ABSTRACT
AIM: There is significant practice variation with respect to the use of bowel preparation to reduce surgical site infection (SSI) following colon surgery. Although intravenous antibiotics + mechanical bowel preparation + oral antibiotics (IVA + MBP + OA) has been shown to be superior to IVA + MBP and IVA, there are insufficient high-quality data from randomized controlled trails (RCTs) that directly compare these options. This is an important question, because if IVA + OA has similar effectiveness to IVA + MBP + OA, mechanical bowel preparation can be safely omitted, and the associated side effects avoided. The aim of this work is to compare rates of SSI following IVA + OA + MBP (MBP) versus IVA + OA (OA) for elective colon surgery. METHOD: This is a multicentre, parallel, two-arm, noninferiority RCT comparing IVA + OA + MBP versus IVA + OA. The primary outcome is the overall rate of SSI 30 days following surgery. Secondary outcomes are length of stay and 30-day emergency room visit and readmission rates. The planned sample size is 1062 subjects with four participating high-volume centres. Overall SSI rates 30 days following surgery between the treatment groups will be compared using a general linear model. Secondary outcomes will be analysed with linear regression for continuous outcomes, logistic regression for binary outcomes and modified Poisson regression for count data. CONCLUSION: It is expected that IVA + OA will work similarly to IVA + MBP + OA and that this work will provide definitive evidence showing that MBP is not necessary to reduce SSI. This is highly relevant to both patients and physicians as it will have the potential to significantly change practice and outcomes following colon surgery in Canada and beyond.
Subject(s)
Anti-Bacterial Agents , Cathartics , Colon , Preoperative Care , Surgical Wound Infection , Humans , Surgical Wound Infection/prevention & control , Surgical Wound Infection/etiology , Surgical Wound Infection/epidemiology , Cathartics/therapeutic use , Cathartics/administration & dosage , Canada , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Preoperative Care/methods , Colon/surgery , Female , Antibiotic Prophylaxis/methods , Male , Administration, Oral , Elective Surgical Procedures/adverse effects , Equivalence Trials as Topic , Length of Stay/statistics & numerical data , Patient Readmission/statistics & numerical data , Randomized Controlled Trials as Topic , Middle Aged , AdultABSTRACT
AIM: There is ongoing debate about whether ileal pouch-anal anastomosis needs temporary diversion at the time of construction. Stomas may reduce risk for anastomotic leak (AL) but are also associated with complications, emergency department visits and readmissions. This treatment trade-off study aims to measure patients' preferences by assessing the absolute risk of AL and pouch failure (PF) they are willing to accept to avoid a diverting ileostomy. METHODS: Fifty-two patients with ulcerative colitis, with or without previous pouch surgery, from Mount Sinai Hospital, Toronto, participated in this study. Standardized interviews were conducted using the treatment trade-off threshold technique. An online anonymous survey was used to collect patient demographics. We measured the absolute increased risk in AL and PF that patients would accept to undergo modified two-stage surgery as opposed to traditional three-stage surgery. RESULTS: Thirty-two patients (mean age 38.7 ± 15.3) with previous surgery and 20 patients (mean age 39.5 ± 11.9) with no previous surgery participated. Patients were willing to accept an absolute increased leak rate of 5% (interquartile range 4.5%-15%) to avoid a diverting ileostomy. Similarly, patients were willing to accept an absolute increased PF rate of 5% (interquartile range 2.5%-10%). Younger patients, aged 21-29, had lower tolerance for PF, accepting an absolute increase of only 2% versus 5% for patients older than 30 (P = 0.01). CONCLUSION: Patients were willing to accept a 5% increased AL rate or PF rate to avoid a temporary diverting ileostomy. This should be taken into consideration when deciding between modified two- and three-stage pouch procedures.
Subject(s)
Anastomotic Leak , Colitis, Ulcerative , Colonic Pouches , Ileostomy , Patient Preference , Proctocolectomy, Restorative , Humans , Colitis, Ulcerative/surgery , Colitis, Ulcerative/psychology , Female , Male , Adult , Middle Aged , Patient Preference/statistics & numerical data , Ileostomy/methods , Ileostomy/adverse effects , Ileostomy/psychology , Proctocolectomy, Restorative/methods , Proctocolectomy, Restorative/adverse effects , Anastomotic Leak/etiology , Anastomotic Leak/prevention & control , Colonic Pouches/adverse effects , Surveys and Questionnaires , Patient-Centered CareABSTRACT
AIM: Venous thromboembolic events (VTEs) are relatively common adverse surgical complications. Extended VTE prophylaxis for 4 weeks is recommended after colorectal cancer surgery, but its use in inflammatory bowel disease surgery lacks high-quality evidence. This retrospective study aimed to assess and characterize VTEs within the first 30 days after ileal pouch-anal anastomosis (IPAA) procedures and subtotal colectomies (STCs) for ulcerative colitis (UC). METHODS: All patients who underwent IPAA for UC between 1 January 2017 and 31 December 2021 were included. VTE rates after IPAA, in-hospital or at-home occurrences, utilization of in-hospital thromboprophylaxis, and prescribed anticoagulant treatment were evaluated. Retrospectively, the same variables were analysed if patients of the cohort underwent STC before the IPAA construction. RESULTS: In all, 204 patients underwent IPAA (61.8% men, 73% laparoscopic), with an average hospital stay of 6.8 days. Among them, 116 patients underwent STC prior to IPAA. Thirteen patients (6.3%) experienced VTEs after IPAA, with 76.9% (10/13) of cases occurring during hospitalization and under adequate thromboprophylaxis. The VTE rate after STC was 10.3% (12/116), with 58.2% (7/12) occurring in hospital and under appropriate thromboprophylaxis. No reoperations or mortality were attributed to thrombotic events. The type and duration of anticoagulant treatment varied considerably. CONCLUSION: The VTE rate after IPAA for UC was 6.3%, with the majority of events occurring in hospital and under adequate thromboprophylaxis. These findings suggest that routine use of extended VTE prophylaxis in our cohort may not be supported. Further research is needed to clarify the optimal VTE prophylaxis strategy for inflammatory bowel disease surgery.
