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BACKGROUND: In treatment of colon cancer, strict waiting-time targets are enforced, leaving professionals no room to lengthen treatment intervals when advisable, for instance to optimise a patient's health status by means of prehabilitation. Good quality studies supporting these targets are lacking. With this study we aim to establish whether a prolonged treatment interval is associated with a clinically relevant deterioration in overall and cancer free survival. METHODS: This retrospective multicenter non-inferiority study includes all consecutive patients who underwent elective oncological resection of a biopsy-proven primary non-metastatic colon carcinoma between 2010 and 2016 in six hospitals in the Southern Netherlands. Treatment interval was defined as time between diagnosis and surgical treatment. Cut-off points for treatment interval were ≤35 days and ≤49 days. FINDINGS: 3376 patients were included. Cancer recurred in 505 patients (15.0%) For cancer free survival, a treatment interval >35 days and >49 days was non-inferior to a treatment interval ≤35 days. Results for overall survival were inconclusive, but no association was found. CONCLUSION: For cancer free survival, a prolonged treatment interval, even over 49 days, is non-inferior to the currently set waiting-time target of ≤35 days. Therefore, the waiting-time targets set as fundamental objective in current treatment guidelines should become directional instead of strict targets.
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Neoplasias do Colo , Recidiva Local de Neoplasia , Humanos , Neoplasias do Colo/cirurgia , Países Baixos/epidemiologia , Estudos RetrospectivosRESUMO
OBJECTIVE: Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND: Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS: The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS: After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS: SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.
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Tratamento Conservador , Terapia por Estimulação Elétrica , Adulto , Adolescente , Humanos , Qualidade de Vida , Constipação Intestinal/terapia , Terapia por Estimulação Elétrica/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: A variety of definitions for a clinical near-complete response after neoadjuvant (chemo) radiotherapy for rectal cancer are currently used. This variety leads to inconsistency in clinical practice, long-term outcome, and trial enrollment. OBJECTIVE: The aim of this study was to reach expert-based consensus on the definition of a clinical near-complete response after (chemo) radiotherapy. DESIGN: A modified Delphi process, including a systematic review, 3 surveys, and 2 meetings, was performed with an international expert panel consisting of 7 surgeons and 4 radiologists. The surveys consisted of individual features, statements, and feature combinations (endoscopy, T2-weighted MRI, and diffusion-weighted MRI). SETTING: The modified Delphi process was performed in an online setting; all 3 surveys were completed online by the expert panel, and both meetings were hosted online. MAIN OUTCOME MEASURES: The main outcome was to reach consensus (80% or more agreement). RESULTS: The expert panel reached consensus on a 3-tier categorization of the near-complete response category based on the likelihood of the response to evolve into a clinical complete response after a longer waiting interval. The panelists agreed that a near-complete response is a temporary entity only to be used in the first 6 months after (chemo)radiotherapy. Furthermore, consensus was reached that the lymph node status should be considered when deciding on a near-complete response and that biopsies are not always needed when a near-complete response is found. No consensus was reached on whether primary staging characteristics have to be taken into account when deciding on a near-complete response. LIMITATIONS: This 3-tier subcategorization is expert-based; therefore, there is no supporting evidence for this subcategorization. Also, it is unclear whether this subcategorization can be generalized into clinical practice. CONCLUSIONS: Consensus was reached on the use of a 3-tier categorization of a near-complete response, which can be helpful in daily practice as guidance for treatment and to inform patients with a near-complete response on the likelihood of successful organ preservation. See Video Abstract. UN CONSENSO INTERNACIONAL BASADO EN EXPERTOS ACERCA DE LA DEFINICIN DE UNA RESPUESTA CLNICA CASI COMPLETA DESPUS DE QUIMIORADIOTERAPIA NEOADYUVANTE CONTRA EL CNCER DE RECTO: ANTECEDENTES:Actualmente, se utilizan una variedad de definiciones para una respuesta clínica casi completa después de quimioradioterapia neoadyuvante contra el cáncer de recto. Esta variedad resulta en inconsistencia en la práctica clínica, los resultados a largo plazo y la inscripción en ensayos.OBJETIVO:El objetivo de este estudio fue llegar a un consenso de expertos sobre la definición de una respuesta clínica casi completa después de quimioradioterapia.DISEÑO:Se realizó un proceso Delphi modificado que incluyó una revisión sistemática, 3 encuestas y 2 reuniones con un panel internacional de expertos compuesto por siete cirujanos y 4 radiólogos. Las encuestas consistieron en características individuales, declaraciones y combinaciones de características (endoscopía, T2W-MRI y DWI).AJUSTE:El proceso Delphi modificado se realizó en un entorno en línea; el panel de expertos completó las tres encuestas en línea y ambas reuniones se realizaron en línea.