Nationwide standardization of minimally invasive right hemicolectomy for colon cancer and development and validation of a video-based competency assessment tool (the Right study).

BACKGROUND: Substantial variation exists when performing a minimally invasive right hemicolectomy (MIRH) due to disparities in training, expertise and differences in implementation of innovations. This study aimed to achieve national consensus on an optimal and standardized MIRH technique for colon cancer and to develop and validate a video-based competency assessment tool (CAT) for MIRH. METHOD: Statements covering all elements of MIRH were formulated. Subsequently, the Delphi technique was used to reach consensus on a standardized MIRH among 76 colorectal surgeons from 43 different centres. A CAT was developed based on the Delphi results. Nine surgeons assessed the same 12 unedited full-length videos using the CAT, allowing evaluation of the intraclass correlation coefficient (ICC). RESULTS: After three Delphi rounds, consensus (≥80% agreement) was achieved on 23 of the 24 statements. Consensus statements included the use of low intra-abdominal pressure, detailed anatomical outline how to perform complete mesocolic excision with central vascular ligation, the creation of an intracorporeal anastomosis, and specimen extraction through a Pfannenstiel incision using a wound protector. The CAT included seven consecutive steps to measure competency of the MIRH and showed high consistency among surgeons with an overall ICC of 0.923. CONCLUSION: Nationwide consensus on a standardized and optimized technique of MIRH was reached. The CAT developed showed excellent interrater reliability. These achievements are crucial steps to an ongoing nationwide quality improvement project (the Right study).

The Effect of a Temporary Stoma on Long-term Functional Outcomes Following Surgery for Rectal Cancer.

BACKGROUND: Patients with rectal cancer may undergo surgical resection with or without a temporary stoma. OBJECTIVE: This study primarily aimed to compare long-term functional outcomes between patients with and without a temporary stoma after surgery for rectal cancer. The secondary aim was to investigate the effect of time to stoma reversal on functional outcomes. DESIGN: This was a multicenter, cross-sectional study. SETTINGS: This study was conducted at 7 Dutch hospitals. PATIENTS: Included were patients who had undergone rectal cancer surgery (2009-2015). Excluded were deceased patients, who were deceased, had a permanent stoma, or had intellectual disability. MAIN OUTCOME MEASURES: Functional outcomes were measured using the Rome IV criteria for constipation and fecal incontinence and the low anterior resection syndrome score. RESULTS: Of 656 patients, 32% received a temporary ileostomy and 20% a temporary colostomy (86% response). Follow-up was at 56 (interquartile range, 38.5-79) months. Patients who had a temporary ileostomy experienced less constipation, more fecal incontinence, and more major low anterior resection syndrome than those without a temporary stoma. Patients who had a temporary colostomy experienced more major low anterior resection syndrome than those without a temporary stoma. A temporary ileostomy or colostomy was not associated with constipation or fecal incontinence after correction for confounding factors (eg, anastomotic height, anastomotic leakage, radiotherapy). Time to stoma reversal was not associated with constipation, fecal incontinence, or major low anterior resection syndrome. LIMITATIONS: Cross-sectional design. CONCLUSIONS: Although patients with a temporary ileostomy or colostomy have worse functional outcomes in the long term, it seems that the reason for creating a temporary stoma, rather than the stoma itself, underlies this phenomenon. Time to reversal of a temporary stoma does not influence functional outcomes. See Video Abstract . EL EFECTO DEL ESTOMA TEMPORAL SOBRE LOS RESULTADOS FUNCIONALES A LARGO PLAZO DESPUS DE LA CIRUGA POR CNCER DE RECTO: ANTECEDENTES:Los pacientes con cáncer de recto pueden someterse a resección quirúrgica con o sin un estoma temporal.OBJETIVO:El objetivo principal de este estudio fue comparar los resultados funcionales a largo plazo entre pacientes con y sin estoma temporal después de cirugía por cáncer de recto. El objetivo secundario fue investigar el efecto del tiempo transcurrido hasta la reversión del estoma sobre los resultados funcionales.DISEÑO:Este fue un estudio transversal multicéntrico.ESCENARIO:Este estudio se llevó a cabo en siete hospitales holandeses.PACIENTES:Se incluyeron pacientes sometidos a cirugía de cáncer de recto (2009-2015). Se excluyeron pacientes fallecidos, pacientes con estoma permanente o discapacidad intelectual.PRINCIPALES MEDIDAS DE RESULTADO:Los resultados funcionales se midieron utilizando los criterios de Roma IV para el estreñimiento y la incontinencia fecal y la puntuación del síndrome de resección anterior baja (LARS).RESULTADOS:De 656 pacientes, el 32% recibió una ileostomía temporal y el 20% una colostomía temporal (respuesta del 86%). El seguimiento fue de 56.0 (RIQ 38.5-79.0) meses. Los pacientes a los que se les realizó una ileostomía temporal experimentaron menos estreñimiento, más incontinencia fecal y más LARS mayor que los pacientes sin un estoma temporal. Los pacientes que tuvieron una colostomía temporal experimentaron más LARS mayor que los pacientes sin un estoma temporal. Una ileostomía o colostomía temporal no se asoció con estreñimiento o incontinencia fecal después de la corrección de factores de confusión (p. ej., altura anastomótica, fuga anastomótica, radioterapia). El tiempo hasta la reversión del estoma no se asoció con estreñimiento, incontinencia fecal o LARS mayor.LIMITACIONES:El presente estudio está limitado por su diseño transversal.CONCLUSIONES:Aunque los pacientes con una ileostomía o colostomía temporal tienen peores resultados funcionales a largo plazo, parece que la razón para crear un estoma temporal, más que el estoma en sí, se asocia a este fenómeno. El tiempo hasta la reversión de un estoma temporal no influye en los resultados funcionales. (Traducción-Dr. Jorge Silva Velazco ).

