Impact of neoadjuvant therapy on nodal harvest in clinical stage III rectal cancer: Establishing optimum cut-offs by disease response.

INTRODUCTION: A minimum lymph node harvest (LNH) of 12 is the current standard for appropriate nodal staging in resectable rectal cancer. However, the rise of neoadjuvant chemoradiation (NCRT) and total neoadjuvant therapy (TNT) has been associated with decreasing number of LNH. We hypothesize that as tumor response to neoadjuvant therapy increases, the optimum for LNH to achieve appropriate nodal staging should decrease. METHODS: Patients with clinical stage III rectal adenocarcinoma who underwent NCRT/TNT followed by resection were identified from the National Cancer Database. A JoinPoint regression analysis was used to determine the LNH for each tumor regression grade (TRG) category beyond which the rate of positive nodes does not significantly change. RESULTS: Thirteen thousand four hundred and twenty-six patients met inclusion criteria. Of these, 2406 (17.9%) achieved TRG 0 or ypT0 and 8210 (61.2%) achieved ypN0. Collectively, 2043 patients (15.2%) were reported to have a pathologic complete response (ypT0 ypN0). Positive pathologic nodes were found in 15%, 23%, 31%, 54%, and 53% as ypT stage increased from ypT0 to ypT4, respectively. Similarly, ypN+ rates were 15%, 36%, 41%, and 55% in TRG 0-3. No JoinPoint was identified for TRG 0, whereas inflection points were found at 6-10 nodes for TRG1 (p = 0.002) and TRG 2 (p = 0.016), and at 11-15 nodes for TRG 3. CONCLUSION: The benchmark of retrieving 12 nodes in resectable stage III rectal cancer is not consistently achieved after NCRT/TNT. We demonstrate that the LNH requirement to establish accurate pathologic nodal staging can vary depending on the tumor response to neoadjuvant therapies.

Fact or fiction? Does the position of the end-to-end (EEA) stapler spike matter for colorectal anastomoses using a double-stapled technique?

AIM: Surgeons often have strong opinions about how to perform colorectal anastomoses with little data to support variations in technique. The aim of this study was to determine if location of the end-to-end (EEA) stapler spike relative to the rectal transection line is associated with anastomotic integrity. METHOD: This study was a retrospective analysis of a quality collaborative database at a quaternary centre and regional hospitals. Patients with any left-sided colon resection with double-stapled anastomosis were included (December 2019 to August 2022). Our primary endpoint was a composite outcome including positive air insufflation test, incomplete anastomotic donut, or thin/eccentric donut. Our secondary endpoint was clinical leak. RESULTS: Overall, 633 patients were included and stratified by location of the stapler spike relative to the rectal transection line. Of note, 86 patients had an end-colon to anterior rectum ("reverse Baker") anastomosis with no crossing staple lines. The rates of the composite endpoint based on position of the stapler spike were 12.4% (anterior), 8.1% (through), 12.8% (posterior), 5.1% (corner), and 2.3% for the "reverse Baker" (p = 0.03). The overall rate of clinical leak was 3.8% and there were no differences between methods. In a multivariate analysis, the "reverse Baker" anastomosis was associated with decreased odds of poor anastomotic integrity when compared to anastomoses with crossing staple lines (OR 0.20, 95% CI: 0.05-0.87, p = 0.03). CONCLUSIONS: For anastomoses with crossing staple lines, the position of the stapler spike relative to the rectal staple line is not associated with differences in anastomotic integrity. In contrast, anastomoses with no crossing staple lines resulted in significantly lower rates of poor anastomotic integrity, but no difference in clinical leaks.

Colorectal Surgery Resident Participation in Screening Colonoscopies: How Does It Impact Quality?