Subject(s)
Anticoagulants , Colitis, Ulcerative , Postoperative Complications , Proctocolectomy, Restorative , Venous Thromboembolism , Humans , Colitis, Ulcerative/surgery , Colitis, Ulcerative/complications , Retrospective Studies , Female , Male , Venous Thromboembolism/prevention & control , Venous Thromboembolism/etiology , Adult , Proctocolectomy, Restorative/adverse effects , Proctocolectomy, Restorative/methods , Anticoagulants/therapeutic use , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Middle Aged , Colectomy/adverse effects , Colectomy/methods , Length of Stay/statistics & numerical dataABSTRACT
AIM: The aim of this study was to compare modified 2-stage and 3-stage IPAA construction techniques to evaluate the effect of diverting loop ileostomy following completion proctectomy and IPAA for ulcerative colitis. In addition, our overall institutional experience was reviewed to describe long-term outcomes and changes in staging trends over time. METHODS: Our institutional database was searched to identify all cases of IPAA for ulcerative colitis between 1981 and 2018. Patient, pouch and outcome characteristics were abstracted. Primary study outcomes were the incidence of primary pouch failure and pouch-related sepsis. Failure was evaluated by Kaplan-Meier estimates of survival over time. The adjusted effect of pouch stage was evaluated using multivariable Cox and logistic regression models. Exploratory analysis evaluated the effect of stage on failure in the pouch related sepsis subgroup. RESULTS: A total of 2105 patients underwent primary IPAA over the study period. The 5, 10 and 20-year pouch survival probabilities were 95.2%, 92.7% and 86.6%. The incidence of pouch related sepsis was 12.3%. Adjusted analysis demonstrated no difference in pouch failure (HR = 0.64: 95% 0.39-1.07, p = 0.09) or post-operative sepsis (aOR = 0.79: 95% CI 0.53-1.17, p = 0.24) by stage of construction. Among patients experiencing pouch sepsis, there was no difference in Kaplan-Meier estimates of pouch survival by stage (p = 0.90). CONCLUSIONS: Pouch related sepsis and IPAA failure did not differ between modified 2-stage and 3-stage construction techniques. Among the sub-group of patients experiencing pouch related sepsis, there was no difference in failure between groups. The results suggest diverting ileostomy may be safely avoided following delayed pouch reconstruction in appropriately selected patients.
Subject(s)
Colitis, Ulcerative , Colonic Pouches , Proctocolectomy, Restorative , Sepsis , Humans , Colitis, Ulcerative/surgery , Colitis, Ulcerative/complications , Proctocolectomy, Restorative/adverse effects , Proctocolectomy, Restorative/methods , Incidence , Rectum/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Sepsis/epidemiology , Sepsis/etiology , Sepsis/prevention & control , Colonic Pouches/adverse effects , Retrospective Studies , Treatment OutcomeABSTRACT
Tumor budding (TB) is a powerful prognostic factor in colorectal cancer (CRC). An internationally standardized method for its assessment (International Tumor Budding Consensus Conference [ITBCC] method) has been adopted by most CRC pathology protocols. This method requires that TB counts are reported by field area (0.785 mm 2 ) rather than objective lens and a normalization factor is applied for this purpose. However, the validity of this approach is yet to be tested. We sought to validate the ITBCC method with a particular emphasis on normalization as a tool for standardization. In a cohort of 365 stage I-III CRC, both normalized and non-normalized TB were significantly associated with disease-specific survival and recurrence-free survival ( P <0.0001). Examining both 0.95 and 0.785 mm 2 field areas in a subset of patients (n=200), we found that normalization markedly overcorrects TB counts: Counts obtained in a 0.95 mm 2 hotspot field were reduced by an average of 17.5% following normalization compared with only 3.8% when counts were performed in an actual 0.785 mm 2 field. This resulted in 45 (11.3%) cases being downgraded using ITBCC grading criteria following normalization, compared with only 5 cases (1.3%, P =0.0007) downgraded when a true 0.785 mm 2 field was examined. In summary, the prognostic value of TB was retained regardless of whether TB counts in a 0.95 mm 2 field were normalized. Normalization resulted in overcorrecting TB counts with consequent downgrading of most borderline cases. This has implications for risk stratification and adjuvant treatment decisions, and suggests the need to re-evaluate the role of normalization in TB assessment.