Anastomotic Height Is a Valuable Indicator of Long-term Bowel Function Following Surgery for Rectal Cancer.

BACKGROUND: The exact relation between anastomotic height after rectal cancer surgery and postoperative bowel function problems has not been investigated in the long term, resulting in ineffective treatment. OBJECTIVE: The goal of this study was to determine the effect of anastomotic height on long-term bowel function and generic quality of life. DESIGN: This was a multicenter, cross-sectional study. SETTINGS: Seven hospitals in the north of the Netherlands participated. PATIENTS: All patients who underwent rectal cancer surgery between 2009 and 2015 in participating hospitals received the validated Defecation and Fecal Continence and Short-Form 36 questionnaires. Deceased patients, patients with a permanent stoma or an anastomosis >15 cm from the anal verge, patients with intellectual disability, and patients living abroad were excluded. MAIN OUTCOME MEASURES: Primary outcomes were constipation (Rome IV), fecal incontinence (Rome IV), and major low anterior resection syndrome. Secondary outcomes were the generic quality of life scores. RESULTS: The study population ( n = 630) had a median follow-up of 58.0 months. In multivariable analysis, constipation (OR = 1.08; 95% CI, 1.02-1.15; p = 0.011), fecal incontinence (OR = 0.91; 95% CI, 0.84-0.97; p = 0.006), and major low anterior resection syndrome (OR = 0.93; 95% CI, 0.87-0.99; p = 0.027), were significantly associated with anastomotic height. The curves illustrating the probability of constipation and fecal incontinence crossed at an anastomotic height of 7 cm, with 95% CIs overlapping between 4.5 and 9.5 cm. There was no relation between quality-of-life scores and anastomotic height. LIMITATIONS: The study is limited by its cross-sectional design. CONCLUSIONS: This study might serve as a guide for the clinician to effectively screen and treat fecal incontinence and constipation during patient follow-up after rectal cancer surgery. More attention should be paid to fecal incontinence in patients with an anastomosis below 4.5 cm and toward constipation in patients with an anastomosis above 9.5 cm. See Video Abstract at http://links.lww.com/DCR/B858 . LA ALTURA ANASTOMTICA ES UN INDICADOR VALIOSO DE LA FUNCIN INTESTINAL A LARGO PLAZO DESPUS DE LA CIRUGA PARA EL CNCER DE RECTO: ANTECEDENTES:La relación exacta entre la altura anastomótica después de la cirugía de cáncer de recto y los problemas posoperatorios de la función intestinal no se ha investigado a largo plazo, lo que causa un tratamiento ineficaz.OBJETIVO:Determinar el efecto de la altura anastomótica sobre la función intestinal a largo plazo y la calidad de vida genérica.DISEÑO:Estudio multicéntrico transversal.DISEÑO DEL ESTUDIO:Participaron siete hospitales holandeses en el norte de los Países Bajos.PACIENTES:Todos los pacientes que se sometieron a cirugía de cáncer de recto entre 2009 y 2015 en los hospitales participantes recibieron los cuestionarios validados de Defecación y Continencia Fecal y Short-Form 36. Se excluyeron pacientes fallecidos, pacientes con estoma permanente o anastomosis > 15 cm del borde anal, discapacidad intelectual o residentes en el extranjero.PRINCIPALES MEDIDAS DE RESULTADO:Los resultados primarios fueron estreñimiento (Roma IV), incontinencia fecal (Roma IV) y síndrome de resección anterior baja mayor. Los resultados secundarios fueron las puntuaciones genéricas de calidad de vida.RESULTADOS:La población de estudio (N = 630) tuvo una mediana de seguimiento de 58.0 meses. En el análisis multivariable el estreñimiento (OR = 1,08, IC del 95%, 1,02-1,15, p = 0,011), incontinencia fecal (OR = 0,91, IC del 95%, 0,84-0,97, p = 0,006) y síndrome de resección anterior baja mayor (OR = 0,93, IC del 95%, 0,87-0,99, p = 0,027) se asociaron significativamente con la altura anastomótica. Las curvas que ilustran la probabilidad de estreñimiento e incontinencia fecal se cruzaron a una altura anastomótica de 7 cm, con IC del 95% superpuestos entre 4,5 y 9,5 cm. No hubo relación entre las puntuaciones de calidad de vida y la altura anastomótica.LIMITACIONES:El estudio está limitado por su diseño transversal.CONCLUSIONES:Este estudio podría servir como una guía para que el médico evalúe y trate eficazmente la incontinencia fecal y el estreñimiento durante el seguimiento de los pacientes después de la cirugía de cáncer de recto. Se debe prestar más atención a la incontinencia fecal en pacientes con anastomosis por debajo de 4,5 cm y al estreñimiento en pacientes con anastomosis por encima de 9,5 cm. Consulte Video Resumen en http://links.lww.com/DCR/B858 . (Traducción-Dr. Yazmin Berrones-Medina ).

Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh With Primary Perineal Wound Closure After Extralevator Abdominoperineal Resection (BIOPEX-study).

OBJECTIVE: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia. SUMMARY BACKGROUND DATA: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing). METHODS: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic. RESULTS: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome. CONCLUSIONS: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.

Long-term Bowel Dysfunction and Decline in Quality of Life Following Surgery for Colon Cancer: Call for Personalized Screening and Treatment.

BACKGROUND: Differences in long-term outcomes regarding types of colon resections are inconclusive, precluding patient counseling, effective screening, and personalized treatment. OBJECTIVE: This study aimed to compare long-term bowel function and quality of life in patients who underwent right or left hemicolectomy or sigmoid colon resection. DESIGN: This was a multicenter cross-sectional study. SETTINGS: Seven Dutch hospitals participated in this study. PATIENTS: This study included patients who underwent right or left hemicolectomy or sigmoid colon resection without construction of a permanent stoma between 2009 and 2015. Patients who were deceased, mentally impaired, or living abroad were excluded. Eligible patients were sent the validated Defecation and Fecal Continence and Short-Form 36 questionnaires. MAIN OUTCOME MEASURES: Constipation, fecal incontinence (both Rome IV criteria), separate bowel symptoms, and generic quality of life were the main outcomes assessed. RESULTS: This study included 673 patients who underwent right hemicolectomy, 167 who underwent left hemicolectomy, and 284 who underwent sigmoid colon resection. The median follow-up was 56 months. Sigmoid colon resection increased the likelihood of constipation compared to right and left hemicolectomy (OR, 2.92; 95% CI, 1.80-4.75; p < 0.001 and OR, 1.93; 95% CI, 1.12-3.35; p = 0.019). Liquid incontinence and fecal urgency increased after right hemicolectomy compared to sigmoid colon resection (OR, 2.15; 95% CI, 1.47-3.16; p < 0.001 and OR, 2.01; 95% CI, 1.47-2.74; p < 0.001). Scores on quality-of-life domains were found to be significantly lower after right hemicolectomy. LIMITATIONS: Because of the cross-sectional design, longitudinal data are still lacking. CONCLUSIONS: Different long-term bowel function problems occur after right or left hemicolectomy or sigmoid colon resection. The latter seems to be associated with more constipation than right or left hemicolectomy. Liquid incontinence and fecal urgency seem to be associated with right hemicolectomy, which may explain the decline in physical and mental generic quality of life of these patients. See Video Abstract at http://links.lww.com/DCR/C13 . DISFUNCIN INTESTINAL A LARGO PLAZO Y DISMINUCIN DE LA CALIDAD DE VIDA DESPUS DE LA CIRUGA DE CNCER DE COLON SOLICITUD DE DETECCIN Y TRATAMIENTO PERSONALIZADOS: ANTECEDENTES:Las diferencias en los resultados a largo plazo con respecto a los tipos de resecciones de colon no son concluyentes, lo que impide el asesoramiento preoperatorio del paciente y la detección eficaz y el tratamiento personalizado de la disfunción intestinal postoperatoria durante el seguimiento.OBJETIVO:Comparar la función intestinal a largo plazo y la calidad de vida en pacientes sometidos a hemicolectomía derecha o izquierda, o resección de colon sigmoide.DISEÑO:Estudio transversal multicéntrico.AJUSTES:Participaron siete hospitales holandeses.PACIENTES:Se incluyeron pacientes sometidos a hemicolectomía derecha o izquierda, o resección de colon sigmoide sin construcción de estoma permanente entre 2009 y 2015. Se excluyeron pacientes fallecidos, con discapacidad mental o residentes