RESUMEN
BACKGROUND: The ligation of intersphincteric fistula tract is a surgical technique designed to treat trans-sphincteric anal fistulas aiming to preserve sphincter integrity. Recent studies suggest its efficacy in short-term fistula healing with limited impact on continence. However, comprehensive prospective data on long-term outcomes, including recurrence and bowel continence, are limited. The present study aims to report on the long-term functional outcomes. METHODS: Patients who underwent the ligation of intersphincteric fistula tract procedure for trans-sphincteric cryptoglandular anal fistulas between July 2012 and October 2018 at two Dutch referral centres were retrospectively reviewed. The primary outcome of interest was the long-term bowel continence after the ligation of intersphincteric fistula tract procedure, using the faecal incontinence severity index. Short-term data (collected in 2018) and long-term data (collected in 2023) on bowel continence, healing rates and recurrences were obtained through electronic records and Rockwood questionnaires. Sankey diagrams were used to visually represent individual variations in continence status (preoperative versus follow-up). RESULTS: Among 110 patients included (50% female, median follow-up 92 months), 101 patients (92%) were treated with previous surgeries (median 2, range 0-6) and 80% had previous seton drainage. Preligation of intersphincteric fistula tract, 16% of the patients reported incontinence (mean(s.d.) faecal incontinence severity index: 2.4(7.5), increasing to 18% after ligation of intersphincteric fistula tract at short-term follow-up, including 11% newly induced cases. Long-term follow-up collected using Rockwood questionnaires (63% response rate) in 69 patients uncovered a 74% incontinency rate (mean(s.d.) faecal incontinence severity index: 9.22(9.5). In those patients without subsequent surgery 49% (17 of 35) reported incontinence at long-term follow-up. Primary fistula healing after ligation of intersphincteric fistula tract was 28%. Preoperative seton drainage significantly improved healing rates (33% versus 9%). Notably, 43% (34 of 79) of unhealed fistulas transitioned into intersphincteric tracts; in these patients, 19 were treated with subsequent fistulotomy achieving cure in 18 cases. CONCLUSIONS: Ligation of intersphincteric fistula tract healing rates fell below recent literature standards. Although the immediate impact on postoperative continence appears minimal, long-term incontinence rates are concerning. In recognizing the deterioration of individual continence, we advocate for a patient-centered approach and urge fellow researchers and clinicians to collect comprehensive prospective continence data.
Asunto(s)
Canal Anal , Incontinencia Fecal , Fístula Rectal , Humanos , Fístula Rectal/cirugía , Femenino , Masculino , Ligadura/métodos , Incontinencia Fecal/etiología , Incontinencia Fecal/cirugía , Persona de Mediana Edad , Estudios Retrospectivos , Canal Anal/cirugía , Adulto , Resultado del Tratamiento , Recurrencia , AncianoRESUMEN
AIM: Most new ostomy patients are not able to manage ostomy self-care when they are discharged and rely on visiting nurse services for ostomy care. The aim of this study was to determine if a perioperative ostomy educational pathway increases the level of independence and decreases the need for visiting nurse services in new ostomy patients. METHOD: A prospective longitudinal study was conducted between July 2018 and February 2020. Patients who received a colostomy or ileostomy and were treated on the surgery ward were included. Patients who followed a perioperative ostomy educational pathway were compared to a historical control group. The primary outcome measure was the level of independence in ostomy care and the need for visiting nurse services. RESULTS: After discharge, 67.6% of patients in the intervention group (n = 244) were able to independently perform ostomy care and were therefore not relying on visiting nurse services, compared to 15.2% of the patients in the control group (n = 33). The need for visiting nurse services was higher in patients aged ≥70 years (OR 3.20, P < 0.001), those who did not attend the preoperative practice session (OR 3.02, P = 0.002), those with a history of transient ischaemic attack (OR 10.22, P = 0.045) and those with mild cognitive impairment (OR 28.98, P = 0.002). CONCLUSION: A perioperative ostomy educational pathway effectively increased the level of independence and decreased the need for visiting nurse services in new ostomy patients.