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue llegar a un consenso (≥80% de acuerdo).RESULTADOS:El panel de expertos llegó a un consenso sobre una categorización de tres niveles de la categoría de respuesta casi completa basada en la probabilidad de que la respuesta evolucione hacia una respuesta clínica completa después de un intervalo de espera más largo. Los panelistas coincidieron en que una respuesta casi completa es una entidad temporal que sólo debe utilizarse en los primeros 6 meses después de la quimioradioterapia. Además, se llegó a un consenso en que se debe considerar el estado de los nódulos linfáticos al decidir sobre una respuesta casi completa y que no siempre se necesitan biopsias cuando se encuentra una respuesta casi completa. No se llegó a un consenso sobre si se deben tener en cuenta las características primarias de estadificación al decidir una respuesta casi completa.LIMITACIONES:Esta subcategorización de 3 niveles está basada en expertos; por lo tanto, no hay evidencia que respalde esta subcategorización. Además, no está claro si esta subcategorización puede generalizarse a la práctica clínica.CONCLUSIONES:Se alcanzó consenso sobre el uso de una categorización de 3 niveles de una respuesta casi completa que puede ser útil en la práctica diaria como guía para el tratamiento y para informar a los pacientes con una respuesta casi completa sobre la probabilidad de una preservación exitosa del órgano. (Traducción - Dr. Aurian Garcia Gonzalez).
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Consenso , Técnica Delphi , Terapia Neoadjuvante , Neoplasias Retais , Humanos , Neoplasias Retais/terapia , Neoplasias Retais/patologia , Neoplasias Retais/radioterapia , Terapia Neoadjuvante/métodos , Quimiorradioterapia/métodos , Resultado do Tratamento , Imagem de Difusão por Ressonância Magnética/métodosRESUMO
AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.
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Constipação Intestinal , Análise Custo-Benefício , Terapia por Estimulação Elétrica , Humanos , Constipação Intestinal/terapia , Constipação Intestinal/economia , Terapia por Estimulação Elétrica/economia , Terapia por Estimulação Elétrica/métodos , Terapia por Estimulação Elétrica/efeitos adversos , Resultado do Tratamento , Adulto , Plexo Lombossacral , Feminino , Criança , Ensaios Clínicos Controlados Aleatórios como Assunto , Masculino , Sacro/inervação , Pessoa de Meia-Idade , Trânsito GastrointestinalRESUMO
PURPOSE: To assess the association of postoperative C-reactive protein (CRP), leucocytes and vital signs in the first three postoperative days (PODs) with major complications after oncological colorectal resections in a tertiary referral centre for colorectal cancer in The Netherlands. METHODS: A retrospective cohort study, including 594 consecutive patients who underwent an oncological colorectal resection at Maastricht University Medical Centre between January 2016 and December 2020. Descriptive analyses of patient characteristics were performed. Logistic regression models were used to assess associations of leucocytes, CRP and Modified Early Warning Score (MEWS) at PODs 1-3 with major complications. Receiver operating characteristic curve analyses were used to establish cut-off values for CRP. RESULTS: A total of 364 (61.3%) patients have recovered without any postoperative complications, 134 (22.6%) patients have encountered minor complications and 96 (16.2%) developed major complications. CRP levels reached their peak on POD 2, with a mean value of 155 mg/L. This peak was significantly higher in patients with more advanced stages of disease and patients undergoing open procedures, regardless of complications. A cut-off value of 170 mg/L was established for CRP on POD 2 and 152 mg/L on POD 3. Leucocytes and MEWS also demonstrated a peak on POD 2 for patients with major complications. CONCLUSIONS: Statistically significant associations were found for CRP, Δ CRP, Δ leucocytes and MEWS with major complications on POD 2. Patients with CRP levels ≥ 170 mg/L on POD 2 should be carefully evaluated, as this may indicate an increased risk of developing major complications.
