The aim of this study was to establish the oncological and functional results of organ preservation with a watch-and-wait approach (W&W) and selective transanal endoscopic microsurgery (TEM) in ...patients with a clinical complete or near-complete response (cCR) after neoadjuvant chemoradiation for rectal cancer.
Between 2004 and 2014, organ preservation was offered if response assessment with digital rectal examination, endoscopy, and MRI showed (near) cCR. Watch-and-wait was offered for cCR, and two options were offered for near cCR: TEM or reassessment after three months. Follow-up included endoscopy and MRIs every three months during the first year, and every six months thereafter. Long-term outcome was assessed with Kaplan-Meier curves. Functional outcome was assessed with colostomy-free survival and Vaizey incontinence score (0 = perfect continence, 24 = totally incontinent).
One hundred patients were included, with median follow-up of 41.1 months. Sixty-one had cCR at initial response assessment. Thirty-nine had near cCR, of whom 24 developed cCR at the second assessment and 15 patients underwent TEM (9 ypT0, 1 ypT1, 5 ypT2). Fifteen patients developed a local regrowth (12 luminal, 3 nodal), all salvageable and within 25 months. Five patients developed metastases, and five patients died. Three-year overall survival was 96.6% (95% confidence interval CI = 89.9% to 98.9%), distant metastasis-free survival was 96.8% (95% CI = 90.4% to 99.0%), local regrowth-free survival was 84.6% (95% CI = 75.8% to 90.5%), and disease-free survival was 80.6% (95% CI = 70.9% to 87.4%). Colostomy-free survival was 94.8% (95% CI = 88.0% to 97.8%), with a good continence after watch-and-wait (Vaizey = 3.4, SD = 3.9) and moderate after TEM (Vaizey = 9.7, SD = 5.1).
Organ preservation appears oncologically safe for selected rectal cancer patients with a cCR or near cCR after neoadjuvant chemoradiation when applying strict selection criteria and frequent follow-up, including endoscopy and MRI. The low colostomy rate and the good long-term functional outcome warrant discussing this option with the patient as an alternative to major surgery.
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.
The impact of COVID-19 in healthcare systems globally was unprecedented leading to cancelations of most planned surgical activities. Surgical trainees were redeployed to Intensive Care and Emergency ...units supporting urgent and unplanned care on COVID-19 patients. Theater exposure, crucial part of surgical training, was reduced to minimal since elective cases were postponed, and emergency operating was carried out by consultants only. Surgical research has also been severely hit with most of the clinical trials been postponed. Teaching activities as well as national and international congresses and surgical courses important tools for continuous professional development were canceled.
The primary aim of our study was to summarize the changes in surgical training during the pandemic. This was followed by a review of the existing social media platforms, video-conferencing platforms along with the role of the social media in surgical training. The crucial role of simulation in surgical training was explored and alternative ways of training with engagement of the feedback mechanisms were proposed. The secondary aim was to highlight possible novel educational strategies for the forthcoming post-COVID-19 era.
The "new" era forced the educational boards to reexamine training curriculums. Innovation strategies and cooperation on the part of surgical residency programs is crucial. Strong leadership is needed, on the part of the education bodies with restructuring of the surgical programmes to accommodate alternative ways of training is necessary to maintain rigorous standards of education and training.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Purpose
In current cancer care, there is a growing debate about the value of using patient-reported outcome measures (PROMs) in daily clinical follow-up. A systematic review of the literature was ...conducted to assess the evidence of the effectiveness of the routine use of PROMs in daily cancer care in terms of patient outcomes, patient experiences and process indicators and to identify the effect of giving feedback about PROM findings to patients and/or health care professionals (HCPs).
Methods
A systematic search was performed. Studies were eligible for inclusion when they (1) used a PROM as an intervention, with or without feedback to patients and/or HCPs, compared with not using a PROM, and (2) used a PROM as an intervention with feedback to patients and/or HCPs, compared with using a PROM without giving feedback to patients and/or HCPs.