Asunto(s)
Ileostomía , Educación del Paciente como Asunto , Autocuidado , Humanos , Femenino , Masculino , Anciano , Estudios Prospectivos , Estudios Longitudinales , Persona de Mediana Edad , Ileostomía/enfermería , Educación del Paciente como Asunto/métodos , Colostomía/enfermería , Enfermería en Salud Comunitaria , Atención Perioperativa/métodos , Anciano de 80 o más Años , Alta del Paciente , Estomía/enfermeríaRESUMEN
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Whether adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) might prevent peritoneal metastases after curative surgery for high-risk colon cancer is an ongoing debate. This study aimed to determine 5-year oncologic outcomes of the randomized multicenter COLOPEC trial, which included patients with clinical or pathologic T4N0-2M0 or perforated colon cancer and randomly assigned (1:1) to either adjuvant systemic chemotherapy and HIPEC (n = 100) or adjuvant systemic chemotherapy alone (n = 102). HIPEC was performed using a one-time administration of oxaliplatin (460 mg/m2, 30 minutes, 42°C, concurrent fluorouracil/leucovorin intravenously), either simultaneously (9%) or within 5-8 weeks (91%) after primary tumor resection. Outcomes were analyzed according to the intention-to-treat principle. Long-term data were available of all 202 patients included in the COLOPEC trial, with a median follow-up of 59 months (IQR, 54.5-64.5). No significant difference was found in 5-year overall survival rate between patients assigned to adjuvant HIPEC followed by systemic chemotherapy or only adjuvant systemic chemotherapy (69.6% v 70.9%, log-rank; P = .692). Five-year peritoneal metastases rates were 63.9% and 63.2% (P = .907) and 5-year disease-free survival was 55.7% and 52.3% (log-rank; P = .875), respectively. No differences in quality-of-life outcomes were found. Our findings implicate that adjuvant HIPEC should still be performed in trial setting only.
Asunto(s)
Neoplasias del Colon , Neoplasias Colorrectales , Hipertermia Inducida , Neoplasias Peritoneales , Humanos , Quimioterapia Intraperitoneal Hipertérmica , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Peritoneales/tratamiento farmacológico , Neoplasias Peritoneales/secundario , Hipertermia Inducida/métodos , Neoplasias del Colon/tratamiento farmacológico , Neoplasias del Colon/patología , Quimioterapia Adyuvante/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Terapia Combinada , Procedimientos Quirúrgicos de CitorreducciónRESUMEN
Importance: Neoadjuvant short-course radiotherapy was routinely applied for nonlocally advanced rectal cancer (cT1-3N0-1M0 with >1 mm distance to the mesorectal fascia) in the Netherlands following the Dutch total mesorectal excision trial. This policy has shifted toward selective application after guideline revision in 2014. Objective: To determine the association of decreased use of neoadjuvant radiotherapy with cancer-related outcomes and overall survival at a national level. Design, Setting, and Participants: This multicenter, population-based, nationwide cross-sectional cohort study analyzed Dutch patients with rectal cancer who were treated in 2011 with a 4-year follow-up. A similar study was performed in 2021, analyzing all patients that were surgically treated in 2016. From these cohorts, all patients with cT1-3N0-1M0 rectal cancer and radiologically unthreatened mesorectal fascia were included in the current study. The data of the 2011 cohort were collected between May and October 2015, and the data of the 2016 cohort were collected between October 2020 and November 2021. The data were analyzed between May and October 2022. Main Outcomes and Measures: The main outcomes were 4-year local recurrence and overall survival rates. Results: Among the 2011 and 2016 cohorts, 1199 (mean [SD] age, 68 [11] years; 430 women [36%]) of 2095 patients (57.2%) and 1576 (mean [SD] age, 68 [10] years; 547 women [35%]) of 3057 patients (51.6%) had cT1-3N0-1M0 rectal cancer and were included, with proportions of neoadjuvant radiotherapy of 87% (2011) and 37% (2016). Four-year local recurrence rates were 5.8% and 5.5%, respectively (P = .99). Compared with the 2011 cohort, 4-year overall survival was significantly higher in the 2016 cohort (79.6% vs 86.4%; P < .001), with lower non-cancer-related mortality (13.8% vs 6.3%; P < .001). Conclusions and Relevance: The results of this cross-sectional study suggest that an absolute 50% reduction in radiotherapy use for nonlocally advanced rectal cancer did not compromise cancer-related outcomes at a national level. Optimizing clinical staging and surgery following the Dutch total mesorectal excision trial has potentially enabled safe deintensification of treatment.
Asunto(s)
Terapia Neoadyuvante , Neoplasias del Recto , Humanos , Femenino , Anciano , Estudios Transversales , Neoplasias del Recto/patología , Países Bajos/epidemiología , Estadificación de Neoplasias , Recurrencia Local de Neoplasia/cirugíaRESUMEN
BACKGROUND: It is often stated that loose seton drainage results in distal migration of a fistula tract in perianal fistula. The aim of the present study was to assess this distalization of trans- and suprasphincteric perianal fistulas after a silicone seton has been inserted. METHODS: Consecutive patients who underwent loose seton placement for the management of a transsphincteric or suprasphincteric fistula between January 2016 and December 2021 with a pre- and postoperative magnetic resonance imaging (MRI) were included in the present retrospective study. The height of the external anal sphincter (EAS) and the level of penetration of perianal fistula through the EAS or puborectal muscle (PRM) were determined on MRI. Primary outcome was migration of the fistula tract through the EAS and PRM. RESULTS: Thirty-eight patients with perianal fistulas were included. Median height of the EAS was 28 (IQR 25-34) mm before seton placement and 27 (IQR 24-33) mm afterward. Median level of perforation was 32 (IQR 17-40) mm before seton placement and 28 (IQR 17-40) mm afterward (p = 0.37). One fistula (3%) was downgraded from mid to low transsphincteric and was laid open after 14.9 months of loose seton drainage. CONCLUSIONS: No statistically significant distalization of complex fistula tracts after loose silicone seton drainage was found. Some complex fistulas may downgrade to a less complex fistula after long-term seton drainage. However, loose silicone seton drainage should not be offered to patients as a treatment option to downgrade a complex fistula to a simple one or even have the hope to heal it.