Subject(s)
Colorectal Neoplasms , Humans , Neoplasm Staging , Prognosis , Neoplasm Grading , Colorectal Neoplasms/pathology , ConsensusABSTRACT
BACKGROUND: Transanal IPAA is a relatively new technique aiming to reduce surgical invasiveness while providing better access to the pelvis in patients with ulcerative colitis. Currently, patients' preference for a surgical approach has never been investigated. OBJECTIVE: To observe patient preference between transanal and laparoscopic IPAA by measuring the potential risk, expressed in pouch function reduction, patients are willing to take to undergo transanal surgery. DESIGN: We conducted standardized interviews of patients using the threshold technique. SETTINGS: Patients from Mount Sinai Hospital in Toronto were included. PATIENTS: Fifty-two patients with ulcerative colitis participated in this study. INTERVENTION: Patients with ulcerative colitis, with or without previous pouch surgery, were submitted to standardized interviews using the threshold technique. MAIN OUTCOME MEASURES: We measured the absolute increase in bowel frequency, bowel urgency, and fecal incontinence that patients would accept if undergoing transanal IPAA. RESULTS: Thirty-two patients (mean age: 38.7 ± 15.3 years) with previous surgery and 20 patients (mean age: 39.5 ± 11.9 years) with no previous surgery participated in this study. Patients accepted an absolute increase of 2 bowel movements per day and 1 episode of fecal incontinence per month to undergo transanal IPAA. They also accepted 10 minutes of worsening bowel urgency (ie, decrease of 10 minutes in "holding time") for transanal surgery. Younger patients aged 21 to 29 years only accepted an absolute decrease of 5 minutes in "holding time" ( p = 0.02). LIMITATIONS: Biases inherent to study design. CONCLUSIONS: Patients were willing to accept a potential reduction in pouch function to receive the less invasive method of transanal IPAA. More studies evaluating long-term functional outcomes after transanal IPAA are required to help patients make educated surgical decisions. See Video Abstract. ANASTOMOSIS LAPAROSCPICA VERSUS TRANSANAL ILEALBOLSA ANAL PARA LA COLITIS ULCEROSA UN ESTUDIO DE COMPENSACIN DE TRATAMIENTO CENTRADO EN EL PACIENTE: ANTECEDENTES:La anastomosis anal transanal con reservorio ileal es una técnica relativamente nueva que tiene como objetivo reducir la invasividad quirúrgica y al mismo tiempo proporcionar un mejor acceso a la pelvis en pacientes con colitis ulcerosa. Actualmente, nunca se ha investigado la preferencia de los pacientes sobre el abordaje quirúrgico.OBJETIVO:Observar la preferencia de los pacientes entre la anastomosis ileoanal con reservorio transanal y laparoscópica midiendo el riesgo potencial, expresado en la reducción de la función del reservorio, que los pacientes están dispuestos a someterse a una cirugía transanal.DISEÑO:Realizamos entrevistas estandarizadas de pacientes utilizando la técnica del umbral.AJUSTES:Se incluyeron pacientes del Hospital Mount Sinai en Toronto.PACIENTES:Cincuenta y dos pacientes con colitis ulcerosa participaron en este estudio.INTERVENCIÓN(ES):Los pacientes con colitis ulcerosa, con o sin cirugía previa de reservorio fueron sometidos a entrevistas estandarizadas utilizando la técnica del umbral.MEDIDAS DE RESULTADO PRINCIPALES:Medimos el aumento absoluto en la frecuencia intestinal, la urgencia intestinal y la incontinencia fecal que los pacientes aceptarían si se sometieran a una anastomosis transanal con bolsa ileal.RESULTADOS:Treinta y dos pacientes (edad media: 38,7 ± 15,3) con cirugía previa y 20 pacientes (edad media: 39,5 ± 11,9) sin cirugía previa participaron en este estudio. Los pacientes aceptaron un aumento absoluto de 2 deposiciones por día y un episodio de incontinencia fecal por mes para someterse a una anastomosis transanal ileoanal con reservorio. También aceptaron 10 minutos de empeoramiento de la urgencia intestinal (es decir, disminución de 10 minutos del "tiempo de espera") para la cirugía transanal. Los pacientes más jóvenes de 21 a 29 años solo aceptaron una disminución absoluta de 5 minutos en el "tiempo de espera" ( P = 0,02).LIMITACIONES:Sesgos inherentes al diseño del estudio.CONCLUSIONES:Los pacientes estaban dispuestos a aceptar una reducción potencial en la función del reservorio para recibir el método menos invasivo de anastomosis transanal ileoanal con reservorio. Se requieren más estudios que evalúen los resultados funcionales a largo plazo después de la anastomosis transanal ileoanal con reservorio para ayudar a los pacientes a tomar decisiones quirúrgicas informadas. (Traducción-Yesenia Rojas-Khalil ).
Subject(s)
Colitis, Ulcerative , Fecal Incontinence , Laparoscopy , Humans , Young Adult , Adult , Middle Aged , Colitis, Ulcerative/surgery , Fecal Incontinence/surgery , Retrospective Studies , Laparoscopy/adverse effects , Patient-Centered Care , Postoperative Complications/surgeryABSTRACT
BACKGROUND AND AIMS: Inflammatory bowel disease colitis-associated dysplasia is managed with either enhanced surveillance and endoscopic resection or prophylactic surgery. The rate of progression to cancer after a dysplasia diagnosis remains uncertain in many cases and patients have high thresholds for accepting proctocolectomy. Individualised discussion of management options is encouraged to take place between patients and their multidisciplinary teams for best outcomes. We aimed to develop a toolkit to support a structured, multidisciplinary and shared decision-making approach to discussions about dysplasia management options between clinicians and their patients. METHODS: Evidence from systematic literature reviews, mixed-methods studies conducted with key stakeholders, and decision-making expert recommendations were consolidated to draft consensus statements by the DECIDE steering group. These were then subjected to an international, multidisciplinary modified electronic Delphi process until an a priori threshold of 80% agreement was achieved to establish consensus for each statement. RESULTS: In all, 31 members [15 gastroenterologists, 14 colorectal surgeons and two nurse specialists] from nine countries formed the Delphi panel. We present the 18 consensus statements generated after two iterative rounds of anonymous voting. CONCLUSIONS: By consolidating evidence for best practice using literature review and key stakeholder and decision-making expert consultation, we have developed international consensus recommendations to support health care professionals counselling patients on the management of high cancer risk colitis-associated dysplasia. The final toolkit includes clinician and patient decision aids to facilitate shared decision-making.
