative management. Thus, the overall success rate of nonoperative management was 91%. One hundred twenty-four of 131 (95%) patients were treated with nonoperative management successfully. Twenty-five of 27 (92.5%) patients with free air remote from the perforation site were successfully treated nonoperatively. CONCLUSIONS: Nonoperative management of acute complicated diverticulitis is highly effective. For patients with free air remote from the site of perforation, nonoperative management is able to convert an emergent situation into an elective one in 93% of cases. The decision to attempt nonoperative therapy must be made based on the patient's physiologic state and associated comorbidities.

Laparoscopic colectomy using cancer principles is appropriate for colonoscopically unresectable adenomas of the colon.

PURPOSE: This study was undertaken to determine the risks of cancer in unresectable polyps and to compare the short-term outcome of laparoscopic colectomy with that of open colectomy for benign polyps. METHODS: A retrospective review of all patients (n = 165) undergoing colectomy for an adenoma unresectable at colonoscopy was performed on patients collected in a prospective database. One hundred four patients underwent laparoscopic colectomy and 61 underwent open colectomy between 1991 and 2003. Follow-up was 7 to 155 (median, 90) months. RESULTS: In the laparoscopic group, 85% of the patients underwent a right colectomy and 15% underwent a left colectomy or a sigmoidectomy. Conversion to open colectomy occurred in 4.8% of the cases. Complications occurred in 14% of the patients, including 1 death. The median length of stay was 4 days. At final pathology, cancer was diagnosed in 15 patients: stage I in 8 patients, stage II in 5, and stage III in 2. In the open colectomy group, 69% of the patients underwent right colectomy. The complication rate reached 23% (P = .13), including death in 2 patients. The median length of stay was 6 days (P < .01). Cancer was diagnosed in 6 patients: stage I in 5 patients, and stage II in 1. Proximal (10 cm) and distal (13 cm) margins, lymph nodes harvest (9), incidence of cancer (13%), and high-grade dysplasia (22%) were similar between groups. There were no local recurrences, trocar site implants, or deaths due to cancer. CONCLUSION: Laparoscopic colectomy for polyps unresectable at colonoscopy is safe. Oncologic resection of the colon should be performed for all colonoscopically unresectable polyps due to the risk of cancer.

Ex vivo sentinel lymph node mapping in patients undergoing proctectomy for rectal cancer.

PURPOSE: Controversy exists over the utility of sentinel lymph node mapping in the treatment of rectal cancer. The purpose of this study was to evaluate the use of ex vivo sentinel lymph node mapping in the setting of proctectomy for rectal cancer, with and without multilevel sectioning and immunohistochemistry. METHODS: A prospective phase 2 clinical study of subjects undergoing proctectomy for rectal cancer from 2003 to 2008 was conducted. Sentinel lymph node mapping was performed with ex vivo injection of isosulfan blue. Sentinel lymph nodes were examined by hematoxylin and eosin evaluation, and when the results were negative, they were examined by multilevel sectioning and immunohistochemistry. RESULTS: The study population consisted of 58 subjects; 88% received neoadjuvant therapy. Tumors were downstaged in 25 (49%) subjects receiving neoadjuvant therapy, 24% were clinical complete responders, and 20% were pathologic complete responders. The mean total lymph node harvest was 12.1 nodes per patient. Twenty-five subjects had positive nodal disease on final pathology. The sentinel lymph node detection rate was 85%, with a mean sentinel lymph node harvest of 2.2 nodes per subject. Fifteen (26%) subjects had sentinel lymph node nodal metastasis on routine hematoxylin and eosin examination. Neither multilevel sectioning nor immunohistochemistry evaluation improved detection of sentinel lymph node positivity. The accuracy of sentinel lymph node mapping was 71%, the sensitivity was 53%, the negative predictive value was 79%, and the false negative rate was 47%. Seven subjects were determined to have nodal disease only in the sentinel lymph node. CONCLUSION: Ex vivo sentinel lymph node mapping is feasible after proctectomy for rectal cancer but did not improve staging. Neither multilevel sectioning nor immunohistochemistry improved the sensitivity of sentinel lymph node mapping.

Stage IV rectal cancer with liver metastases: is there a benefit to resection of the primary tumor?

BACKGROUND: Resection of primary and liver lesions is the optimal management of Stage IV rectal cancer with liver metastases. For patients with extensive liver metastases, FOLFOX and FOLFIRI have improved resection rates and survival. We compared survival outcomes in patients with Stage IV rectal cancer with liver metastases undergoing staged or synchronous resection with those undergoing primary rectal resection only or no resection at all. METHODS: Patients with metastatic rectal cancer to liver were identified from a colorectal cancer database from 2002 to 2008. Patients received neoadjuvant chemoradiation and adjuvant FOLFOX or FOLFIRI therapy. The outcomes for patients who underwent synchronous resection, staged resection, resection of rectal tumor only, and no resection with chemotherapy only were compared. Statistical analysis was determined by ANOVA. Survival was determined using the Kaplan-Meier method. RESULTS: Seventy-four patients were identified: 30 synchronous resections, 13 staged resections, 22 primary resection only, and 9 no resection. Median follow-up was 23 months (range = 4-58 months). Sixty-five percent of patients underwent liver resection with 26% rendered eligible for resection after adjuvant therapy. Those who underwent primary resection only had shorter median survival than those who underwent either staged or synchronous liver resection (31 vs. 47 vs. 46 months, respectively; P = 0.17). Survival was no different for synchronous versus staged resection (P = 0.6). Volume of liver disease predicted resectability (P = 0.001). Without liver resection, 2-year survival was approximately 60%. Palliative surgery was required in six of nine patients who did not undergo resection of their primary tumor. CONCLUSIONS: Current chemotherapeutic regimens lead to improved survival in patients with unresectable liver metastases. Upfront chemotherapy in the asymptomatic patient compared with resection of the primary tumor does not appear to significantly affect survival. However, given that 60% of patients were alive after 2 years, resection of the primary lesion for palliative reasons and local control must be considered.

Rectal prolapse surgery in males and females: An ACS NSQIP-based comparative analysis of over 12,000 patients.

BACKGROUND: Rectal prolapse is relatively uncommon in male patients. The aim of this study was to compare males and females who underwent rectal prolapse surgery. STUDY DESIGN: Retrospective analysis of the ACS NSQIP public use file. RESULTS: Among 12,220 patients, 978 (8%) were male and 11,242 (92%) were female. Males were younger, 56 (38-73) vs. 71 (58-83) years, less often white (83% vs. 71%), had lower ASA scores, and underwent more laparoscopic (33% vs. 27%), more open (33% vs. 29%), and less perineal (33% vs 44%) procedures (all p < 0.05). Morbidity (9.9% vs. 10.0%), reoperation (3.4% vs. 3.1%), and readmission (5.7% vs. 6.0%) were not different for males and females. In subgroup analysis by surgical procedure type, there remained no outcome differences. Propensity matched analysis revealed no difference in the use of laparoscopic, open, or perineal procedures. CONCLUSIONS: Males with rectal prolapse are younger, have a different racial distribution, a lower surgical risk profile, and undergo different surgical procedures than females, which appears to be driven by patient age and surgical risk assessment.