Asunto(s)
Fístula Rectal , Humanos , Estudios Retrospectivos , Fístula Rectal/etiología , Fístula Rectal/cirugía , Canal Anal/cirugía , Drenaje/métodos , Inflamación , Resultado del TratamientoRESUMEN
BACKGROUND: Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level. METHODS: Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (≥7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those undergoing only rectal resection. RESULTS: Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874). CONCLUSION: Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research.
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Escisión del Ganglio Linfático , Neoplasias del Recto , Humanos , Escisión del Ganglio Linfático/métodos , Estudios Transversales , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patología , Neoplasias del Recto/patología , Recto/patología , Estudios Retrospectivos , Recurrencia Local de Neoplasia/cirugía , Recurrencia Local de Neoplasia/patología , Estadificación de NeoplasiasRESUMEN
BACKGROUND: Primary anastomosis (PA) in left-sided colorectal cancer (CRC) surgery in elderly patients is disputed. The aim of our study was to evaluate the differences in postoperative outcomes after left-sided CRC surgery in elderly patients in The Netherlands, comparing patients with PA and those who underwent end-ostomy (EO). METHOD: Patients aged ≥ 75 years with stage I-III left-sided CRC, diagnosed and surgically treated in 2015-2017 were selected from the Netherlands Cancer Registry (n = 3286). Postoperative outcomes, short-term (30-, 60-, and 90-day) mortality and 3-year overall and relative survival were analyzed, stratified by surgical resection with PA versus EO. Propensity score matching (PSM) and multivariable logistic regression analysis were conducted. RESULTS: Patients with higher age, higher American Society of Anesthesiologists classification and higher tumor stage, a perforation, ileus or tumor located in the proximal rectum, and after open or converted surgery were more likely to receive EO. No difference in anastomotic leakage was seen in PA patients with or without defunctioning stoma (6.2% vs. 7.0%, p = 0.680). Postoperative hospital stay was longer (7.0 vs. 6.0 days, p < 0.0001) and more often prolonged (19% vs. 13%, p = 0.03) in EO patients. Sixty-day mortality (2.9% vs. 6.4%, p < 0.0001), 90-day mortality (3.4% vs. 7.7%, p < 0.0001), and crude 3-year survival (81.2% vs. 58.7%, p < 0.0001) were significantly higher in EO patients, remaining significant after multivariable and PSM analysis. CONCLUSION: There are significant differences between elderly patients after left-sided CRC surgery with PA versus EO in terms of postoperative length of stay, short-term survival, 3-year overall survival, and relative survival at disadvantage of EO patients. This information could be important for decision making regarding surgical treatment in the elderly.
Asunto(s)
Estomía , Neoplasias del Recto , Anciano , Anastomosis Quirúrgica , Humanos , Puntaje de Propensión , Neoplasias del Recto/cirugía , Recto , Resultado del TratamientoRESUMEN
BACKGROUND: There is wide variation in gender distribution in colorectal surgery across different European countries. OBJECTIVE: This study aimed to evaluate female representation, implicit bias, and members' perception on female participation and representation at the European Society of Coloproctology 2017 annual scientific meeting. DESIGN: This was a retrospective mixed-methods cross-sectional observational study. SETTINGS: The study was conducted using data from the 2017 European Society of Coloproctology annual scientific meeting program and attendees. MAIN OUTCOME MEASURES: The primary outcome measure was the percentage of female speakers in the formal program and assessment for implicit bias. Secondary outcomes were the percentage of women attending the conference, the percentage of women serving on committees, and the results of the online survey. METHODS: Female representation was retrospectively quantified by role, session type, and topic. Implicit bias was measured classifying the introductions of speakers by moderators as formal (using a professional title) or informal (using name only), then further stratified by gender. An online survey was disseminated and analyzed to investigate the members' perception as a benchmark analysis. RESULTS: Disparities were found between sexes, with fewer women attending the conference (25%), serving as session chairs (8%), speakers (21%), and on committees (10%) compared with men. There were no differences across sexes regarding the formal or informal introduction. The survey among our members showed that significantly fewer women felt equally endorsed within the society compared with men (33% versus 63%; p < 0.001). LIMITATIONS: The retrospective design with data available to be analyzed was limited by the sessions recorded (27/49) and survey respondents (28%). CONCLUSIONS: Female representation within European Society of Coloproctology as chair, speaker, attendee, and committee member was