Subject(s)
Colitis , Inflammatory Bowel Diseases , Neoplasms , Humans , Delphi Technique , Hyperplasia , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/therapy , Risk , Systematic Reviews as TopicABSTRACT
OBJECTIVE: A randomized controlled trial was conducted to evaluate the effect of a postdischarge app on 30-day readmissions and patient-reported outcomes following colorectal surgery. BACKGROUND: Patients undergoing colorectal surgery are particularly vulnerable during their transition from hospital-to-home. There has been increasing interest in e-health to provide cost-effective transitional care. An integrated discharge monitoring program using a mobile app platform was developed to support patients after surgery. METHODS: A 2 arm, superiority randomized control trial was conducted at an academic tertiary care center with patients undergoing elective colorectal surgery. The intervention group received usual postoperative care and postdischarge monitoring with the app. The primary outcome was 30-day readmissions following hospital discharge. RESULTS: Two hundred eighty-two participants were randomized. The majority were young, had inflammatory bowel disease and underwent laparoscopic surgery. Intention to treat analysis showed no difference between groups for 30-day readmission (14.8% vs 17.6%, P =0.55), ER visits (25.0% vs 28.8%, P =0.49), primary care visits (12.5% vs 8.8%, P =0.34) or unplanned healthcare visits (34.4% vs 35.2%, P =0.89). All patient reported outcomes were significantly improved with median scores higher with the app for satisfaction [9, interquartile range (IQR): 8-10 vs 8, IQR: 7-9, P =0.001], well-being (7, IQR: 6-8 vs 6, IQR: 5-7, P =0.001) and significantly lower for anxiety (3, IQR: 2-5 vs 5, IQR: 3-6, P =0.001). CONCLUSIONS: Although the app did not show a significant reduction in 30-day readmission or ER visits, it did lead to significant improvements in patient-reported outcomes. The app may be an important tool to support patients following colorectal surgery.
Subject(s)
Colorectal Surgery , Mobile Applications , Humans , Patient Readmission , Patient Discharge , AftercareABSTRACT
BACKGROUND: Following IPAA failure, select patients are eligible for IPAA revision. Presently, there is limited evidence describing long-term revision outcomes and predictors of revision failure. This represents an important knowledge gap when selecting and counseling patients. OBJECTIVE: This study aimed to define long-term IPAA survival outcomes after transabdominal IPAA revision and identify preoperative clinical factors associated with revision failure. DESIGN: This was a retrospective cohort study. SETTINGS: This study was conducted at a tertiary referral center. PATIENTS: This study included all patients who underwent revisional IPAA surgery between 1982 and 2017 for pouch failure. INTERVENTION: Transabdominal IPAA revision was included. MAIN OUTCOME MEASURES: The primary outcome was pouch failure, defined as pouch excision or permanent pouch diversion, after IPAA revision. RESULTS: A total of 159 patients (64.2% women) were included with a median age of 36 years (interquartile range, 28.5-46.5) at revision. Eighty percent of patients had a primary diagnosis of ulcerative colitis. The most common indication for revision was leak/pelvic sepsis, representing 41% of the cohort, followed by pouch-vaginal fistula (22.2%), mechanical factors (20.4%), and poor pouch function (14.6%). During the study period, 56 patients (35.2%) experienced pouch failure. The 3-year pouch survival probability was 82.3% (95% CI, 75.5%-87.5%), 5-year pouch survival probability was 77.2% (95% CI, 69.8%-83.0%), and 10-year pouch survival probability was 70.6% (95% CI, 62.6%-77.2%). Compared to mechanical factors, pouch failure was significantly associated with pelvic sepsis (HR, 4.25; 95% CI, 1.50-12.0) and pouch-vaginal fistula (HR, 4.37; 95% CI, 1.47-12.99). No significant association was found between revision failure and previous revision, redo ileoanal anastomosis, or new pouch construction. LIMITATIONS: This study is limited by its retrospective design. CONCLUSIONS: Revisional IPAA can be undertaken with favorable long-term outcomes at high-volume centers. Consideration should be given to indication for revision when counseling patients regarding the risk of failure. Further research on risk stratifying patients before revision is required. See Video Abstract at http://links.lww.com/DCR/B966 . REVISIN DE LA ANASTOMOSIS ANAL DE LA BOLSA ILEAL TRANSABDOMINAL LA INDICACIN DICTA EL RESULTADO: ANTECEDENTES:Después de la falla en la anastomosis del reservorio ileoanal, los pacientes seleccionados son elegibles para la revisión de la anastomosis del reservorio ileoanal. Actualmente, hay evidencias limitadas que describen los resultados de la revisión a largo plazo y los predictores del fracaso de la revisión. Esto representa un importante vacío de investigación a la hora de seleccionar y asesorar a los pacientes.OBJETIVO:Definir los resultados de supervivencia a largo plazo de la IPAA después de la revisión de la anastomosis del reservorio ileoanal transabdominal e identificar los factores clínicos preoperatorios asociados con el fracaso de la revisión.DISEÑO:Este fue un estudio de cohorte retrospectivo.ENTORNO CLINICO:Este estudio se realizó en un centro de referencia terciario.PARTICIPANTES:Todos los pacientes que se sometieron a una cirugía de revisión de la anastomosis ileoanal del reservorio entre 1982 y 2017, por falla del reservorio.INTERVENCIÓN:Revisión de la anastomosis de reservorio ileoanal transabdominal.