en el extranjero. A los pacientes elegibles se les enviaron los cuestionarios validados de Defecación y Continencia Fecal y Short-Form 36.PRINCIPALES MEDIDAS DE RESULTADO:Se evaluaron el estreñimiento, la incontinencia fecal (ambos criterios de Roma IV), los síntomas intestinales separados y la calidad de vida genérica.RESULTADOS:Se incluyeron 673 pacientes con hemicolectomía derecha, 167 con hemicolectomía izquierda y 284 con resección de colon sigmoide. La mediana de seguimiento fue de 56 meses (RIC 41-80). La resección del colon sigmoide aumentó la probabilidad de estreñimiento en comparación con la hemicolectomía derecha e izquierda (OR, 2,92, IC 95%, 1,80-4,75, p < 0,001 y OR 1,93, IC 95%, 1,12-3,35, p = 0,019). La incontinencia de líquidos y la urgencia fecal aumentaron después de la hemicolectomía derecha en comparación con la resección del colon sigmoide (OR, 2,15, IC 95%, 1,47-3,16, p < 0,001 y OR 2,01, IC 95%, 1,47-2,74, p < 0,001). Las puntuaciones en los dominios de calidad de vida fueron significativamente más bajas después de la hemicolectomía derecha.LIMITACIONES:Debido al diseño transversal, aún faltan datos longitudinales.CONCLUSIONES:Se producen diferentes problemas de función intestinal a largo plazo después de la hemicolectomía derecha o izquierda, o la resección del colon sigmoide. Este último parece estar asociado con más estreñimiento que la hemicolectomía derecha o izquierda. La incontinencia de líquidos y la urgencia fecal parecen estar asociadas a la hemicolectomía derecha, lo que puede explicar el deterioro de la calidad de vida física y mental en general de estos pacientes. Consulte Video Resumen en http://links.lww.com/DCR/C13 . (Traducción-Dr. Yolanda Colorado ).

Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial.

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.

Reasons for low uptake of a psychological intervention offered to cancer survivors with elevated depressive symptoms.

OBJECTIVE: In line with screening guidelines, cancer survivors were consecutively screened on depressive symptoms (as part of standard care), with those reporting elevated levels of symptoms offered psychological care as part of a trial. Because of the low uptake, no conclusions could be drawn about the interventions' efficacy. Given the trial set-up (following screening guidelines and strict methodological quality criteria), we believe that this observational study reporting the flow of participation, reasons for and characteristics associated with nonparticipation, adds to the debate about the feasibility and efficiency of screening guidelines. METHODS: Two thousand six hundred eight medium- to long-term cancer survivors were consecutively screened on depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9). Those with moderate depressive symptoms (PHQ-9 ≥ 10) were contacted and informed about the trial. Patient flow and reasons for nonparticipation were carefully monitored. RESULTS: One thousand thirty seven survivors (74.3%) returned the questionnaire, with 147 (7.6%) reporting moderate depressive symptoms. Of this group, 49 survivors (33.3%) were ineligible, including 26 survivors (17.7%) already receiving treatment and another 44 survivors (30.0%) reporting no need for treatment. Only 25 survivors (1.0%) participated in the trial. CONCLUSION: Of the approached survivors for screening, only 1% was eligible and interested in receiving psychological care as part of our trial. Four reasons for nonparticipation were: nonresponse to screening, low levels of depressive symptoms, no need, or already receiving care. Our findings question whether to spend the limited resources in psycho-oncological care on following screening guidelines and the efficiency of using consecutive screening for trial recruitment in cancer survivors.