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Neoplasias Colorretais , Cirurgia Colorretal , Humanos , Proteína C-Reativa/metabolismo , Estudos Retrospectivos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Curva ROC , Neoplasias Colorretais/diagnóstico , Sinais Vitais , BiomarcadoresRESUMO
Intussusception, the invagination of a bowel segment into an adjacent segment, occurs in 5% of adult patients with an obstruction of the bowel. It is often seen as a result of obstructive defecation syndrome or malignancy. However, a sigmoidal malignancy as lead point is rare. Symptoms in adults are less specific than in children, which makes preoperative diagnosis challenging. An 85-year-old female presented with bright red anal blood loss. A large palpable mass was found during rectal examination. A computed tomography was performed during workup, which showed a 'target-sign' on the location of the lesion. An intussusception of the sigmoid into the rectum was seen over the length of 15 cm. This particular type of intussusception is extremely rare. When a neoplasm is suspected to be the lead point, an oncological resection is recommended. We performed a total mesorectal excision, after which the patient had an uneventful recovery.
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BACKGROUND: In rectal cancer, watch and wait for patients with a cCR after neoadjuvant treatment has an established evidence base. However, there is a lack of consensus on the definition and management of a near-cCR. This study aimed to compare outcomes in patients who achieved a cCR at first reassessment versus later reassessment. METHODS: This registry study included patients from the International Watch & Wait Database. Patients were categorized as having a cCR at first reassessment or at later reassessment (that is near-cCR at first reassessment) based on MRI and endoscopy. Organ preservation, distant metastasis-free survival, and overall survival rates were calculated. Subgroup analyses were done for near-cCR groups based on the response evaluation according to modality. RESULTS: A total of 1010 patients were identified. At first reassessment, 608 patients had a cCR; 402 had a cCR at later reassessment. Median follow-up was 2.6 years for patients with a cCR at first reassessment and 2.9 years for those with a cCR at later reassessment. The 2-year organ preservation rate was 77.8 (95 per cent c.i. 74.2 to 81.5) and 79.3 (75.1 to 83.7) per cent respectively (P = 0.499). Similarly, no differences were found between groups in distant metastasis-free survival or overall survival rate. Subgroup analyses showed a higher organ preservation rate in the group with a near-cCR categorized exclusively by MRI. CONCLUSION: Oncological outcomes for patients with a cCR at later reassessment are no worse than those of patients with a cCR at first reassessment.
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Terapia Neoadjuvante , Neoplasias Retais , Humanos , Resultado do Tratamento , Conduta Expectante , Recidiva Local de Neoplasia , QuimiorradioterapiaRESUMO
AIM: Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs. METHODS: Seventeen patients (11 women, six men) received a replacement adaptor with a follow-up of 6 months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien-Dindo classification. RESULTS: Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien-Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien-Dindo Grade II) and one patient had persisting pocket pain (Clavien-Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test. CONCLUSION: The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.
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Terapia por Estimulação Elétrica , Próteses e Implantes , Masculino , Humanos , Feminino , Estudos Retrospectivos , Abdome , Dor , Eletrodos Implantados , Resultado do TratamentoRESUMO
AIM: The aim of this study was to translate the Dutch patient-reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS) to English and perform a cross-cultural validation. METHOD: The ISPOR good practice guidelines for the cross-cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM-HISS. RESULTS: Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM-HISS was reached. Interviews were conducted with 10 native English-speaking HD patients (30% female), with a mean age of 44 years (24-83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM-HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics. CONCLUSION: The translated English language PROM-HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment.
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Comparação Transcultural , Satisfação do Paciente , Humanos , Feminino , Adulto , Masculino , Reprodutibilidade dos Testes , Idioma , Traduções , Medidas de Resultados Relatados pelo Paciente , Satisfação Pessoal , Inquéritos e QuestionáriosRESUMO
AIM: In this study we aimed to assess the responsiveness of the symptom score of the recently developed Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS). Furthermore, the minimally relevant difference (MRD) was determined. METHOD: The responsiveness of PROM-HISS was tested using a criterion-based (i.e. anchor) and construct-based (i.e. hypotheses testing) approach. Patients with haemorrhoidal disease (HD) completed the PROM-HISS before and 1 week after treatment in hospital. A global self-assessment of change question (SCQ) was administered 1-week after treatment and functioned as the criterion. The following analyses were performed: (1) correlation between the PROM-HISS symptom score and the criterion (SCQ) and (2) hypotheses testing. The MRD was determined as change in symptoms of the subgroup reporting 'somewhat fewer complaints' on the SCQ. RESULTS: Between February and August 2022, 94 patients with grade II-IV HD from three hospitals were included. The correlation between the SCQ and a change on the PROM-HISS symptom score was 0.595 indicating that an improvement on the SCQ corresponds to an improvement on the PROM-HISS symptom score. As hypothesized, the mean change in PROM-HISS scores was significantly different between subgroups of patients based on their SCQ responses. Patients reporting a small change in HD symptoms on the SCQ corresponded to a mean change of 0.3 on the PROM-HISS symptom score. CONCLUSION: The PROM-HISS symptom score is a responsive instrument as it identifies change in HD symptoms because of treatment. The estimated MRD of 0.3 can be used to inform clinical research and practice.