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario es el fracaso del reservorio, definido como escisión del reservorio o derivación permanente del reservorio, después de la revisión de la anastomosis del reservorio ileoanal.RESULTADOS:Se incluyeron un total de 159 pacientes (64,2% mujeres) con una mediana de edad a la revisión de 36 años (RIC: 28,5-46,5). El ochenta por ciento tenía un diagnóstico primario de colitis ulcerosa. La indicación más común para la revisión fue la fuga/sepsis pélvica, que representó el 41 % de la cohorte, seguida de la fístula vaginal del reservorio (22,2 %), factores mecánicos (20,4 %) y mala función del reservorio 14,6 %. Durante el período de estudio, 56 pacientes (35,2 %) experimentaron fallas en la bolsa. Las probabilidades de supervivencia de la bolsa a los 3, 5 y 10 años fueron del 82,3% (IC del 95%: 75,5%-87,5%), del 77,2% (IC del 95%: 69,8%-83,0%) y del 70,6% (IC del 95%: 62,6%- 77,2%), respectivamente. En comparación con los factores mecánicos, la falla de la bolsa se asoció significativamente con sepsis pélvica (HR = 4,25, IC del 95 %: 1,50 a 12,0) y fístula vaginal de la bolsa (HR = 4,37, IC del 95 %: 1,47 a 12,99). No hubo una asociación significativa entre el fracaso de la revisión y la revisión previa, el rehacer la anastomosis ileoanal o la construcción de una nueva bolsa.LIMITACIONES:El estudio está limitado por su diseño retrospectivo.CONCLUSIONES:La revisión de la anastomosis del reservorio ileoanal se puede realizar con resultados favorables a largo plazo en centros de alto volumen. Se debe considerar la indicación de revisión al asesorar a los pacientes sobre el riesgo de fracaso. Se requiere investigación adicional sobre la estratificación del riesgo de los pacientes antes de la revisión. Consulte Video Resumen en http://links.lww.com/DCR/B966 . (Traducción - Dr. Fidel Ruiz Healy ).
Subject(s)
Colitis, Ulcerative , Fistula , Proctocolectomy, Restorative , Vaginal Fistula , Humans , Female , Adult , Male , Retrospective Studies , Proctocolectomy, Restorative/adverse effects , Colitis, Ulcerative/surgery , Fistula/etiology , Vaginal Fistula/surgery , Postoperative Complications/surgery , Postoperative Complications/etiologyABSTRACT
AIM: Patients undergoing colorectal surgery face high rates of emergency room visits and readmission to hospital. These unplanned hospital visits lead to both increased patient anxiety and health care costs. The aim of this study is to evaluate the use of mobile application to support patients undergoing colorectal surgery following discharge from hospital. METHOD: This study is a randomized controlled trial in which the control group will receive standard follow-up care following discharge after surgery and the intervention group will receive standard follow-up care in addition to the mobile application. The primary outcome is the proportion of patients with unplanned hospital visits within 30 days of discharge. The secondary outcomes are patient-reported outcomes on validated scales evaluating their quality of recovery following discharge. A sample size of 670 subjects is planned. For the primary outcome, the control and intervention groups will be compared using a generalized linear model to account for clustering of patients within centres. For the secondary outcomes, the overall scores on the Quality of Recovery 15 and Patient Activation Measure will be analysed using a linear regression model. RESULTS: It is expected that the results of this study will show that the mobile app will lead to significant improvements in unplanned hospital visits as well as improved quality of recovery for patients. CONCLUSION: If the trial is successful, the mobile app can be easily adopted more widely into clinical practice to support patients at home following surgery.
Subject(s)
Colorectal Surgery , Mobile Applications , Humans , Patient Readmission , Patient Discharge , Aftercare/methods , Randomized Controlled Trials as TopicABSTRACT
Tumor budding (TB) and poorly differentiated clusters (PDCs) are powerful prognostic factors in colorectal cancer (CRC). Despite their morphologic and biological overlap, TB and PDC are assessed separately and are distinguished by an arbitrary cutoff for cell cluster size. This cutoff can be challenging to apply in practice and its biological significance remains unclear. We developed a novel scoring system that incorporates TB and PDC into a single parameter ("Combined Score"; CS), eliminating the need for such cutoffs and allowing the prognostic value of PDC to be captured alongside TB. In a cohort of 481 stage I-III CRC resections, CS was significantly associated with American Joint Committee on Cancer (AJCC) stage, T-stage, N-stage, histologic grade, tumor deposits, lymphovascular invasion, and perineural invasion ( P <0.0001). In addition, CS was significantly associated with decreased 5-year recurrence-free survival, overall survival, and disease-specific survival ( P <0.0001). TB and PDC showed similar associations with oncologic outcomes, with hazard ratios consistently lower than for CS. The association between CS and oncologic outcomes remained significant in subgroup analyses stratified by AJCC stage, anatomic location (rectum/colon) and neoadjuvant therapy status. On multivariable analysis, CS retained its significant association with oncologic outcomes ( P =0.0002, 0.005, and 0.009) for recurrence-free survival, disease-specific survival, and overall survival, respectively. In conclusion, CS provides powerful risk stratification in CRC which is at least equivalent to that of TB and PDC assessed individually. If validated elsewhere, CS has practical advantages and a biological rationale that may make it an attractive alternative to assessing these features separately.