BACKGROUND: Performing colonoscopies is an integral component of colorectal surgery residency training. There exists a paucity of literature regarding colonoscopy quality metrics with colorectal trainee involvement. OBJECTIVE: This study aimed to investigate the effect of colorectal surgery resident participation on quality metrics in screening colonoscopy. DESIGN: Screening colonoscopies performed between August 1, 2016, and July 31, 2018, were queried from a prospectively maintained institutional database. Data were cross-checked with resident case logs to verify colonoscopies with resident participation. SETTING: This study was conducted by the colorectal surgery department at a tertiary level hospital in the United States. PATIENTS: Consecutive, asymptomatic patients aged ≥45 years, undergoing screening colonoscopy, were selected. MAIN OUTCOME MEASURES: The quality parameters measured included overall, male, and female adenoma detection rates; total examination time; withdrawal time; cecal intubation rate; quality of bowel preparation; complications; and medication dosage. RESULTS: A total of 4594 patients were included in the study with a mean age of 60.5 ± 8.4 years (range, 45-91); 51.7% were women. Overall, 4186 of the colonoscopies were performed without resident participation, and 408 were performed with resident participation. Scope insertion, withdrawal, and total examination times were longer in the resident group. Cecal intubation rate, polypectomy rate, sex-specific and overall adenoma detection rates, and complication rates were similar between the groups. In the multivariate model, trainee involvement had no significant impact on adenoma detection rate. In addition, the trainee group utilized a higher mean dose of fentanyl. LIMITATIONS: The retrospective nature of the data with possible coding errors of the database and the inability to quantify the amount of resident participation and to clarify the degree of attending surgeon assistance and oversight were limitations of the study. CONCLUSIONS: Colorectal surgery resident participation in screening colonoscopy takes longer and appears safe, while achieving all national quality metrics without compromising adenoma detection rates. Changes in colonoscopy scheduling in regard to length of time may prove beneficial when there is resident participation. See Video Abstract at http://links.lww.com/DCR/B43. PARTICIPACIÓN DE LOS RESIDENTES DE CIRUGÍA COLORRECTAL EN COLONOSCOPIAS DE CRIBADO: ¿CÓMO AFECTA LA CALIDAD?: La realización de colonoscopias es un componente integral del entrenamiento de residencia en cirugía colorrectal. Existe una escasez de literatura con respecto a las medidas de calidad de la colonoscopia con la participación de los aprendices colorrectales.Investigar el efecto de la participación de residentes de cirugía colorrectal en las medidas de calidad en la colonoscopia de cribado.Las colonoscopias de cribado realizadas entre el 1 de agosto de 2016 y el 31 de julio de 2018 se consultaron desde una base de datos institucional mantenida prospectivamente. Los datos se cotejaron con registros de casos de residentes para verificar las colonoscopias con participación de residentes.Departamento de cirugía colorrectal en un hospital de tercer nivel de los Estados Unidos.Pacientes consecutivos, asintomáticos, edad ≥45 años, sometidos a colonoscopia de detección.Parámetros de calidad que incluyen tasas generales de detección de adenoma en hombres y mujeres, tiempo total de examen, tiempo de retiro, tasa de intubación cecal, calidad de la preparación intestinal, complicaciones y dosis de medicamentos.Se incluyeron un total de 4.594 pacientes en el estudio con una edad media de 60,5 ± 8,4 años (rango, 45-91) y 51,7% mujeres. En total 4,186 de las colonoscopias se realizaron sin participación de los residentes y 408 se realizaron con la participación de los residentes. Los tiempos de inserción, retiro y examen total del alcance fueron más largos en el grupo residentes. La tasa de intubación cecal, la tasa de polipectomía, las tasas de detección de adenoma específicos de género y generales, y las tasas de complicaciones fueron similares entre los grupos. En el modelo multivariado, la participación de los aprendices no tuvo un impacto significativo en la tasa de detección de adenoma. Además, el grupo de aprendices utilizó una dosis media más alta de fentanilo.Carácter retrospectivo de los datos con posibles errores de codificación de la base de datos. Incapacidad para cuantificar la cantidad de participación de los residentes y para aclarar el grado de asistencia y supervisión del cirujano.La participación de los residentes de cirugía colorrectal en la colonoscopia de cribado lleva más tiempo y parece segura, mientras se logran todas las medidas de calidad nacionales sin comprometer las tasas de detección de adenoma. Los cambios en la programación de la colonoscopia con respecto al período de tiempo pueden ser beneficiosos cuando hay participación de residentes. Vea el resumen del video en http://links.lww.com/DCR/B43.

Extended Venous Thromboembolism Prophylaxis After Elective Surgery for IBD Patients: Nomogram-Based Risk Assessment and Prediction from Nationwide Cohort.

BACKGROUND: Identification of risk factors for postoperative venous thromboembolism is an important step to reduce the morbidity associated with this potentially preventable complication after elective surgery for patients with IBD. OBJECTIVE: This study aimed to determine the risk factors for 30-day venous thromboembolism after abdominal surgery for patients with venous thromboembolism, identify potential indications for extended thromboprophylaxis, and develop a nomogram for prediction of risk. DESIGN: This is a retrospective cohort study from a prospectively collected database. SETTING: The American College of Surgeons National Surgical Quality Improvement Program Participant User File from 2005 to 2016 was used for data analysis. PATIENTS: All patients with IBD undergoing elective abdominopelvic bowel surgery were included. MAIN OUTCOME MEASURES: The primary outcomes were the incidence of in-hospital and postdischarge venous thromboembolism within 30 days of the index abdominopelvic surgery. RESULTS: A total of 24,182 patients met the inclusion criteria. Thirty-day total and postdischarge rates of venous thromboembolism were 2.5% (n = 614) and 1% (n =252). Forty-one percent (252/614) of venous thromboembolism events occurred after hospital discharge. Univariate analysis assessed 37 variables for association with study outcomes. On multivariate logistic regression analysis, older age, steroid use, bleeding disorders, open surgery, hypertension, longer operative time, and preoperative hospitalization were associated with venous thromboembolism before discharge and also postoperative transfusion, steroid use, pelvic and enterocutaneous fistula surgery, and longer operative time were associated with venous thromboembolism after discharge. A nomogram was constructed for each outcome, translating multivariate model parameter estimates into a visual scoring system where the estimated probability of venous thromboembolism can be calculated. LIMITATIONS: This study was limited by its retrospective nature and the limitations inherent to a database. CONCLUSION: Given the higher risk of venous thromboembolism in patients with IBD after elective abdominopelvic surgery compared with other indications, an accurate prediction of venous thromboembolism before and after discharge using the proposed nomogram can facilitate decision making for individualized extended thromboprophylaxis in the preoperative setting as a screening tool. See Video Abstract at http://links.lww.com/DCR/A711.