Organ Preservation in Rectal Cancer After Chemoradiation: Should We Extend the Observation Period in Patients with a Clinical Near-Complete Response?

BACKGROUND: To assess whether extending the observation period in patients with a near clinical complete response (near cCR) after chemoradiation (CRT) leads to an impaired oncological outcome. METHODS: Patients who had a clinical complete response (cCR) 8-10 weeks after CRT restaging with magnetic resonance imaging and endoscopy were offered a watch-and-wait strategy (W&W1), while patients with a near cCR were offered to undergo local excision or a second restaging 6-12 weeks later. Patients who achieved a cCR at the second restaging were also offered a watch-and-wait strategy (W&W2). RESULTS: Overall, 102 patients with a cCR at the first restaging immediately entered the W&W1, while the remaining 68 patients had a near cCR: 19 patients underwent transanal endoscopic microsurgery and 49 patients opted for a second restaging. Additionally, 44/49 (90%) patients showed a cCR at the second restaging and entered the W&W2. Patients in the W&W1 group had a 2-year local regrowth-free rate (LRFR) of 84% and 2-year overall survival (OS) of 99%, while patients in the W&W2 group had a 2-year LRFR of 73% and OS of 98% (p > 0.05). Multivariable Cox regression analyses showed that late inclusion was not a significant predictive factor for higher risk of LR or lower non-regrowth disease-free survival. CONCLUSIONS: Overall, 90% of patients with a near cCR 8-10 weeks after CRT will proceed to a cCR 6-12 weeks later; therefore, it seems logical to extend the observation period rather than to proceed to surgery. Although there is a non-significant increase in local regrowth rate in these patients, it does not seem to impact the oncological outcome.

Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial (the BIOPEX-study).

OBJECTIVE: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR). BACKGROUND: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing. METHODS: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year. RESULTS: In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316). CONCLUSIONS: Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.

The predictive value of aptitude assessment in laparoscopic surgery: a meta-analysis.

CONTEXT: Current methods of assessing candidates for medical specialties that involve laparoscopic skills suffer from a lack of instruments to assess the ability to work in a minimally invasive surgery environment. OBJECTIVES: A meta-analysis was conducted to investigate whether aptitude assessment can be used to predict variability in the acquisition and performance of laparoscopic skills. METHODS: PubMed, PsycINFO and Google Scholar were searched to November 2014 for published and unpublished studies reporting the measurement of a form of aptitude for laparoscopic skills. The quality of studies was assessed with QUADAS-2. Summary correlations were calculated using a random-effects model. RESULTS: Thirty-four studies were found to be eligible for inclusion; six of these studies used an operating room performance measurement. Laparoscopic skills correlated significantly with visual-spatial ability (r = 0.32, 95% confidence interval [CI] 0.25-0.39; p < 0.001), perceptual ability (r = 0.31, 95% CI 0.22-0.39; p < 0.001), psychomotor ability (r = 0.26, 95% CI 0.10-0.40; p = 0.003) and simulator-based assessment of aptitude (r = 0.64, 95% CI 0.52-0.73; p < 0.001). Three-dimensional dynamic visual-spatial ability showed a significantly higher correlation than intrinsic static visual-spatial ability (p = 0.024). CONCLUSIONS: In general, aptitude assessments are associated with laparoscopic skill level. Simulator-based assessment of aptitude appears to have the potential to represent a job sample and to enable the assessment of all forms of aptitude for laparoscopic surgery at once. A laparoscopy aptitude test can be a valuable additional tool in the assessment of candidates for medical specialties that require laparoscopic skills.