Results
After screening of 8341 references, 22 original studies met the inclusion criteria. Most studies found a positive effect on survival, symptoms, HRQoL and patient satisfaction. In general, using feedback to patient and/or HCPs about the PROM results led to better symptom control, HRQoL, patient satisfaction and patient-doctor communication. The majority of included studies had insufficient power to detect significant differences in the outcomes assessed.
Conclusion
This review shows that predominantly positive findings were found in the use of a PROM in daily cancer care. Additionally, more positive effects were seen when feedback is provided to patient and/or health care professionals, and it is thus highly recommended that this is always done.
BACKGROUND:Fifteen to twenty percent of patients with locally advanced rectal cancer have a clinical complete response after chemoradiation therapy. These patients can be offered nonoperative ...organ-preserving treatment, the so-called watch-and-wait policy. The main goal of this watch-and-wait policy is an anticipated improved quality of life and functional outcome in comparison with a total mesorectal excision, while maintaining a good oncological outcome.
OBJECTIVE:The aim of this study was to compare the quality of life of watch-and-wait patients with a matched-controlled group of patients who underwent chemoradiation and surgery (total mesorectal excision group).
DESIGN:This was a matched controlled study.
SETTINGS:This study was conducted at multiple centers.
PATIENTS:The study population consisted of 2 groups41 patients after a watch-and-wait policy and 41 matched patients after chemoradiation and surgery. Patients were matched on sex, age, tumor stage, and tumor height. All patients were disease free at the moment of recruitment after a minimal follow-up of 2 years.
MAIN OUTCOME MEASURES:Quality of life was measured by validated questionnaires covering general quality of life (Short Form 36, European Organization for Research and Treatment of Cancer QLQ-C30), disease-specific total mesorectal excision (European Organization for Research and Treatment of Cancer QLQ-CR38), defecation problems (Vaizey and low anterior resection syndrome scores), sexual problems (International Index of Erectile Function and Female Sexual Function Index), and urinary dysfunction (International Prostate Symptom Score).
RESULTS:The watch-and-wait group showed better physical and cognitive function, better physical and emotional roles, and better global health status compared with the total mesorectal excision group. The watch-and-wait patients showed fewer problems with defecation and sexual and urinary tract function.
LIMITATIONS:This study only focused on watch-and-wait patients who achieved a sustained complete response for 2 years. In addition, this is a study with a limited number of patients and with quality-of-life measurements on nonpredefined and variable intervals after surgery.
CONCLUSIONS:After a successful watch-and-wait approach, the quality of life was better than after chemoradiation and surgery on several domains. However, chemoradiation therapy on its own is not without long-term side effects, because one-third of the watch-and-wait patients experienced major low anterior resection syndrome symptoms, compared with 66.7% of the patients in the total mesorectal excision group. See Video Abstract at http://links.lww.com/DCR/A395.
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 PLAZOLa 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.
Background
The response to chemoradiotherapy (CRT) for rectal cancer can be assessed by clinical examination, consisting of digital rectal examination (DRE) and endoscopy, and by MRI. A high accuracy ...is required to select complete response (CR) for organ-preserving treatment. The aim of this study was to evaluate the value of clinical examination (endoscopy with or without biopsy and DRE), T2W-MRI, and diffusion-weighted MRI (DWI) for the detection of CR after CRT.
Methods
This prospective cohort study in a university hospital recruited 50 patients who underwent clinical assessment (DRE, endoscopy with or without biopsy), T2W-MRI, and DWI at 6–8 weeks after CRT. Confidence levels were used to score the likelihood of CR. The reference standard was histopathology or recurrence-free interval of >12 months in cases of wait-and-see approaches. Diagnostic performance was calculated by area under the receiver operator characteristics curve, with corresponding sensitivities and specificities. Strategies were assessed and compared by use of likelihood ratios.
Results
Seventeen (34 %) of 50 patients had a CR. Areas under the curve were 0.88 (0.78–1.00) for clinical assessment and 0.79 (0.66–0.92) for T2W-MRI and DWI. Combining the modalities led to a posttest probability for predicting a CR of 98 %. Conversely, when all modalities indicated residual tumor, 15 % of patients still experienced CR.