The American Society of Colon and Rectal Surgeons Assessment Tool for Performance of Laparoscopic Colectomy.

BACKGROUND: The lack of consensus for performance assessment of laparoscopic colorectal resection is a major impediment to quality improvement. OBJECTIVE: The purpose of this study was to develop and assess the validity of an evaluation tool for laparoscopic colectomy that is feasible for wide implementation. DESIGN: During the pilot phase, a small group of experts modified previous assessment tools by watching videos for laparoscopic right colectomy with the following categories of experience: novice (less than 20 cases), intermediate (50-100 cases), and expert (more than 500 cases). After achieving sufficient reliability (κ > 0.8), a user-friendly tool was validated among a large group of blinded, trained experts. SETTING: The study was conducted through the American Society of Colon and Rectal Surgeons Operative Competency Evaluation Committee. PATIENTS: Raters were from the Operative Competency Evaluation Committee of the American Society of Colon and Rectal Surgeons. MAIN OUTCOME MEASURES: Assessment tool reliability and internal consistency were measured. RESULTS: From October 2014 through February 2015, 4 groups of 5 raters blinded to surgeon skill level evaluated 6 different laparoscopic right colectomy videos (novice = 2, intermediate = 2, expert = 2). The overall Cronbach α was 0.98 (>0.9 = excellent internal consistency). The intraclass correlation for the overall assessment was 0.93 (range, 0.77-0.93) and was >0.74 (excellent) for each step. The average scores (scale, 1-5) for experts were significantly better than those in the intermediate category, with a mean (SD) of 4.51 (0.56) versus 2.94 (0.56; p = 0.003). Videos in the intermediate group scored more favorably than beginner videos for each individual step and overall performance (mean (SD) = 3.00 (0.32) vs 1.78 (0.42); p = 0.006). LIMITATIONS: The study was limited by rater bias to technique and style. CONCLUSIONS: The unique and robust methodology in this trial produced an assessment tool that was feasible for raters to use when assessing videotaped laparoscopic right hemicolectomies. The potential applications for this new tool are widespread, including both training and evaluation of competence at the attending level. See Video Abstract at http://links.lww.com/DCR/A369, http://links.lww.com/DCR/A370, http://links.lww.com/DCR/A371.

Laparoscopic colectomy in the obese, morbidly obese, and super morbidly obese: when does weight matter?

PURPOSE: Previous studies have demonstrated that obese patients (BMI >30) undergoing laparoscopic colectomy have longer operative times and increased complications when compared to non-obese cohorts. However, there is little data that specifically evaluates the outcomes of obese patients based on the degree of their obesity. The aim of this study was to evaluate the impact of increasing severity of obesity on patients undergoing laparoscopic colectomy. METHODS: A retrospective review was performed of all patients undergoing laparoscopic colectomy between 1996 and 2013. Patients were classified according to their BMI as obese (BMI 30.0-39.9), morbidly obese (BMI 40.0-49.9), and super obese (BMI >50). Main outcome measures included conversion rate, operative time, estimated blood loss, post-operative complications, and length of stay. RESULTS: There were 923 patients who met inclusion criteria. Overall, 604 (65.4%), 257 (27.9%), and 62 (6.7%) were classified as obese (O), morbidly obese (MO), and super obese (SO), respectively. Clinicopathologic characteristics were similar among the three groups. The SO group had significantly higher conversion rates (17.7 vs. 7 vs. 4.8%; P = 0.031), longer average hospital stays (7.1 days vs. 4.9 vs. 3.4; P = 0.001), higher morbidity (40.3 vs. 16.3 vs. 12.4%; P = 0.001), and longer operative times (206 min vs. 184 vs. 163; P = 0.04) compared to the MO and O groups, respectively. The anastomotic leak rate in the SO (4.8%; P = 0.027) and MO males (4.1%; P = 0.033) was significantly higher than MO females (2.2%) and all obese patients (1.8%). CONCLUSION: Increasing severity of obesity is associated with worse perioperative outcomes following laparoscopic colectomy.

Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use?

BACKGROUND: Postoperative ileus (POI) is a major cause of morbidity, increased length of stay (LOS) and hospital cost after colorectal surgery. Alvimopan is a µ-opioid antagonist used to accelerate upper and lower gastrointestinal function after bowel resection. We hypothesized that alvimopan would reduce LOS in patients undergoing colorectal resection with stoma, a situation that has not been evaluated. METHODS: A retrospective review (2010-2015) identified 58 patients who underwent colorectal resection for benign or malignant disease with stoma creation and received alvimopan. They were case-matched to 58 non-alvimopan patients based on age, BMI, baseline comorbidities, stoma type created and surgical approach. We compared overall LOS, incidence of POI and other postoperative complications. RESULTS: There were equal numbers of laparoscopic (N = 18) and open resections (N = 40) in the alvimopan group and non-alvimopan group. There were also equal numbers of patients with an ileostomy (N = 37) or colostomy (N = 21) in each group. Overall, 41 patients underwent resection for malignant disease in the alvimopan group compared to 37 in the non-alvimopan group. There was a significant reduction in median LOS overall (alvimopan 5 (4-7) versus control 6 (4.75-9.25) days, P = 0.03). While the 6-day median LOS was similar for patients undergoing ileostomy creation (P = 0.25), alvimopan patients had a 3-day decreased median LOS that approached statistical significance (P = 0.06). The overall 30-day complication rate was higher in the control group (41.4 vs. 51.7%, P = 0.26), but the readmission rate within 30 days was higher in the alvimopan group (19 vs. 13.8%, P = 0.45). Neither of these differences reached statistically significance. CONCLUSION: The use of alvimopan in patients undergoing colorectal resection with stoma is associated with a significantly shorter LOS, but the increased readmission rate warrants further study. Based on these data, alvimopan should be evaluated in a controlled setting for patients undergoing colorectal resection with colostomy creation.