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Hemorroidas , Humanos , Inquéritos e Questionários , Hemorroidas/diagnóstico , Hemorroidas/terapia , Satisfação do Paciente , Medidas de Resultados Relatados pelo Paciente , Satisfação PessoalRESUMO
OBJECTIVE: To describe a suitable alternative technique for reconstruction of the pelvic floor after extensive resection. To review our outcomes of gluteal VY plasty in the reconstruction of the pelvic floor after extensive abdominoperineal resection (conventional or extralevator abdominoperineal resection, total pelvic exenteration, or salvage surgery). DESIGN: Retrospective cohort study. SETTING: An academic hospital and tertiary referral centre for the treatment of locally advanced or locally recurrent rectal cancer, and salvage surgery in The Netherlands. PATIENTS: Forty-one consecutive patients who underwent a pelvic floor reconstruction with gluteal VY plasty at Maastricht University Medical Centre between January 2017 and February 2021 were included. The minimum duration of follow-up was 2 years. MAIN OUTCOME MEASURES: Perineal herniation is the primary outcome measure. Furthermore, the occurrence of minor and major postoperative complications and long-term outcomes were retrospectively assessed. RESULTS: Thirty-five patients (85.4%) developed one or more complications of whom twenty-one patients experienced minor complications and fourteen patients developed major complications. Fifty-seven percent of complications was not related to the VY reconstruction. Six patients (14.6%) recovered without any postoperative complications during follow-up. Three patients developed a perineal hernia. CONCLUSIONS: A gluteal VY plasty is a suitable technique for reconstruction of the pelvic floor after extensive perineal resections resulting in a low perineal hernia rate, albeit the complication rate remains high in this challenging group of patients.
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Hérnia Abdominal , Exenteração Pélvica , Protectomia , Neoplasias Retais , Humanos , Estudos Retrospectivos , Recidiva Local de Neoplasia/cirurgia , Protectomia/efeitos adversos , Neoplasias Retais/cirurgia , Complicações Pós-Operatórias/etiologia , Hérnia Abdominal/cirurgia , Resultado do Tratamento , Períneo/cirurgiaRESUMO
OBJECTIVE: Although increasing evidence suggests a central mechanism of action for sacral neuromodulation, the exact mechanism remains unclear. We set up a scanning paradigm to measure brain activation related to various stages of rectal filling using rectal balloon distention. MATERIALS AND METHODS: Six healthy volunteers underwent rectal balloon distention during MRI scanning at a 1.5T scanner with a Tx/Rx head coil. MR images were collected at four levels of distention: empty balloon (EB), first sensation volume (FSV), desire to defecate volume (DDV), maximum tolerable volume (MTV). Data were analyzed using BrainVoyager 20.4. Whole brain and ROI-based fixed-effects general linear model analyses were performed on the fMRI time-course data from all participants. RESULTS: Rectal filling until FSV evoked the most blood-oxygen-level-dependent responses in several clusters throughout the cortex, followed by the responses evoked by rectal filling until DDV. Interestingly, rectal filling until MTV evoked negative responses compared to baseline throughout the cortex. No negative side effects were found. DISCUSSION: This study shows that a standardized paradigm for functional MRI combined with rectal filling is feasible and safe in healthy volunteers and is ready to be used in fecal incontinent patients to assess whether their brain activity differs from healthy controls.