Subject(s)
Colorectal Neoplasms , Neuroblastoma , Colorectal Neoplasms/pathology , Humans , Neoplasm Grading , Neoplasm Staging , Neuroblastoma/pathology , Prognosis , Retrospective StudiesABSTRACT
Surgical management of inflammatory bowel disease has advanced significantly over the years. One particular focus of its evolution has been to minimize invasiveness. Transanal surgery has given the contemporary surgeon an alternate approach to access the low rectum situated in the confines of the deep pelvis. In benign disease, combining transanal surgery with laparoscopy has allowed for the development of novel techniques to create ileal pouch-anal anastomoses, perform intersphincteric Crohn's proctectomies, manage complications from pelvic surgery, and facilitate redo pelvic surgery. We aim to review the indications for transanal surgery in benign disease, describe an approach to transanal pouch surgery in detail, and discuss the potential benefits, pitfalls, and contentious issues surrounding this approach.
Subject(s)
Crohn Disease , Anastomosis, Surgical/adverse effects , Anastomotic Leak/etiology , Anastomotic Leak/prevention & control , Anastomotic Leak/surgery , Cohort Studies , Colon/surgery , Crohn Disease/complications , Crohn Disease/surgery , Humans , Ileum/surgery , Probability , Retrospective Studies , Surgical Stapling/adverse effectsABSTRACT
AIM: Recent evidence has shown no difference in the risk of surgical site infection (SSI) with oral antibiotics alone (OA) and oral antibiotics in combination with mechanical bowel preparation (OA + MBP), suggesting that the use of MBP may be safely avoided. The aim of this work was to determine the absolute risk of SSI that patients would accept with OA relative to OA + MBP. METHOD: Standardized, in-person interviews were conducted using the threshold task with patients attending colorectal surgery clinics who had previously had MBP. Participants were asked which option they preferred when the absolute risk of SSI was 7% for both options. Next, their switch point was determined by increasing the risk of SSI with OA by 1% intervals until their preference changed from OA to OA + MBP. Median switch point scores were reported and represented the absolute increased risk of SSI that patients would accept with OA relative to OA + MBP. RESULTS: Fifty patients completed the interview. All participants chose OA over OA + MBP when the risk of SSI was 7% for both options. Switch points ranged from 8% to 25%, with a median of 10%, indicating that participants were willing to accept up to a 3% increase in absolute risk of developing a SSI with OA to avoid MBP. CONCLUSIONS: The results showed that patients are willing to accept an increased risk of up to 3% for SSI with OA relative to OA + MBP. Incorporating patient preferences into the planning of future trials has the potential to improve the uptake of trial results into clinical practice.
Subject(s)
Colorectal Surgery , Surgical Wound Infection , Administration, Oral , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis/methods , Cathartics/therapeutic use , Colorectal Surgery/adverse effects , Colorectal Surgery/methods , Elective Surgical Procedures/methods , Humans , Preoperative Care/methods , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & controlABSTRACT
Venous invasion (VI) is a powerful yet underreported prognostic factor in colorectal cancer (CRC). Its detection can be improved with an elastin stain. We evaluated the impact of routine elastin staining on VI detection in resected CRC and its relationship with oncologic outcomes. Pathology reports from the year before (n=145) and the year following (n=128) the implementation of routine elastin staining at our institution were reviewed for established prognostic factors, including VI. A second review, using elastin stains, documented the presence/absence, location, number, and size of VI foci. The relationship between VI and oncologic outcomes was evaluated for original and review assessments. VI detection rates increased from 21% to 45% following implementation of routine elastin staining (odds ratio [OR]=3.1; 95% confidence interval [CI]: 1.8-5.3; P<0.0001). The second review revealed a lower VI miss rate postimplementation than preimplementation (22% vs. 48%, respectively; P=0.007); this difference was even greater for extramural VI-positive cases (9% vs. 38%, respectively; P=0.0003). Missed VI cases postimplementation had fewer VI foci per missed case (P=0.02) and a trend towards less extramural VI than those missed preimplementation. VI assessed with an elastin stain was significantly associated with recurrence-free survival (P=0.003), and cancer-specific survival (P=0.01) in contrast to VI assessed on hematoxylin and eosin alone (P=0.053 and 0.1, respectively). The association between VI and hematogenous metastasis was far stronger for elastin-detected VI (OR=11.5; 95% CI: 3.4-37.1; P<0.0001) than for hematoxylin and eosin-detected VI (OR=3.7; 95% CI: 1.4-9.9; P=0.01). Routine elastin staining enhances VI detection and its ability to stratify risk in CRC and should be considered for evaluation of CRC resection specimens.
Subject(s)
Colorectal Neoplasms/chemistry , Elastin/analysis , Veins/chemistry , Adult , Aged , Aged, 80 and over , Azo Compounds , Biomarkers, Tumor , Biopsy , Colectomy , Colorectal Neoplasms/mortality , Colorectal Neoplasms/pathology , Colorectal Neoplasms/surgery , Coloring Agents , Eosine Yellowish-(YS) , Female , Humans , Male , Methyl Green , Middle Aged , Neoplasm Invasiveness , Predictive Value of Tests , Risk Assessment , Risk Factors , Staining and Labeling , Treatment Outcome , Veins/pathology , Young AdultABSTRACT
Melanoma metastases to the groin are frequently managed by therapeutic lymph node dissection. Evidence is lacking regarding the extent of dissection required. Thus, we sought to describe practice patterns for the use of inguinal vs. ilioinguinal dissection, as well as the perioperative/oncologic outcomes of each procedure. A mixed-methods approach was employed to evaluate surgical practice patterns. A retrospective review of three multi-site databases was carried out, together with semi-structured interviews of melanoma surgeons. A total of 347 patients who underwent dissection were reviewed. The main indications stated for adding a "deep" ilioinguinal dissection were palpable or radiologically positive disease. There was no significant difference in complications, length of stay or lymphedema between patients having inguinal vs. ilioinguinal dissection, irrespective of method of diagnosis. There was also no significant difference in recurrence, cancer-specific survival or overall survival between groups. In conclusion, ilioinguinal dissection is a safe and well-tolerated procedure, with no significant added morbidity relative to an inguinal dissection. The indications for ilioinguinal dissection currently in use produce an appropriate deep node positivity rate and ilioinguinal dissection should continue to be used selectively. Randomized data are needed to clarify the impact of ilioinguinal dissection on regional control and survival.