Failing to Prepare Is Preparing to Fail: A Single-Blinded, Randomized Controlled Trial to Determine the Impact of a Preoperative Instructional Video on the Ability of Residents to Perform Laparoscopic Right Colectomy.

BACKGROUND: Laparoscopic colorectal resection is an index case for advanced skills training, yet many residents struggle to reach proficiency by graduation. Current methods to reduce the learning curve for residents remain expensive, time consuming, and poorly validated. OBJECTIVE: The purpose of this study was to assess the impact of the addition of a preprocedural instructional video to improve the ability of a general surgery resident to perform laparoscopic right colectomy when compared with standard preparation. DESIGN: This was a single-blinded, randomized control study. SETTINGS: Four university-affiliated teaching hospitals were included in the study. PARTICIPANTS: General surgery residents in postgraduation years 2 through 5 participated. INTERVENTION: Residents were randomly assigned to preparation with a narrated instructional video versus standard preparation. MAIN OUTCOME MEASURES: Resident performance, scored by a previously validated global assessment scale, was measured. RESULTS: Fifty-four residents were included. Half (n = 27) were randomly assigned to view the training video and half (n = 27) to standard preparation. There were no differences between groups in terms of training level or previous operative experience or in patient demographics (all p > 0.05). Groups were similar in the percentage of the case completed by residents (p = 0.39) and operative time (p = 0.74). Residents in the video group scored significantly higher in total score (mean: 46.8 vs 42.3; p = 0.002), as well as subsections directly measuring laparoscopic skill (vascular control mean: 11.3 vs 9.7, p < 0.001; mobilization mean: 7.6 vs. 7.0, p = 0.03) and overall performance score (mean: 4.0 vs 3.1; p < 0.001). Statistical significance persisted across training levels. LIMITATIONS: There is potential for Hawthorne effect, and the study is underpowered at the individual postgraduate year level. CONCLUSIONS: The simple addition of a brief, narrated preprocedural video to general surgery resident case preparation significantly increased trainee ability to successfully perform a laparoscopic right colectomy. In an era of shortened hours and less exposure to cases, incorporating a brief but effective instructional video before surgery may improve the learning curve of trainees and ultimately improve safety.

Prospective Case Series of a Novel Minimally Invasive Bipolar Coagulation System in the Treatment of Grade I and II Internal Hemorrhoids.

Background Existing nonsurgical procedures for the treatment of grade I and II internal hemorrhoids are often painful, technically demanding, and often necessitate multiple applications. This study prospectively assessed the safety and efficacy of the HET Bipolar System, a novel minimally invasive device, in the treatment of symptomatic grade I and II internal hemorrhoids. Methods Patients with symptomatic grade I or II internal hemorrhoids despite medical management underwent hemorrhoidal ligation with the HET Bipolar System. Endpoints included resolution or improvement of hemorrhoidal bleeding and/or prolapse from baseline, recurrent or refractory symptoms, and pain. Results Twenty patients were treated with the HET Bipolar System. Two were lost to follow-up. Refractory or recurrent bleeding was present in 8 of 18 (44.4%), 4 of 11 (36.4%), and 4 of 8 (50.0%) patients, and prolapse was reported by 1 of 18 (5.6%), 4 of 11 (36.4%), and 1/7 (14.3%) of patients at 1, 3, and 6 months, respectively. Bleeding improved from baseline in 88.2%, 81.8%, and 87.5% of patients, and resolution of baseline prolapse was seen in 11 of 11 (100%), 4 of 7 (57.1%), and 5 of 5 (100%) patients at the same intervals. Thirteen of 18 (72.2%) patients did not require additional treatment for their symptoms. Conclusions The HET Bipolar System is safe and easy to use with short-term effectiveness comparable to that of currently used techniques for the treatment of symptomatic grade I and II internal hemorrhoids. It may be an effective alternative to rubber band ligation in patients with larger internal hemorrhoids and those with hemorrhoids close to the dentate line in which banding may produce debilitating pain.

High-resolution anoscopy or expectant management for anal intraepithelial neoplasia for the prevention of anal cancer: is there really a difference?