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Encéfalo , Reto , Humanos , Projetos Piloto , Voluntários Saudáveis , Estudos de Viabilidade , Reto/diagnóstico por imagem , Reto/fisiologia , Encéfalo/diagnóstico por imagemRESUMO
BACKGROUND: The COVID-19 pandemic caused disruption of regular healthcare leading to reduced hospital attendances, repurposing of surgical facilities, and cancellation of cancer screening programmes. This study aimed to determine the impact of COVID-19 on surgical care in the Netherlands. METHODS: A nationwide study was conducted in collaboration with the Dutch Institute for Clinical Auditing. Eight surgical audits were expanded with items regarding alterations in scheduling and treatment plans. Data on procedures performed in 2020 were compared with those from a historical cohort (2018-2019). Endpoints included total numbers of procedures performed and altered treatment plans. Secondary endpoints included complication, readmission, and mortality rates. RESULTS: Some 12 154 procedures were performed in participating hospitals in 2020, representing a decrease of 13.6 per cent compared with 2018-2019. The largest reduction (29.2 per cent) was for non-cancer procedures during the first COVID-19 wave. Surgical treatment was postponed for 9.6 per cent of patients. Alterations in surgical treatment plans were observed in 1.7 per cent. Time from diagnosis to surgery decreased (to 28 days in 2020, from 34 days in 2019 and 36 days in 2018; P < 0.001). For cancer-related procedures, duration of hospital stay decreased (5 versus 6 days; P < 0.001). Audit-specific complications, readmission, and mortality rates were unchanged, but ICU admissions decreased (16.5 versus 16.8 per cent; P < 0.001). CONCLUSION: The reduction in the number of surgical operations was greatest for those without cancer. Where surgery was undertaken, it appeared to be delivered safely, with similar complication and mortality rates, fewer admissions to ICU, and a shorter hospital stay.
COVID-19 has had a significant impact on healthcare worldwide. Hospital visits were reduced, operating facilities were used for COVID-19 care, and cancer screening programmes were cancelled. This study describes the impact of the COVID-19 pandemic on Dutch surgical healthcare in 2020. Patterns of care in terms of changed or delayed treatment are described for patients who had surgery in 2020, compared with those who had surgery in 20182019. The study found that mainly non-cancer surgical treatments were cancelled during months with high COVID-19 rates. Outcomes for patients undergoing surgery were similar but with fewer ICU admissions and shorter hospital stay. These data provide no insight into the burden endured by patients who had postponed or cancelled operations.
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COVID-19 , Humanos , Países Baixos , Pandemias , Hospitais , HospitalizaçãoRESUMO
AIM: The aim of this study was to assess the clinical and oncological outcome of a selected group of stage IV rectal cancer patients managed by the watch-and-wait approach following a (near-)complete response of the primary rectal tumour after radiotherapy. METHOD: Patients registered in the Dutch watch-and-wait registry since 2004 were selected when diagnosed with synchronous stage IV rectal cancer. Data on patient characteristics, treatment details, follow-up and survival were collected. The 2-year local regrowth rate, organ-preservation rate, colostomy-free rate, metastatic progression-free rate and 2- and 5-year overall survival were analysed. RESULTS: After a median follow-up period of 35 months, local regrowth was observed in 17 patients (40.5%). Nine patients underwent subsequent total mesorectal excision, resulting in a permanent colostomy in four patients. The 2-year local regrowth rate was 39.9%, the 2-year organ-preservation rate was 77.1%, the 2-year colostomy-free rate was 88.1%, and the 2-year metastatic progression-free rate was 46.7%. The 2- and 5-year overall survival rates were 92.0% and 67.5%. CONCLUSION: The watch-and-wait approach can be considered as an alternative to total mesorectal excision in a selected group of stage IV rectal cancer patients with a (near-)complete response following pelvic radiotherapy. Despite a relatively high regrowth rate, total mesorectal excision and a permanent colostomy can be avoided in the majority of these patients.