much lower than male representation, both in absolute numbers and relative to membership. Greater awareness of this disparity and inclusiveness are aims of our society. The impact of these initiatives will be determined by reevaluating these metrics at the 2020 annual meeting. See Video Abstract at http://links.lww.com/DCR/B384. REPRESENTACIN Y POSICIN FEMENINA EN LA SOCIEDAD EUROPEA DE COLOPROCTOLOGA BASADA EN LOS HECHOS Y LAS OPINIONES DE SUS MIEMBROS: ANTECEDENTES:Existe una amplia variabilidad en la distribución de géneros en la cirugía colorrectal en los diferentes países de Europa.OBJETIVO:Evaluar la representación femenina, el sesgo implícito y la percepción de los miembros sobre la participación y representación femenina en el 12° Congreso científico anual de la Sociedad Europea de Coloproctología.DESIGN:Este fué un estudio observacional retrospectivo de métodos mixtos transversales.AJUSTES:Los análisis se realizaron utilizando los datos del programa cintífico de la reunión y los datos de los presentes en el Congreso de la ESCP en 2017.MEDIDAS PRINCIPALES DE RESULTADOS:La principal medida en el resultado fue el porcentaje de disertantes femeninas en el programa definitivo y la evaluación del sesgo implícito. Los resultados secundarios fueron el porcentaje de mujeres que asistieron a la conferencia, trabajaron en los comités y los resultados de la encuesta informática.METODOS:La representación femenina se cuantificó retrospectivamente según el rol, tipo de sesión y temas. Se midió el sesgo implícito clasificando las introducciones de los disertantes por parte de los moderadores de manera formal (usando un título profesional) o informal (usando solamente el nombre), y luego fueron estratificadas por género. Se difundió y analizó una encuesta informática para investigar la percepción de los miembros como análisis de referencia.RESULTADOS:Se encontraron disparidades de género, con menos mujeres presentes en la conferencia (25%), obrando como presidentes de sesión (8%), como disertantes (21%) y como miembros de comités (10%) comparadas con los hombres. No hubo diferencia entre sexos con respecto a la introducción formal o informal. La encuesta informática entre los miembros mostró significativamente que menos mujeres se sentían respaldadas igualitariamente dentro de la sociedad comparadas con los hombres (33% frente a 63%, p<0.001).LIMITACIONES:Diseño retrospectivo de datos limitados a las sesiones grabadas (27/49) y a los encuestados (28%) disponibles para el análisis.CONCLUSIONES:La representación femenina dentro de la Sociedad Europea de Coloproctología como presidente, disertante, asistente ó como miembro del comité fué mucho menor que la representación masculina, tanto en números absolutos como en relación con la membresía. Crear una mayor conciencia de esta disparidad de inclusión son prioridad en nuestra sociedad. El impacto de estas iniciativas se determinará re-evaluando estas variables en reuniones futuras. Consulte Video Resumen en http://links.lww.com/DCR/B384.
Asunto(s)
Cirugía Colorrectal/ética , Prejuicio/ética , Sexismo/estadística & datos numéricos , Sociedades Médicas/ética , Encuestas y Cuestionarios/estadística & datos numéricos , Adulto , Concienciación , Cirugía Colorrectal/organización & administración , Congresos como Asunto/estadística & datos numéricos , Estudios Transversales , Europa (Continente) , Femenino , Equidad de Género , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Distribución por Sexo , Percepción Social/ética , Sociedades Médicas/organización & administración , Compromiso LaboralRESUMEN
BACKGROUND: The ileostomy pathway, introduced in 2011, has proved to be successful in eliminating hospital readmissions for high-output ileostomy or dehydration in the following period of 7 months in a single institution. However, it is unclear whether this short-term success, immediately after the initiation of the program, can be sustainable in the long term. OBJECTIVE: The aim of this study was to assess the efficacy and the durability of the ileostomy pathway in reducing readmissions for dehydration over a longer period of time. DESIGN: This was a retrospective review of the patients who entered into the ileostomy pathway, since its introduction on March 1, 2011, until January 31, 2015. SETTINGS: This study was conducted at a tertiary academic center. PATIENTS: Patients undergoing colorectal surgery with the creation of a new end or loop ileostomy were included. INTERVENTION: The long-term sustainability of the ileostomy pathway was assessed. MAIN OUTCOME MEASURES: The primary end point was readmission within 30 days after discharge for a high-output ileostomy or dehydration. RESULTS: A total of 393 patients (male n = 195, female n = 198, median age 52 (18-87) years) were included: 161 prepathway and 232 on-pathway. Overall 30-day postdischarge readmission rates decreased from 35.4% to 25.9% (p = 0.04). Readmissions due to high output and/or dehydration dropped from 15.5% to 3.9% (p < 0.001). Readmissions due to small-bowel obstructions