BACKGROUND: High-resolution anoscopy has been shown to improve identification of anal intraepithelial neoplasia but a reduction in progression to anal squamous-cell cancer has not been substantiated when serial high-resolution anoscopy is compared with traditional expectant management. OBJECTIVE: The aim of this study was to compare high-resolution anoscopy versus expectant management for the surveillance of anal intraepithelial neoplasia and the prevention of anal cancer. DESIGN: This is a retrospective review of all patients who presented with anal squamous dysplasia, positive anal Pap smears, or anal squamous-cell cancer from 2007 to 2013. SETTING: This study was performed in the colorectal department of a university-affiliated, tertiary care hospital. PATIENTS: Included patients had biopsy-proven anal intraepithelial neoplasia from 2007 to 2013. INTERVENTIONS: Patients were treated with high-resolution anoscopy with ablation or standard anoscopy with ablation. Both groups were treated with imiquimod and followed every 6 months indefinitely. MAIN OUTCOME MEASURES: The incidence of anal squamous-cell cancer in each group was the primary end point. RESULTS: From 2007 to 2013, 424 patients with anal squamous dysplasia were seen in the clinic (high-resolution anoscopy, 220; expectant management, 204). Three patients (high-resolution anoscopy, 1; expectant management, 2) progressed to anal squamous-cell cancer; 2 were noncompliant with follow-up and with HIV treatment, and the third was allergic to imiquimod and refused to take topical 5-fluorouracil. The 5-year progression rate was 6.0% (95% CI, 1.5-24.6) for expectant management and 4.5% (95% CI, 0.7-30.8) for high-resolution anoscopy (p = 0.37). LIMITATIONS: This was a retrospective review. There is potential for selection and referral bias. Because of the rarity of the outcome, the study may be underpowered. CONCLUSIONS: Patients with squamous-cell dysplasia followed with expectant management or high-resolution anoscopy rarely develop squamous-cell cancer if they are compliant with the protocol. The cost, morbidity, and value of high-resolution anoscopy should be further evaluated in lieu of these findings.

Novel operative anoscope for Ferguson hemorrhoidectomy: a feasibility study and comparative cohort analysis.

BACKGROUND: Operative hemorrhoidectomy can result in pain and altered continence from excessive excision of anoderm or surrounding tissue. We assessed a novel low-profile slotted anoscope to determine if the device would promote safe dissection, lessen trauma, and reduce operative times for hemorrhoidectomy. METHODS: Patients requiring hemorrhoidectomy (June 2008 - January 2010) underwent a prospective phase-2 trial evaluating a new operating anoscope (CAD, Ethicon Endosurgery, Cincinnati, OH). Demographics and perioperative end points including bleeding, pain, fecal incontinence, stenosis, and symptom recurrence were analyzed at 4 weeks, 3 months, 6 months, and 1 year postoperatively. We compared these to patients undergoing hemorrhoidectomy (February 2010 - November 2012) with a traditional Hill-Ferguson anoscope (THF). RESULTS: 40 patients (CAD, 20 vs THF, 20) were included. Presenting symptoms were similar, whereas mean duration of symptoms was longer for CAD (41.2 ± 8.4 vs 27 ± 9.5 months; P < .05). Estimated blood loss was lower for CAD [8.3 mL (range = 2-40 mL) vs 11.3 mL THF (range = 5-35 mL; P = .87)]. Mean operative times were lower for the CAD than the THF group (15.6 ± 3.4 vs 26.1 ± 4.1 minutes; P < .05). Visual analog pain scores were non-significantly increased in the THF group at 4 weeks (P = .23). At 3 months, 6 months, and 1 year, there was no difference in continence. CONCLUSION: The CAD anoscope reduced operative times for modified Ferguson (closed) hemorrhoidectomy when compared with traditional retractors. There was no difference in incontinence or pain between groups.

Cost-effectiveness of laparoscopy in rectal cancer.

BACKGROUND: There is an increasing trend to use laparoscopy for rectal cancer surgery. Although laparoscopic and open rectal resections appear oncologically equivalent, there is little information on the cost of different surgical approaches. With the current health care crisis and the importance of optimizing health care resources and patient outcomes, the cost of care is an important factor. OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of laparoscopy in rectal cancer. DESIGN: This was a case-matched study. SETTINGS: This study was conducted at a tertiary referral center. PATIENTS: Patients undergoing elective rectal cancer resection between 2007 and 2012 were selected. METHODS: A review of a prospective database for elective laparoscopic rectal cancer resections was performed. Laparoscopic cases were matched to open cases based on age, BMI, operative procedure, and diagnostic-related group. MAIN OUTCOME MEASURES: The primary outcomes measured were the cost of care, hospital length of stay, discharge disposition, readmission, postoperative complications, and mortality rates. RESULTS: Two hundred fifty-four matched cases were included in the analysis: 125 laparoscopic (49%) and 129 open (51%). The cTNM stage (p = 0.39), tumor distance from the anal verge (p = 0.07), and rate of neoadjuvant therapy received between the laparoscopic and open groups were similar (p = 0.12). Operating time (p< 0.01) and cost per operating room minute (p = 0.04) were significantly higher in the open group. The groups were oncologically equivalent, based on circumferential resection margin (p = 0.15). The laparoscopic group had a significantly shorter length of stay (p < 0.01) and lower total hospital cost (p < 0.01). Postoperative complications, 30-day readmission, reoperation, and mortality rates were similar. However, significantly more patients undergoing open resection required intensive care unit care (p = 0.03), skilled nursing (p = 0.03), or home care services (p < 0.01) at discharge. LIMITATIONS: This investigation was conducted at a single institution and it is a retrospective study with potential bias. CONCLUSIONS: Laparoscopy is cost-effective for rectal cancer surgery, improving both health care expenditures and patient outcomes. For selected patients, laparoscopic rectal cancer resection can reduce length of stay, operating time, and resource utilization.