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Terapia Neoadjuvante , Neoplasias Retais , Quimiorradioterapia Adjuvante , Humanos , Recidiva Local de Neoplasia , Neoplasias Retais/radioterapia , Neoplasias Retais/cirurgia , Conduta ExpectanteRESUMO
BACKGROUND: Accurate response evaluation is necessary to select complete responders (CRs) for a watch-and-wait approach. Deep learning may aid in this process, but so far has never been evaluated for this purpose. The aim was to evaluate the accuracy to assess response with deep learning methods based on endoscopic images in rectal cancer patients after neoadjuvant therapy. METHODS: Rectal cancer patients diagnosed between January 2012 and December 2015 and treated with neoadjuvant (chemo)radiotherapy were retrospectively selected from a single institute. All patients underwent flexible endoscopy for response evaluation. Diagnostic performance (accuracy, area under the receiver operator characteristics curve (AUC), positive- and negative predictive values, sensitivities and specificities) of different open accessible deep learning networks was calculated. Reference standard was histology after surgery, or long-term outcome (>2 years of follow-up) in a watch-and-wait policy. RESULTS: 226 patients were included for the study (117(52%) were non-CRs; 109(48%) were CRs). The accuracy, AUC, positive- and negative predictive values, sensitivity and specificity of the different models varied from 0.67-0.75%, 0.76-0.83%, 67-74%, 70-78%, 68-79% to 66-75%, respectively. Overall, EfficientNet-B2 was the most successful model with the highest diagnostic performance. CONCLUSIONS: This pilot study shows that deep learning has a modest accuracy (AUCs 0.76-0.83). This is not accurate enough for clinical decision making, and lower than what is generally reported by experienced endoscopists. Deep learning models can however be further improved and may become useful to assist endoscopists in evaluating the response. More well-designed prospective studies are required.
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Aprendizado Profundo , Neoplasias Retais , Quimiorradioterapia/métodos , Endoscopia , Humanos , Terapia Neoadjuvante/métodos , Recidiva Local de Neoplasia/cirurgia , Projetos Piloto , Neoplasias Retais/tratamento farmacológico , Neoplasias Retais/terapia , Estudos Retrospectivos , Resultado do Tratamento , Conduta Expectante/métodosRESUMO
OBJECTIVE AND BACKGROUND: Watch-and-wait approach in rectal cancer relies on the identification of a clinical complete response (CR) after neoadjuvant (chemo)radiotherapy. This is mainly performed by rectal examination, magnetic resonance imaging, and endoscopy. Endoscopy has been less well studied, and the objective of the study is to assess the diagnostic value of endoscopy and the predictive value of endoscopic features for the identification of CR. PATIENTS AND METHODS: A total of 161 patients with primary rectal cancer undergoing flexible sigmoidoscopy for response assessment after neoadjuvant (chemo)radiotherapy between January 2012 and December 2015 at a single institution were evaluated retrospectively. Three independent readers scored endoscopic features and a confidence level score for a CR. Diagnostic performance of endoscopy and positive predictive value (PPV) of endoscopic features for a CR were calculated. If available, biopsy results were revealed to the reader and a change in confidence level was noted. Reference standard was histology after surgery, or long-term outcome in a watch-and-wait policy. RESULTS: Median time to endoscopy was 9 (interquartile range 8-12) weeks. Area under the receiver operator characteristic curve, sensitivity, specificity, PPV, and negative predictive value for a CR were 0.80 to 0.84, 72% to 94%, 61% to 85%, 63% to 78% and 80% to 89%, respectively. A flat scar was the most predictive feature of a CR (PPV 70%-80%). The PPV of small flat ulcers and large flat ulcers were 40% to 50% and 29% to 33%, respectively. The addition of biopsy results led to a significant change in confidence level score in 4% to 13% of patients. CONCLUSIONS: More than 70% of the patients with a luminal CR after neoadjuvant treatment for rectal cancer can be identified by endoscopy at ±9 weeks. Together with findings on digital rectal examination (DRE) and magnetic resonance imaging, specific endoscopic features can be used to select patients for an extended observation period to select for organ preservation.
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Quimiorradioterapia , Endoscopia Gastrointestinal , Terapia Neoadjuvante , Neoplasias Retais/patologia , Neoplasias Retais/terapia , Idoso , Biópsia , Exame Retal Digital , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias/métodos , Neoplasias Retais/diagnóstico por imagem , Estudos RetrospectivosRESUMO
AIM: Many of the current follow-up schedules in a watch-and-wait approach include very frequent MRI and endoscopy examinations to ensure early detection of local regrowth (LR). The aim of this study was to analyse the occurrence and detection of LR in a watch-and-wait cohort and to suggest a more efficient follow-up schedule. METHOD: Rectal cancer patients with a clinical complete response after neoadjuvant therapy were prospectively and retrospectively included in a multicentre watch-and-wait registry between 2004 and 2018, with the current follow-up schedule with 3-monthly endoscopy and MRI in the first year and 6 monthly thereafter. A theoretical comparison was constructed for the detection of LR in the current follow-up schedule against four other hypothetical schedules. RESULTS: In all, 50/304 (16%) of patients developed a LR. The majority (98%) were detected at ≤2 years, located in the lumen (94%) and were visible on endoscopy (88%). The theoretical comparison of the different hypothetical schedules suggests that the optimal follow-up schedule should focus on the first 2 years with 3-monthly endoscopy and 3-6 monthly MRI. Longer intervals in the first 2 years will cause delays in diagnosis of LR ranging from 0 to 5 months. After 2 years, increasing the interval from 6 to 12 months did not cause important delays. CONCLUSION: The optimal follow-up schedule for a watch-and-wait policy in patients with a clinical complete response after chemoradiation for rectal cancer should include frequent endoscopy and to a lesser degree MRI in the first 2 years. Longer intervals, up to 12 months, can be considered after 2 years.