dropped from 9.9% to 4.3%, (p = 0.03). LIMITATIONS: The possible limitations of the study included a nonrandomized comparison of the patient groups and those patients who were possibly admitted to different institutions. CONCLUSIONS: The present ileostomy pathway decreases readmissions for high-output ileostomy and dehydration in patients with new ileostomies and is durable in the long term. See Video Abstract at http://links.lww.com/DCR/B233. EFICACIA DE VÍA DE ILEOSTOMÍA PARA REDUCIR LOS REINGRESOS POR DESHIDRATACIÓN: ¿RESISTE LA PRUEBA DEL TIEMPO?: La vía de ileostomía, introducida en 2011, ha demostrado ser exitosa en la eliminación de reingresos hospitalarios por ileostomía de alto rendimiento o deshidratación, por un período de 7 meses, en una sola institución. Sin embargo, no se ha aclarado si el éxito es a corto plazo, inmediatamente después del inicio del programa, y de que pueda ser sostenible a largo plazo.El objetivo de este estudio fue evaluar la eficacia y la durabilidad de la vía de ileostomía, para disminuir los reingresos por deshidratación, durante un período de tiempo más largo.Esta fue una revisión retrospectiva de pacientes que ingresaron a la vía de ileostomía, desde su introducción el 1 de marzo de 2011 hasta el 31 de enero de 2015.Este estudio se realizó en un centro académico terciario.Se incluyeron pacientes sometidos a cirugía colorrectal con la creación de una nueva ileostomía de extremo o asa.Evaluar la sostenibilidad de la vía de ileostomía a largo plazo.El punto final primario fue el reingreso dentro de los 30 días posteriores al alta, por una ileostomía de alto gasto o deshidratación.Se incluyeron un total de 393 pacientes (hombres n = 195, mujeres n = 198, edad media 52 [18-87] años), 161 antes de la vía y 232 en la vía. En general, las tasas de reingreso después del alta a 30 días, disminuyeron de 35.4% a 25.9% (p = 0.04). Los reingresos por alto rendimiento y / o deshidratación, disminuyeron del 15.5% al 3.9% (p < 0.001). Los reingresos debidos a obstrucciones del intestino delgado, disminuyeron del 9.9% al 4.3% (p = 0.03).Las posibles limitaciones del estudio incluyeron una comparación no aleatoria de los grupos de pacientes, y de aquellos pacientes que posiblemente fueron admitidos en diferentes instituciones.La vía de ileostomía disminuye los reingresos por ileostomía de alto gasto y deshidratación, en nuevos pacientes con ileostomía, y es duradera a largo plazo. Consulte Video Resumen en http://links.lww.com/DCR/B233.
Asunto(s)
Cirugía Colorrectal/métodos , Deshidratación/prevención & control , Ileostomía/efectos adversos , Readmisión del Paciente/estadística & datos numéricos , Adulto , Anciano , Estudios de Casos y Controles , Cirugía Colorrectal/tendencias , Femenino , Humanos , Obstrucción Intestinal/epidemiología , Masculino , Persona de Mediana Edad , Alta del Paciente/tendencias , Complicaciones Posoperatorias/epidemiología , Evaluación de Programas y Proyectos de Salud , Estudios Retrospectivos , Automanejo , Factores de TiempoRESUMEN
BACKGROUND: In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden. METHODS: Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior. DISCUSSION: This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future. TRIAL REGISTRATION: Netherlands Trial Register, NL7083 , 06 July 2018.
Asunto(s)
Neoplasias Colorrectales , Resección Endoscópica de la Mucosa , Neoplasias del Recto , Cirugía Endoscópica Transanal , Resección Endoscópica de la Mucosa/efectos adversos , Europa (Continente) , Humanos , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia , Países Bajos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias del Recto/cirugía , Cirugía Endoscópica Transanal/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND AND AIMS: Most patients with perianal Crohn's fistula receive medical treatment with anti-tumour necrosis factor [TNF], but the results of anti-TNF treatment have not been directly compared with chronic seton drainage or surgical closure. The aim of this study was to assess if chronic seton drainage for patients with perianal Crohn's disease fistulas would result in less re-interventions, compared with anti-TNF and compared with surgical closure. METHODS: This randomised trial was performed in 19 European centres. Patients with high perianal Crohn's fistulas with a single internal opening were randomly assigned to: i] chronic seton drainage for 1 year; ii] anti-TNF therapy for 1 year; and iii] surgical closure after 2 months under a short course anti-TNF. The primary outcome was the cumulative number of patients with fistula-related re-intervention[s] at 1.5 years. Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort. RESULTS: Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate [10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, pâ =â 0.02]. No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry, inferiority of chronic seton treatment was not observed for any outcome measure. CONCLUSIONS: The results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn's fistulas.