Crohn's disease and pregnancy: the impact of perianal disease on delivery methods and complications.

BACKGROUND: The optimal delivery method in patients with Crohn's disease is unknown, and there is no large-scale evidence on which to base decisions. OBJECTIVE: The aim of this study was to compare delivery methods and outcomes in patients with and without Crohn's disease. DESIGN AND PATIENTS: The Nationwide Inpatient Sample and International Classification of Diseases, Ninth Revision codes were used to identify childbirth deliveries. Patients were stratified by the presence or absence of Crohn's disease and perianal disease (anorectal fistula or abscess, rectovaginal fistula, anal fissure, and anal stenosis). SETTINGS: A large population-cohort database was used for the analysis. MAIN OUTCOME MEASURES: The primary outcomes measured were cesarean delivery and perineal lacerations. RESULTS: Of 6,794,787 pregnant women who delivered, 2882 had a diagnosis of Crohn's disease. Rates of cesarean delivery were higher in patients who had Crohn's disease with (83.1%) and without (42.8%) perianal disease in comparison with patients who did not have Crohn's disease with (38.9%) and without (25.6%) perianal disease (p < 0.001). Rates of 4th degree perineal lacerations were similar between patients who had or did not have Crohn's disease without perianal disease (1.4% vs 1.3%), but these rates increased significantly in patients with perianal disease (12.3%, p < 0.001). On multivariate analysis, perianal disease (OR, 10.9; 95% CI, 8.3-4.1; p < 0.001) and smoking (OR, 1.6; 95% CI, 1.5-1.7; p < 0.001) were independently associated with higher rates of 4th degree laceration. Crohn's disease was not independently associated with 4th degree laceration. LIMITATIONS: This was a retrospective study with the inherent limitations of large databases. CONCLUSIONS: Patients with Crohn's disease have higher rates of cesarean delivery. Perianal disease predicts severe perineal laceration independent of the presence of Crohn's disease. In the absence of perianal disease, the method of delivery in women with Crohn's disease should be predicated on obstetric indication.

Virtual reality simulator training for laparoscopic colectomy: what metrics have construct validity?

BACKGROUND: Virtual reality simulation for laparoscopic colectomy has been used for training of surgical residents and has been considered as a model for technical skills assessment of board-eligible colorectal surgeons. However, construct validity (the ability to distinguish between skill levels) must be confirmed before widespread implementation. OBJECTIVE: This study was designed to specifically determine which metrics for laparoscopic sigmoid colectomy have evidence of construct validity. DESIGN: General surgeons that had performed fewer than 30 laparoscopic colon resections and laparoscopic colorectal experts (>200 laparoscopic colon resections) performed laparoscopic sigmoid colectomy on the LAP Mentor model. All participants received a 15-minute instructional warm-up and had never used the simulator before the study. Performance was then compared between each group for 21 metrics (procedural, 14; intraoperative errors, 7) to determine specifically which measurements demonstrate construct validity. Performance was compared with the Mann-Whitney U-test (p < 0.05 was significant). RESULTS: Fifty-three surgeons; 29 general surgeons, and 24 colorectal surgeons enrolled in the study. The virtual reality simulators for laparoscopic sigmoid colectomy demonstrated construct validity for 8 of 14 procedural metrics by distinguishing levels of surgical experience (p < 0.05). The most discriminatory procedural metrics (p < 0.01) favoring experts were reduced instrument path length, accuracy of the peritoneal/medial mobilization, and dissection of the inferior mesenteric artery. Intraoperative errors were not discriminatory for most metrics and favored general surgeons for colonic wall injury (general surgeons, 0.7; colorectal surgeons, 3.5; p = 0.045). LIMITATIONS: Individual variability within the general surgeon and colorectal surgeon groups was not accounted for. CONCLUSIONS: The virtual reality simulators for laparoscopic sigmoid colectomy demonstrated construct validity for 8 procedure-specific metrics. However, using virtual reality simulator metrics to detect intraoperative errors did not discriminate between groups. If the virtual reality simulator continues to be used for the technical assessment of trainees and board-eligible surgeons, the evaluation of performance should be limited to procedural metrics.

The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial.