Assuntos
Terapia Neoadjuvante , Neoplasias Retais , Seguimentos , Humanos , Recidiva Local de Neoplasia , Neoplasias Retais/diagnóstico por imagem , Neoplasias Retais/terapia , Estudos Retrospectivos , Conduta ExpectanteRESUMO
AIM: Patient-reported outcome measures (PROMs) are increasingly being used in routine cancer care to evaluate treatment and monitor symptoms, function and other aspects of quality of life (QoL). There is no suitable PROM for rectal cancer patients following a watch-and-wait (W&W) programme. Insight into patient experiences with this programme is an essential step in the development of a PROM. The aim of this qualitative study was to provide insights into the most important functional outcomes and QoL features experienced by patients during our W&W programme. METHOD: Patients with locally advanced rectal cancer who are enrolled in the W&W programme in the Netherlands were interviewed by telephone using a semistructured interview guide. All interviews were digitally audio-recorded, transcribed verbatim and coded. A thematic approach was used to analyse the data and identify themes and subthemes of importance to patients. RESULTS: Eighteen patients were interviewed (78% male, mean age 68 years, range 52-83 years). Physical complaints after treatment were present, most notably gastrointestinal problems, neuropathy and fatigue. Furthermore, patients were anxious about a possible recurrence, had a fear of surgery or a stoma, or were experiencing a general feeling of apprehension in daily life. Many patients had different coping mechanisms, such as acceptance, and there were few limitations in daily life. CONCLUSION: We identified important functional outcomes, such as gastrointestinal complaints, fatigue and neuropathy, in patients who were enrolled in this W&W programme. Furthermore, an emotional burden and unmet needs were reported by these patients. These findings can be used to improve clinical practice and inform the development of a PROM.
Assuntos
Qualidade de Vida , Neoplasias Retais , Idoso , Idoso de 80 Anos ou mais , Efeitos Psicossociais da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante , Recidiva Local de Neoplasia , Políticas , Neoplasias Retais/terapia , Conduta ExpectanteRESUMO
OBJECTIVE: The aim of this study was to evaluate whether magnetic resonance imaging (MRI) can accurately identify poor responders after chemoradiotherapy (CRT) who will need to go straight to surgery, and to evaluate whether results are reproducible among radiologists with different levels of expertise. METHODS: Seven independent readers with different levels of expertise retrospectively evaluated the restaging MRIs (T2-weighted + diffusion-weighted imaging [T2W + DWI]) of 62 patients and categorized them as (1) poor responders - highly suspicious of tumor; (2) intermediate responders - tumor most likely; and (3) good - potential (near) complete responders. The reference standard was histopathology after surgery (or long-term follow-up in the case of a watch-and-wait program). RESULTS: Fourteen patients were complete responders and 48 had residual tumor. The median percentage of patients categorized by the seven readers as 'poor', 'intermediate', and 'good' responders was 21% (range 11-37%), 50% (range 23-58%), and 29% (range 23-42%), respectively. The vast majority of poor responders had histopathologically confirmed residual tumor (73% ypT3-4), with a low rate (0-5%) of 'missed complete responders'. Of the 14 confirmed complete responders, a median percentage of 71% were categorized in the MR-good response group and 29% were categorized in the MR-intermediate response group. CONCLUSIONS: Radiologists of varying experience levels should be able to use MRI to identify the ± 20% subgroup of poor responders who will definitely require surgical resection after CRT. This may facilitate more selective use of endoscopy, particularly in general settings or in centers with limited access to endoscopy.