Subject(s)
Melanoma , Skin Neoplasms , Groin/pathology , Groin/surgery , Humans , Lymph Node Excision/methods , Lymphatic Metastasis/pathology , Melanoma/pathology , Melanoma/surgery , Skin Neoplasms/pathology , Skin Neoplasms/surgeryABSTRACT
AIM: In patients with anorectal Crohn's disease, it remains uncertain whether a total proctocolectomy with end ileostomy or proctectomy with end colostomy should be recommended due to the unknown rate of disease recurrence in the remaining colon. METHODS: A retrospective review of all patients with a known diagnosis of Crohn's disease who underwent a proctectomy with end colostomy for distal Crohn's disease between January 1, 2010 and January 1, 2019 at two IBD referral centres was conducted. Data collected included patient demographics, surgical variables at the time of proctectomy, and postoperative clinical, endoscopic and surgical recurrence rates. RESULTS: A total of 63 patients were included; mean age was 47 years (SD 15 years) and 32 (50.8%) were female. The majority of patients underwent a proctectomy with end colostomy (n = 56; 88.9%) while the remaining seven patients (11.1%) underwent a proctectomy with end colostomy and concurrent ileocectomy. A total of 55 patients (87.3%) had proctitis, 51 (81%) had perianal fistulating disease, and 34 (54%) had anal canal stenosis or ulceration. Most patients had medically refractory disease (n = 54; 85.7%) versus neoplasia (n = 9; 14.3%). The median length of long-term follow-up was 17.7 months (IQR: 4.72, 38.7 months). During that time, 14 (22.2%) experienced clinical recurrence, 10 of 34 evaluated (29.4%) had endoscopic recurrence, and 3 (4.76%) required a completion total abdominal colectomy for recurrent medically refractory disease in the colon. CONCLUSION: Colonic recurrence remains low following proctectomy and descending colostomy suggesting this operative management strategy is reasonable in Crohn's patients with distal disease.
Subject(s)
Colonic Diseases , Crohn Disease , Neoplasms , Proctocolectomy, Restorative , Colostomy , Crohn Disease/surgery , Female , Humans , Ileostomy , Middle Aged , Recurrence , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND AND AIMS: Following subtotal colectomy or diversion for medically refractory inflammatory bowel disease [IBD], completion proctectomy has been recommended to reduce the risk of rectal cancer. However, this recommendation is based on low-quality evidence. Our objectives were to estimate the cumulative incidence of rectal cancer and evaluate if surveillance endoscopy reduces the risk of rectal cancer. METHODS: We performed a population-based retrospective cohort study in Ontario, Canada, of all patients undergoing either subtotal colectomy or diversion for medically refractory IBD over 1991-2015. We excluded patients with a previous history of colorectal cancer or previous rectal resection, and those with <1 year of observation. We calculated the rate of incident rectal cancer using a competing risks model, and evaluated the effect of surveillance endoscopy on the rate of rectal cancer. RESULTS: In all, 3700 patients were included with a median follow-up of 4.3 years. Of this cohort, 47% underwent rectal resection or restoration of gastrointestinal [GI] continuity during the observation period; 40 patients were diagnosed with rectal cancer, with a cumulative incidence of rectal cancer of 0.81% (95% confidence interval [CI] 0.53%, 1.20%) and 1.86% [95% CI 1.29%, 2.61%] at 10 and 20 years, respectively. Surveillance endoscopy was associated with a lower rate of rectal cancer (subhazard ratio [sHR] 0.37, 95% CI 0.16, 0.82, p = 0.014]. CONCLUSIONS: Among patients with a retained rectum following surgery for IBD, the risk of rectal cancer is low and appears to be lower when surveillance endoscopy is performed. Expectant management with surveillance endoscopy may be a reasonable alternative to completion proctectomy in selected patients.