BACKGROUND: Superior early pain control has been suggested with transversus abdominis plane blocks, but evidence-based recommendations for transversus abdominis plane blocks and their effects on patient outcomes are lacking. OBJECTIVE: The aim of this study was to determine whether transversus abdominis plane blocks improve early postoperative outcomes in patients undergoing laparoscopic colorectal resection already on an optimized enhanced recovery pathway. DESIGN: This study is based on a prospective, randomized, double-blind controlled trial. SETTINGS: The trial was conducted at a tertiary referral center. PATIENTS: Patients undergoing elective laparoscopic colorectal resection were selected. INTERVENTIONS(S): Patients were randomly assigned to receive either a transversus abdominis plane block or a placebo placed intraoperatively under laparoscopic guidance. All followed a standardized enhanced recovery pathway. Patient demographics, perioperative procedures, and postoperative outcomes were collected. MAIN OUTCOME MEASURES: Postoperative pain and nausea/vomiting scores in the postanesthesia care unit and department, opioid use, length of stay, and 30-day readmission rates were measured. RESULTS: The trial randomly assigned 41 patients to the transversus abdominis plane block group and 38 patients to the control group. Demographic, clinical, and procedural data were not significantly different. In the postanesthesia care unit, the transversus abdominis plane block group had significantly lower pain scores (p < 0.01) and used fewer opioids (p < 0.01) than the control group; postoperative nausea/vomiting scores were comparable (p = 0.99). The transversus abdominis plane group had significantly lower pain scores on postoperative day 1 (p = 0.04) and throughout the study period (p < 0.01). There was no significant difference between groups in postoperative opioid use (p = 0.65) or nausea/vomiting (p = 0.79). The length of stay (median, 2 days experimental, 3 days control; p = 0.50) and readmission rate (7% experimental, 5% control, p = 0.99) was similar across cohorts. LIMITATIONS: This study was conducted a single center. CONCLUSIONS: Transversus abdominis plane blocks improved immediate short-term opioid use and pain outcomes. Pain improvement was durable throughout the hospital stay. However, the blocks did not translate into less overall narcotic use, shorter length of stay, or lower readmission rates.

The impact of pregnancy on surgical Crohn disease: an analysis of the Nationwide Inpatient Sample.

BACKGROUND: The impact of pregnancy on the course of Crohn disease is largely unknown. Retrospective surveys have suggested a variable effect, but there are limited population-based clinical data. We hypothesized pregnant women with Crohn disease will have similar rates of surgical disease as a nonpregnant Crohn disease cohort. MATERIAL AND METHODS: International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify female Crohn patients from all patients admitted using the Nationwide Inpatient Sample (1998-2009). Women were stratified as either pregnant or nonpregnant. We defined Crohn-related surgical disease as peritonitis, gastrointestinal hemorrhage, intra-abdominal abscess, toxic colitis, anorectal suppuration, intestinal-intestinal fistulas, intestinal-genitourinary fistulas, obstruction and/or stricture, or perforation (excluding appendicitis). RESULTS: Of the 92,335 women admitted with a primary Crohn-related diagnosis, 265 (0.3%) were pregnant. Pregnant patients were younger (29 versus 44 y; P<0.001) and had lower rates of tobacco use (6% versus 13%; P<0.001). Pregnant women with Crohn disease had higher rates of intestinal-genitourinary fistulas (23.4% versus 3.0%; P<0.001), anorectal suppuration (21.1% versus 4.1%; P<0.001), and overall surgical disease (59.6% versus 39.2%; P<0.001). On multivariate logistic regression analysis controlling for malnutrition, smoking, age, and prednisone use, pregnancy was independently associated with higher rates of anorectal suppuration (odds ratio [OR], 5.2; 95% confidence interval [CI], 3.8-7.0; P<0.001), intestinal-genitourinary fistulas (OR, 10.4; 95% CI, 7.8-13.8; P<0.001), and overall surgical disease (OR, 2.9; 95% CI, 2.3-3.7; P<0.001). CONCLUSIONS: Pregnancy in women with Crohn disease is a significant risk factor for Crohn-related surgical disease, in particular, anorectal suppuration and intestinal-genitourinary fistulas.

Laparoscopic and converted approaches to rectal cancer resection have superior long-term outcomes: a comparative study by operative approach.

BACKGROUND AND OBJECTIVES: The goal of this study was to evaluate outcomes for rectal cancer resection by operative approach. Our hypothesis is that laparoscopic (LAP) and LAP converted to open (OPEN) rectal cancer resections have excellent patient and oncologic outcomes. METHODS: Review of a prospective database identified curative rectal cancer resections. Patients were stratified by operative approach: LAP, OPEN, or CONVERTED. Oncologic and clinical outcomes data was examined for each operative approach. RESULTS: Overall, 294 patients were analyzed-116 LAP (39.5%), 153 OPEN (52.0%), and 25 (8.5%) CONVERTED. Groups were comparable in demographics. Mean distal margin, circumferential resection margin, and lymph nodes harvested were comparable. The median length of stay was 4 days (range 1-20) LAP, 6 days (range 3-13) CONVERTED, and 8 days (range 1-35) OPEN (p < 0.01). More OPEN had postoperative complications (p < 0.01)-complication rates were 43.8% OPEN, 32.0% CONVERTED, and 21.5 % LAP. Unplanned readmissions and reoperations were similar (21.6% OPEN, 16.0% CONVERTED, 12.1% LAP). Overall 3-year disease-free survival (DFS) was 98.3%, and local recurrence rate was 2.0%. By approach, DFS was 100% CONVERTED, 93.1% LAP, and 87.6% OPEN (p = 0.31). Overall survival (OS) was 100 % CONVERTED, 99.1% LAP, and 97.4%. OPEN. Local recurrence was 0% CONVERTED, 2% OPEN, and 2.6% LAP. 3-year DFS for LAP and CONVERTED was superior to OPEN (p = 0.05), with comparable local recurrence (p = 0.07) and OS rates (0.43). CONCLUSIONS: LAP and converted procedures have comparable or superior clinical and oncologic outcomes. More procedures should be approached through a LAP approach. If the procedure cannot be completed laparoscopically, outcomes are not compromised for converted patients.