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Adalimumab , Enfermedad de Crohn/complicaciones , Drenaje , Infliximab , Calidad de Vida , Fístula Rectal , Técnicas de Cierre de Heridas , Adalimumab/administración & dosificación , Adalimumab/efectos adversos , Adulto , Terapia Combinada , Drenaje/efectos adversos , Drenaje/métodos , Drenaje/estadística & datos numéricos , Terminación Anticipada de los Ensayos Clínicos , Femenino , Humanos , Infliximab/administración & dosificación , Infliximab/efectos adversos , Masculino , Inutilidad Médica , Evaluación de Procesos y Resultados en Atención de Salud , Gravedad del Paciente , Fístula Rectal/etiología , Fístula Rectal/psicología , Fístula Rectal/terapia , Reoperación/métodos , Reoperación/estadística & datos numéricos , Inhibidores del Factor de Necrosis Tumoral/administración & dosificación , Inhibidores del Factor de Necrosis Tumoral/efectos adversos , Técnicas de Cierre de Heridas/efectos adversos , Técnicas de Cierre de Heridas/estadística & datos numéricosRESUMEN
BACKGROUND: Considerable morbidity (10-14%) and even mortality (4-30%) have been reported after reversal of intestinal continuity following Hartmann's procedure. Feasibility of and advantages in reducing peri- and postoperative morbidity by utilizing single-port techniques through the colostomy site have been suggested before in small case series. The purpose of the present prospective observational study is to evaluate the outcomes of reversal of intestinal continuity using single-port access in a relatively large consecutive cohort. METHODS: All consecutive patients undergoing single-port reversal of left-sided colostomy (SPRLC) between November 2012 and 2018 were included in the present study. Primary outcome was 30-day postoperative complication rate. Secondary outcomes were postoperative length of stay, single-port success rate, and surgical details like duration and conversion rates. RESULTS: Of 85 procedures, 69.4% were without postoperative complications. No postoperative mortality was encountered. Superficial site infection is the most frequent complication and occurred in 22.4%, major complications classified as Clavien-Dindo grade 3 or above in 9.4% and anastomotic leakage in 3.5%. Median length of stay was 3.0 days (1-69), single-port success rate was 64.7%, and 15.3% was converted to an open procedure. CONCLUSION: This study confirms the safety, feasibility, and the advantages of SPRLC. In centers with adequate laparoscopic experienced surgeons, this technique should be considered as a serious and attractive alternative to restore intestinal continuity in patients with left-sided end colostomy, especially in patients after open index surgery. More research must be done in a multicenter setting to evaluate the use and standardization of single-port technique in reversal of intestinal continuity procedures.
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Colon/cirugía , Colostomía , Laparoscopía/métodos , Adulto , Anciano , Anciano de 80 o más Años , Anastomosis Quirúrgica/métodos , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Complicaciones Posoperatorias/epidemiología , Estudios ProspectivosRESUMEN
BACKGROUND: Nearly a quarter of patients with locally advanced (T4 stage) or perforated colon cancer are at risk of developing peritoneal metastases, often without curative treatment options. We aimed to determine the efficacy of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced colon cancer. METHODS: This multicentre, open-label trial was done in nine hospitals that specialised in HIPEC in the Netherlands. Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer were randomly assigned (1:1), with a web-based randomisation application, before resection of the primary tumour, to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group). Patients were stratified by tumour characteristic (T4 or perforation), age (<65 years or ≥65 years), and surgical approach of the primary tumour resection (laparoscopic or open). Key eligibility criteria included age between 18 and 75 years, adequate clinical condition for HIPEC, and intention to start adjuvant systemic chemotherapy. Patients with metastatic disease were ineligible. Adjuvant HIPEC consisted of fluorouracil (400 mg/m2) and leucovorin (20 mg/m2) delivered intravenously followed by intraperitoneal delivery of oxaliplatin (460 mg/m2) for 30 min at 42°C, delivered simultaneously or within 5-8 weeks after primary tumour resection. In all patients without evidence of recurrent disease at 18 months, a diagnostic laparoscopy was done. The primary endpoint was peritoneal metastasis free-survival at 18 months, measured in the intention-to-treat population, with the Kaplan-Meier method. Adverse events were assessed in all patients who received assigned treatment. This study is registered with ClinicalTrials.gov, number NCT02231086. FINDINGS: Between April 1, 2015, and Feb 20, 2017, 204 patients were randomly assigned to treatment (102 in each group). In the HIPEC group, two patients withdrew consent after randomisation. In this group, 19 (19%) of 100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months. In the control group, 23 (23%) of 102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy). In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28). 12 (14%) of 87 patients who received adjuvant HIPEC developed postoperative complications and one (1%) encapsulating peritoneal sclerosis. INTERPRETATION: In patients with T4 or perforated colon cancer, treatment with adjuvant HIPEC with oxaliplatin did not improve peritoneal metastasis-free survival at 18 months. Routine use of adjuvant HIPEC is not advocated on the basis of this trial. FUNDING: Organization for Health Research and Development and the Dutch Cancer Society.