Subject(s)
Colectomy/standards , Irritable Bowel Syndrome/surgery , Rectal Neoplasms/diagnosis , Adult , Cohort Studies , Colectomy/methods , Colectomy/statistics & numerical data , Female , Humans , Incidence , Irritable Bowel Syndrome/complications , Irritable Bowel Syndrome/epidemiology , Male , Middle Aged , Ontario , Rectal Neoplasms/epidemiology , Retrospective StudiesABSTRACT
BACKGROUND: Functional outcomes after ileoanal pouch creation have been studied; however, there is great variability in how relevant outcomes are defined and reported. More importantly, the perspective of patients has not been represented in deciding which outcomes should be the focus of research. OBJECTIVE: The primary aim was to create a patient-centered definition of core symptoms that should be included in future studies of pouch function. DESIGN: This was a Delphi consensus study. SETTING: Three rounds of surveys were used to select high-priority items. Survey voting was followed by a series of online patient consultation meetings used to clarify voting trends. A final online consensus meeting with representation from all 3 expert panels was held to finalize a consensus statement. PATIENTS: Expert stakeholders were chosen to correlate with the clinical scenario of the multidisciplinary team that cares for pouch patients, including patients, colorectal surgeons, and gastroenterologists or other clinicians. MAIN OUTCOME MEASURES: A consensus statement was the main outcome. RESULTS: patients, 62 colorectal surgeons, and 48 gastroenterologists or nurse specialists completed all 3 Delphi rounds. Fifty-three patients participated in online focus groups. One hundred sixty-one stakeholders participated in the final consensus meeting. On conclusion of the consensus meeting, 7 bowel symptoms and 7 consequences of undergoing ileoanal pouch surgery were included in the final consensus statement. LIMITATIONS: The study was limited by online recruitment bias. CONCLUSIONS: This study is the first to identify key functional outcomes after pouch surgery with direct input from a large panel of ileoanal pouch patients. The inclusion of patients in all stages of the consensus process allowed for a true patient-centered approach in defining the core domains that should be focused on in future studies of pouch function. See Video Abstract at http://links.lww.com/DCR/B571. LOS PACIENTES SOMETIDOS A CIRUGA DE RESERVORIO ILEOANAL EXPERIMENTAN UNA CONSTELACIN DE SNTOMAS Y CONSECUENCIAS QUE REPRESENTAN UN SNDROME UNICO: Un Informe de los Resultados Reportados por los Pacientes Posterior a la Cirugía de Reservorio (PROPS) Estudio de Consenso DelphiANTECEDENTES:Los resultados funcionales después de la creación del reservorio ileoanal han sido estudiados; sin embargo, existe una gran variabilidad en la forma en que se definen y reportan los resultados relevantes. Más importante aún, la perspectiva de los pacientes no se ha representado a la hora de decidir qué resultados deberían ser el foco de investigación.OBJETIVO:El objetivo principal era crear en el paciente una definición centrada de los síntomas principales que debería incluirse en los estudios futuros de la función del reservorio.DISEÑO:Estudio de consenso Delphi.ENTORNO CLINICO:Se emplearon tres rondas de encuestas para seleccionar elementos de alta prioridad. La votación de la encuesta fue seguida por una serie de reuniones de consulta de pacientes en línea que se utilizan para aclarar las tendencias de votación. Se realizo una reunión de consenso final en línea con representación de los tres paneles de expertos para finalizar una declaración de consenso.PACIENTES:Se eligieron partes interesadas expertas para correlacionar con el escenario clínico del equipo multidisciplinario que atiende a los pacientes con reservorio: pacientes, cirujanos colorrectales, gastroenterólogos / otros médicos.PRINCIPALES MEDIDAS DE VALORACION:Declaración de consenso.RESULTADOS:Ciento noventa y cinco pacientes, 62 cirujanos colorrectales y 48 gastroenterólogos / enfermeras especialistas completaron las tres rondas Delphi. 53 pacientes participaron en grupos focales en línea. 161 interesados participaron en la reunión de consenso final. Al concluir la reunión de consenso, siete síntomas intestinales y siete consecuencias de someterse a una cirugía de reservorio ileoanal se incluyeron en la declaración de consenso final.LIMITACIONES:Sesgo de reclutamiento en línea.CONCLUSIONES:Este estudio es el primero en identificar resultados funcionales claves después de la cirugía de reservorio con información directa de un gran panel de pacientes con reservorio ileoanal. La inclusión de pacientes en todas las etapas del proceso de consenso permitió un verdadero enfoque centrado en el paciente para definir los dominios principales en los que debería centrarse los estudios futuros de la función del reservorio. Consulte Video Resumen en http://links.lww.com/DCR/B571.
Subject(s)
Colitis, Ulcerative/surgery , Colonic Pouches/adverse effects , Consensus , Proctocolectomy, Restorative/adverse effects , Stakeholder Participation/psychology , Adult , Colonic Pouches/physiology , Defecation/physiology , Delphi Technique , Fecal Incontinence/epidemiology , Fecal Incontinence/psychology , Focus Groups/methods , Gastroenterologists/statistics & numerical data , Humans , Inflammatory Bowel Diseases/surgery , Interdisciplinary Communication , Middle Aged , Outcome Assessment, Health Care , Patient Reported Outcome Measures , Postoperative Complications/epidemiology , Proctocolectomy, Restorative/methods , Surgeons/statistics & numerical data , Surveys and Questionnaires , Symptom Assessment/methods , Symptom Assessment/psychology , SyndromeABSTRACT
OBJECTIVE: The primary aim was to create a patient-centered definition of core symptoms that should be included in future studies of pouch function. BACKGROUND: Functional outcomes after ileoanal pouch creation have been studied; however, there is great variability in how relevant outcomes are defined and reported. More importantly, the perspective of patients has not been represented in deciding which outcomes should be the focus of research. METHODS: Expert stakeholders were chosen to correlate with the clinical scenario of the multidisciplinary team that cares for pouch patients: patients, colorectal surgeons, gastroenterologists/other clinicians. Three rounds of surveys were employed to select high-priority items. Survey voting was followed by a series of online patient consultation meetings used to clarify voting trends. A final online consensus meeting with representation from all 3 expert panels was held to finalize a consensus statement. RESULTS: One hundred ninety-five patients, 62 colorectal surgeons, and 48 gastroenterologists/nurse specialists completed all 3 Delphi rounds. Fifty-three patients participated in online focus groups. One hundred sixty-one stakeholders participated in the final consensus meeting. On conclusion of the consensus meeting, 7 bowel symptoms and 7 consequences of undergoing ileoanal pouch surgery were included in the final consensus statement. CONCLUSIONS: This study is the first to identify key functional outcomes after pouch surgery with direct input from a large panel of ileoanal pouch patients. The inclusion of patients in all stages of the consensus process allowed for a true patient-centered approach in defining the core domains that should be focused on in future studies of pouch function.