Predicting who will fail early discharge after laparoscopic colorectal surgery with an established enhanced recovery pathway.

BACKGROUND: Despite using laparoscopy and enhanced recovery pathways (ERP), some patients are not ready for early discharge. The goal of this study was to identify predictors for patients who might fail early discharge, so that any defined factors might be addressed and optimized. METHODS: A prospectively maintained database was reviewed for major elective laparoscopic colorectal surgical procedures. Cases were divided into day of discharge groups: ≤ 3 days and >4 days. All followed a standardized ERP. Demographic and clinical data were compared using Student's paired t tests or Fisher's exact test, with p value < 0.05 statistically significant. Regression analysis was performed to identify significant variables. RESULTS: There were 275 ≤ 3 days patients and 273 >4 days patients. There were significant differences between groups in body mass index (p = 0.0123), comorbidities (p = 0.0062), ASA class (p = 0.0014), operation time (p < 0.001), postoperative complications (p < 0.001), and 30-day reoperation rate (p = 0.0004). There were no significant differences for intraoperative complications (p = 0.724), readmissions (p = 0.187), or mortality rate (p = 1.00). Significantly more patients were discharged directly home in the ≤ 3-days cohort. Using logistic regression, every hour of operating time increased the risk of length of stay >4 days by 2.35 %. CONCLUSIONS: Elective colorectal surgery patients with longer operation times and more comorbidities are more likely to fail early discharge. These patients should have different expectations of the ERP, as an expected 1- to 3-day stay may not be achievable. By identifying patients at risk for failing early discharge, resources and postoperative support can be better allocated and patients better informed about likely recovery.

Close margin of adverse histologic factors with a negative primary tumor margin is not associated with increased locoregional recurrence in colon cancer.

PURPOSE: Locoregional recurrence after resection of colon cancer is increased when primary tumor margin is positive (<1 â€‹mm). Data is limited regarding the risk of locoregional recurrence with close margin (<1 â€‹mm) of histologic factors, such as intravascular tumor, intranodal tumor, tumor deposits, or extranodal extension. We hypothesized that close margin of these factors doesn't affect locoregional recurrence. METHODS: A retrospective review of all colon cancer surgical resections for adenocarcinoma from 2007 to 2020 was performed. Inclusion criteria were specimens with a negative primary tumor margin but a close margin of adverse histologic factors, defined as intravascular tumor, intranodal tumor, tumor deposits, or extranodal extension within 1 â€‹mm of a mesenteric or circumferential margin. RESULTS: Among 4435 pathology reports reviewed, 45 (1 â€‹%) of cases met inclusion criteria. Average follow-up was 38 months. The adverse histologic factor was identified as intranodal tumor in 24 (53 â€‹%) cases, intravascular tumor in 8 (17.8 â€‹%), tumor deposits in 5 (11.1 â€‹%), and more than one pathologic feature in 6 (13.3 â€‹%). There were 9 (20 â€‹%) recurrences; 6 (13 â€‹%) had distant recurrences only, 2 (4 â€‹%) patients had locoregional recurrences only, and 1 (2 â€‹%) patient had both locoregional and distant recurrence. The adverse histologic factor in these three patients was intravascular in two and both intravascular and intranodal in one. CONCLUSION: Based on our results, we do not have evidence that the presence of intravascular tumor, intranodal tumor, tumor deposits, or extranodal extension within 1 â€‹mm of a mesenteric or circumferential margin is associated with increased risk of locoregional recurrence.

Pilot study evaluating the efficacy of AlloMEM™ for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy.

OBJECTIVE: This study was designed to evaluate the feasibility of AlloMEM™, a novel lyophililzed human peritoneal membrane, at peritoneal reconstitution, and decreasing adhesion formation after temporary loop ileostomy. METHODS: In a pilot study, ten patients had AlloMEM™ used during elective formation of a temporary diverting loop ileostomy for benign or malignant colorectal disease. A blinded investigator and the operating surgeon analyzed the change in adhesion formation and peritoneal remodelling using ileostomy mobilization time and a 5-point adhesion scale grading intra-abdominally and at the subcutaneous and fascial levels. RESULTS: The mean body mass index was 31 [standard deviation (SD) 5.6], and 40 % of patients had previous abdominal surgery. Ileostomies were reversed after a mean 14 weeks (SD 6.0). The mean ileostomy mobilization time was 27.2 min (SD 12.0). From baseline to ileostomy reversal, there were significant increases in adhesions at the subcutaneous (p = 0.0002) and fascial levels (p = 0.0024). The increased subcutaneous adhesions were associated with improved peritoneal remodeling. There was no significant increase in adhesions from baseline to ileostomy reversal at the intra-abdominal points (p = 0.9393) or around the ileostomy site (p = 0.6128). The median hospital length of stay was 2.6 days (range, 2-3). A single adverse event related to product packaging led to redesign of the packaging process. CONCLUSIONS: Use of AlloMEM™ in ileostomy closures suggested improvement in adhesions around the fascia and promotion of peritoneal remodeling. AlloMEM™ was safe, feasible, and easy to use in this pilot study. Comparative research is needed to assess the outcomes with this novel product.