Assuntos
Neoplasias , Preservação de Órgãos , Quimiorradioterapia , Humanos , Imageamento por Ressonância Magnética , Terapia Neoadjuvante , Neoplasias/diagnóstico por imagem , Neoplasias/cirurgia , Neoplasias/terapia , Seleção de Pacientes , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Fecal incontinence is a common and debilitating condition, of which the prevalence increases with age. Several medical and minimally invasive treatment modalities are available. However, for patients with greater sphincter defects, these treatments are often not sufficient. For these patients, the artificial bowel sphincter could be an alternative to colostomy. The artificial bowel sphincter has proven to be effective in the short term. Less is known whether the benefits sustain over time. OBJECTIVE: The aim of this study was to assess the long-term outcome of the artificial bowel sphincter in patients with refractory fecal incontinence. DESIGN: A retrospective record review was conducted in conjunction with questionnaires. SETTING: This study was conducted in a tertiary hospital setting. MAIN OUTCOME MEASURES: The primary end point was any complication. The secondary end point was fecal loss. PATIENTS: The patients included were adults experiencing severe fecal incontinence treated with artificial bowel sphincter, operated on between 1997 and 2014. RESULTS: Sixty-three patients were included in this study. After a median follow-up of 57 months (range, 1-198), the device had been explanted in 31 patients (49.2%; 95% CI, 36.5-62.0). In total, 101 reoperations were conducted, ranging from 1 to 6 reoperations per patient. The main reasons for revision were device failure and infection. At 5 years follow-up, 80% of the cohort had experienced a complication requiring surgery. Twenty-two (35%) patients had restored continence. LIMITATIONS: This study was limited by its retrospective design and subjective secondary outcome. CONCLUSION: Patients with severe end-stage fecal incontinence can benefit from artificial bowel sphincter, but this requires a large number of reoperations, and at least 20% of patients will eventually have a colostomy. Therefore, careful patient selection and the involvement of patients in decision making regarding the potential benefits and limitations of this technique are paramount. See Video Abstract at http://links.lww.com/DCR/B242. EL ESFÍNTER INTESTINAL ARTIFICIAL EN EL TRATAMIENTO DE LA INCONTINENCIA FECAL, COMPLICACIONES A LARGO PLAZO: La incontinencia fecal es una condición común y debilitante, cuya prevalencia aumenta con la edad. Se encuentran disponibles varias modalidades de tratamiento médico y mínimamente invasivo. Sin embargo, para pacientes con defectos del esfínter mayores, estos tratamientos a menudo no son suficientes. Para estos pacientes, el esfínter intestinal artificial (ABS) podría ser una alternativa a la colostomía. El esfínter intestinal artificial demostró ser efectivo a corto plazo. Se sabe menos si los beneficios se mantienen a lo largo del tiempo.El objetivo de este estudio fue evaluar el resultado a largo plazo del esfínter intestinal artificial en pacientes con incontinencia fecal refractaria.Se realizó una revisión retrospectiva de los registros junto con los cuestionarios.Realizado en un entorno de hospital de tercel nivel.El punto final primario fue cualquier complicación, el punto final secundario fue la pérdida fecal.Los pacientes incluidos fueron adultos que padecían incontinencia fecal severa tratados con esfínter intestinal artificial, operados entre 1997 y 2014.Sesenta y tres pacientes fueron incluidos en este estudio. Después de una mediana de seguimiento de 57 meses (rango 1-198), el dispositivo había sido explantado en 31 pacientes (49.2%; 95CI 36.5-62.0). En total, se realizaron 101 reoperaciones, que oscilaron de una a seis reoperaciones por paciente. Las principales razones para la revisión fueron la falla del dispositivo y la infección. A los cinco años de seguimiento, el 80% de la cohorte había experimentado una complicación que requería cirugía. 22 pacientes habían recuperado la continencia (35%).Diseño retrospectivo y resultado secundario subjetivo.Los pacientes con incontinencia fecal grave en etapa terminal pueden beneficiarse del esfínter intestinal artificial, pero esto requiere una gran cantidad de reoperaciones y al menos el 20% de los pacientes eventualmente tendrán una colostomía. Por lo tanto, la selección cuidadosa del paciente y la participación de los pacientes en la toma de decisiones con respecto a los posibles beneficios y limitaciones de esta técnica es primordial. Consulte Video Resumen en http://links.lww.com/DCR/B242.