Conclusions
Clinical assessment after CRT is the single most accurate modality for identification of CR after CRT. Addition of MRI with DWI further improves the diagnostic performance, and the combination can be recommended as the optimal strategy for a safe and accurate selection of CR after CRT.
Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC).
Evidence on SNM for ...idiopathic STC is conflicting and of suboptimal methodological quality.
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.
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.
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.
Background Long-term results of large patient cohorts with fecal incontinence treated by sacral neuromodulation are limited. This study shows the long-term results after a mean follow-up of 7.1 years ...in 325 patients with fecal incontinence treated by continuous sacral neuromodulation. Methods All patients with fecal incontinence and eligible for sacral neuromodulation between 2000 and 2015 were evaluated retrospectively. Primary outcome was a decrease in episodes of fecal incontinence, which was defined as involuntary fecal loss at least once per week and documented by a 3 week bowel habit diary. Quality of life was assessed using the Short-Form 36 and the Fecal Incontinence Quality of Life Score. Results In the study, 374 patients were included for sacral neuromodulation screening and 325 patients (32 male, 9.7%) received permanent, continuous sacral neuromodulation. Mean age was 56.5 years (17–82 years) and mean follow-up was 7.1 years (3.0–183.4 months). In the 325 patients with permanent sacral neuromodulation, fecal incontinence episodes decreased from a mean of 16.1 ± 14.5 to 3.0 ± 3.7 per 3-week period after sacral neuromodulation ( P < .001) according to the bowel habit diary. Sacral neuromodulation was removed due to unsatisfactory results in 81 patients. Quality of life (both Short-Form 36 and Fecal Incontinence Quality of Life Score) showed no significant difference compared with the Dutch population during follow-up. Conclusion Long-term efficacy of sacral neuromodulation can be maintained in about half (52.7%) of all patients screened with sacral neuromodulation for fecal incontinence after a mean follow-up of 7.1 years. Importantly, the quality of life of patients with sacral neuromodulation for fecal incontinence did not differ from the general population.
•Late dose-volume effects of radiotherapy on the anorectal function were studied in rectal cancer patients.•33.3% of the patients had major LARS (Low Anterior Resection Syndrome).•Clustering and urge ...incontinence were the most common complaints.•Trends towards higher Vaizey and LARS scores after higher doses to the anal sphincter complex were observed.
To assess the long-term anorectal function in rectal cancer patients following a watch-and-wait policy after chemoradiotherapy and to investigate the dose–volume effects of radiotherapy on the anorectal function.
Thirty-three patients with primary rectal cancer who were treated with chemoradiotherapy and a watch-and-wait policy with minimum follow-up of 2 years were included. We assessed the anorectal function using anorectal manometry and patient reported outcomes (Vaizey and LARS score). Dose–volume histograms were calculated for the rectum and anal sphincter complex, and associations between the dose–volume parameters and anorectal function were assessed.
Dmean to the rectum and anal sphincter complex was 50.5 Gy and 44.7 Gy, respectively. After a median follow-up of 38 (range 23–116) months, 33.3% of the patients reported major LARS. Mean LARS score was 23.4 ± 11.3 and mean Vaizey score was 4.3 ± 4.1. The most frequent complaints were clustering of defaecation and faecal urgency. Trends towards a higher Vaizey and LARS score after higher anal sphincter complex dose were observed, although these associations were not statistically significant.
This is the first study to investigate the late dose-volume effects of radiotherapy specifically on the anorectal function in rectal cancer patients. One-third of the patients had major LARS and the most frequent reported complaints were clustering and faecal urgency. Additionally, we observed trends towards worse long-term anorectal function after higher anal sphincter complex radiotherapy dose. However, this should be evaluated on a larger scale. Future efforts to minimise the dose to the sphincters could possibly reduce the impact of radiotherapy on the anorectal function.
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