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Adenocarcinoma/tratamiento farmacológico , Neoplasias del Colon/tratamiento farmacológico , Hipertermia Inducida/métodos , Adenocarcinoma/patología , Adenocarcinoma/secundario , Adenocarcinoma/cirugía , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioterapia Adyuvante/métodos , Colectomía/efectos adversos , Colectomía/métodos , Neoplasias del Colon/patología , Neoplasias del Colon/cirugía , Femenino , Humanos , Complicaciones Intraoperatorias , Estimación de Kaplan-Meier , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Oxaliplatino/administración & dosificación , Neoplasias Peritoneales/secundario , Complicaciones PosoperatoriasRESUMEN
PURPOSE: This study has aimed to evaluate the effects of surgery on physical activity (PA), quality of life (QoL), and disease-specific health status, by analyzing the differences between sphincter-preserving surgery (low anterior resection (LAR)) and abdominoperineal resection (APR) among rectal cancer survivors. METHODS: Individuals who were diagnosed with rectal cancer and who underwent an APR or a LAR between 2000 and 2009 were included. The different questionnaires on QoL, disease-specific health status, and physical activity began their surveys in 2010. Differences in QoL, health status, and physical activity were analyzed between the APR group and the LAR group. RESULTS: The study included 905 rectal cancer survivors (LAR, 632; APR, 273). Besides a higher rate of radiotherapy treatment in the APR group (94% vs. 75%, p < 0.001), there were no differences in clinical characteristics or in comorbid conditions between the LAR group and APR group. No significant differences were found in PA level between the patients who had undergone an APR vs. a LAR. Regarding QoL, APR patients did report a worse physical (p = 0.009) and role functioning (p = 0.03), as well as a worse body image (p = 0.001), compared to patients who had undergone a LAR. However, they reported fewer constipation (p = 0.02) and gastrointestinal problems (p = 0.009). Finally, compared to patients who had undergone a LAR with a permanent ostomy, APR patients reported a better body image (p = 0.048) and less stoma-related problems (p = 0.001). CONCLUSIONS: This study showed no differences in PA level among the patients who had undergone an APR versus a LAR. With respect to their QoL, their physical and role functioning seemed to be worse in the APR patients. However, these differences in outcomes resolved when comparing the APR group with patients after a LAR with a permanent ostomy.
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Canal Anal/cirugía , Ejercicio Físico , Estado de Salud , Calidad de Vida , Neoplasias del Recto/cirugía , Anciano , Imagen Corporal , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estomía , Diafragma Pélvico/cirugía , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
BACKGROUND: There is no consensus as to the effects of epidural analgesia on postoperative outcomes after laparoscopy in the context of the Enhanced Recovery Programs. The aim of this study was to evaluate the effects of epidural analgesia on postoperative outcomes after elective laparoscopic sigmoidectomy. METHODS: The use of epidural analgesia was discontinued in elective laparoscopic sigmoidectomy and substituted by the perioperative administration of systemic lidocaine. Data from patients undergoing elective laparoscopic sigmoidectomy between January 2014 and September 2016 was prospectively analysed. Patients with epidural analgesia were compared with patients without, in analgesics administrated postoperatively, length of stay, day of first defecation and mobilisation, and complication and reoperation rates. RESULTS: A total of 160 patients (male 85; female 75), median age 68 (30-92 years), were included. The groups consisted of 80 patients each. Mean length of stay (5.6 vs. 7.2 days, p = 0.03) and day of first mobilisation (mean 1.2 vs. 1.6 days, p = 0.004) were significantly shorter in the group without epidural analgesia. Reoperation rate (7.5 vs. 2.5%) was not statistically different. Complication rate was significantly lower (12.5 vs. 30%, p = 0.007) in the group without epidural. Day of first defecation was shorter in the epidural group (1.4 vs. 1.7 days, p = 0.04). Mean amount of analgesics administrated was not statistically different between groups, except for metamizole, that was administrated more in the group without epidural. CONCLUSIONS: Epidural analgesia did not offer benefits on postoperative analgesia or outcomes after elective laparoscopic sigmoidectomy, causing longer length of stay, later mobilisation and higher complication rate.
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Analgesia Epidural , Analgésicos/administración & dosificación , Colon Sigmoide/cirugía , Lidocaína/administración & dosificación , Dolor Postoperatorio/tratamiento farmacológico , Administración Intravenosa , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos/uso terapéutico , Defecación , Ambulación Precoz , Procedimientos Quirúrgicos Electivos/efectos adversos , Femenino , Humanos , Laparoscopía/efectos adversos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Recuperación de la Función , Factores de TiempoRESUMEN
BACKGROUND: Preoperative low skeletal muscle mass and density are associated with increased postoperative morbidity in patients undergoing curative colorectal cancer (CRC) surgery. However, the long-term effects of low skeletal muscle mass and density remain uncertain. METHODS: Patients with stage I-III CRC undergoing surgery, enrolled in a prospective observational cohort study, were included. Skeletal muscle mass and density were measured on CT. Patients with high and low skeletal muscle mass and density were compared regarding postoperative complications, disease-free survival (DFS), overall survival (OS), and cancer-specific survival (CSS). RESULTS: In total, 816 patients (53.9% males, median age 70) were included; 50.4% had low skeletal muscle mass and 64.1% low density. The severe postoperative complication rate was significantly higher in patients with low versus high skeletal muscle and density (20.9% versus 13.6%, p = 0.006; 20.0% versus 11.8%, p = 0.003). Low skeletal muscle mass (OR 1.91, p = 0.018) and density (OR 1.87, p = 0.045) were independently associated with severe postoperative complications. Ninety-day mortality was higher in patients with low skeletal muscle mass and density compared with patients with high skeletal muscle mass and density (3.6% versus 1.7%, p = 0.091; 3.4% versus 1.0%, p = 0.038). No differences in DFS were observed. After adjustment for covariates such as age and comorbidity, univariate differences in OS and CSS diminished. CONCLUSIONS: Low skeletal muscle mass and density are associated with short-term, but not long-term, outcome in patients undergoing CRC surgery. These findings recommend putting more emphasis on preoperative management of patients at risk for surgical complications, but do not support benefit for long-term outcome.
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Índice de Masa Corporal , Colectomía , Neoplasias Colorrectales/cirugía , Músculo Esquelético/diagnóstico por imagen , Estadificación de Neoplasias , Sarcopenia/epidemiología , Adulto , Anciano , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiología , Comorbilidad/tendencias , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Periodo Posoperatorio , Estudios Prospectivos , Factores de Riesgo , Sarcopenia/diagnóstico , Tasa de Supervivencia/tendencias , Factores de Tiempo , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Surgeon engagement with social media is growing rapidly. Innovative applications in diverse fields of health care are increasingly available. OBJECTIVE: The aim of this review is to explore the current and future applications of social media in surgical training. In addition, risks and barriers of social media engagement are analyzed, and recommendations for professional social media use amongst trainers and trainees are suggested. METHODS: The published, peer-reviewed literature on social media in medicine, surgery and surgical training was reviewed. MESH terms including "social media", "education", "surgical training" and "web applications" were used. RESULTS: Different social media surgical applications are already widely available but limited in use in the trainee's curriculum. E-learning modalities, podcasts, live surgery platforms and microblogs are used for teaching purposes. Social media enables global research collaboratives and can play a role in patient recruitment for clinical trials. The growing importance of networking is emphasized by the increased use of LinkedIn, Facebook, Sermo and other networking platforms. Risks of social media use, such as lack of peer review and the lack of source confirmation, must be considered. Governing surgeon's and trainee's associations should consider adopting and sharing their guidelines for standards of social media use. CONCLUSIONS: Surgical training is changing rapidly and as such, social media presents tremendous opportunities for teaching, training, research and networking. Awareness must be raised on the risks of social media use.
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Cirugía General/educación , Internado y Residencia/métodos , Medios de Comunicación Sociales , RiesgoRESUMEN
BACKGROUND: Transanal minimally invasive surgery (TAMIS) is considered the successor of transanal endoscopic microsurgery (TEMS). It makes use of more readily available laparoscopic instruments and single-port access platforms with similar perioperative, clinical and oncological outcomes. Little is known about quality of life (QoL) outcomes after the use of TAMIS. The aim of this study was to assess QoL after TAMIS in our patients and compare this with QoL in the healthy Dutch population. METHODS: All patients undergoing TAMIS for selected rectal neoplasms between October 2011 and March 2014 were included in this analysis. Patients were studied for a minimal period of 24 months. QoL outcomes were measured using the Short-Form 36 Health Survey (SF-36) questionnaire; faecal continence was measured using the Faecal Incontinence Severity Index questionnaire. Patient reported outcomes were compared to case-matched healthy Dutch control subjects. We hypothesise that undergoing TAMIS will subsequently result in a decreased quality of life in patients compared to healthy individuals. RESULTS: Thirty-seven patients (m:f = 17:20, median 67 years) were included in the current analysis. In four patients (10.8%), postoperative complications occurred. The median follow-up was 36 (range 21-47) months. Postoperative QoL scores are similar comparable to those reported by Dutch healthy controls. Patients reported a statistically significant better QoL score in the 'bodily pain' domain when compared to the controls (81.8 vs. 74.1 points) (p = 0.01). Significant worse QoL scores for the 'social functioning' domain were reported by patients after TAMIS (84.4 vs. 100 points) (p = 0.03). CONCLUSION: TAMIS seems to be a safe technique with postoperative QoL scores similar to that of healthy case matched controls in 3-year follow-up. There seems to be no association between faecal incontinence and reported QoL. Negative effects of TAMIS on social functioning of patients should not be underestimated and should be discussed during preoperative counselling.