Assessment of Clinical Complete Response After Chemoradiation for Rectal Cancer with Digital Rectal Examination, Endoscopy, and MRI: Selection for Organ-Saving Treatment.

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.

Ergonomic assessment of the French and American position for laparoscopic cholecystectomy in the MIS Suite.

BACKGROUND: Cholecystectomy was one of the first surgical procedures to be performed with laparoscopy in the 1980s. Currently, two operation setups generally are used to perform a laparoscopic cholecystectomy: the French and the American position. In the French position, the patient lies in the lithotomy position, whereas in the American position, the patient lies supine with the left arm in abduction. To find an ergonomic difference between the two operation setups the movements of the surgeon's vertebral column were analyzed in a crossover study. METHODS: The posture of the surgeon's vertebral column was recorded intraoperatively using an electromagnetic motion-tracking system with three sensors attached to the head and to the trunk at the levels of Th1 and S1. A three-dimensional posture analysis of the cervical and thoracolumbar spine was performed to evaluate four surgeons removing a gallbladder in the French and American position. The body angles assessed were flexion/extension of the cervical and thoracolumbar spine, axial rotation of the cervical and thoracolumbar spine, lateroflexion of the cervical and thoracolumbar spine, and the orientation of the head in the sagittal plane. For each body angle, the mean, the percentage of operation time within an ergonomic acceptable range, and the relative frequencies were calculated and compared. RESULTS: No statistical difference was observed in the mean body angles or in the percentages of operation time within an acceptable range between the French and the American position. The relative frequencies of the body angles might indicate a trend toward slight thoracolumbar flexion in the French position. CONCLUSION: In a modern dedicated minimally invasive surgery suite, the body posture of the neck and trunk and the orientation of the head did not differ significantly between the French and American position.

The interplay between partners' responsiveness and patients' need for emotional expression in couples coping with cancer.

The central aim of this longitudinal observational study was to test whether patients with a high need for emotional expression are especially sensitive to their partners' responsive behavior, and therefore at risk for depressive symptoms when responsiveness is withheld. Patients with colorectal cancer and their partners (n = 58) participated in a longitudinal study (3, 5 and 9 months after the diagnosis). Additionally to self-report measurements (i.e., patients' need for emotional expression, patients' depressive symptoms and patients' relationship satisfaction) couples were videotaped discussing cancer-related concerns. External observers coded partners' responsiveness (i.e., understanding, validation and caring) and patients' self-disclosures. Partner responsiveness predicted lower levels of depressive symptoms over time in patients who had a relatively high need for emotional expression above and beyond the effect of relationship satisfaction. We demonstrated that partners' understanding and validation are more important in explaining patients' depressive symptoms than partners' caring behavior. Our findings highlight the importance of the relational context in improving adaptation to cancer taking into account individual differences.

Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study).

BACKGROUND: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure. METHODS/DESIGN: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. DISCUSSION: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia. TRAIL REGISTRATION NUMBER: NCT01927497 (Clinicaltrial.gov).

Colorectal surgeons' learning curve of transanal endoscopic microsurgery.

BACKGROUND: Transanal endoscopic microsurgery (TEM) is a technically demanding key technique in minimally invasive rectal surgery. We investigated the learning curve of colorectal surgeons commencing with TEM. METHODS: All TEM procedures of four colorectal surgeons were analyzed. Procedures were ranked chronologically per surgeon. Outcomes included conversion, postoperative complications, procedure time, and recurrence. Backward multivariable regression analysis identified learning curve effects and other predictors. RESULTS: Four surgeons resected 693 rectal lesions [69.9 % adenoma/25.5 % carcinoma; median size 20 cm(2); interquartile range (IQR) 11-35; 7 ± 4 cm ab ano]. A total of 555 resections (80.1 %) were histopathologically radical (R0). Conversion (4.3 %) was influenced by a learning curve [odds ratio (OR) 0.991 per additional procedure; 95 % confidence interval (CI) 0.984-0.998] and by lesion size. Postoperative complications depended only on the individual surgeon and lesion size in benign lesions (10.4 % complications). A learning curve (OR 0.99; 95 % CI 0.988-0.998) and peritoneal entrance affected complications in malignant lesions (13.3 %). Procedure time [median 55 min (IQR 30-90)] was influenced by a learning curve [B -0.11 (95 % CI -0.14 to -0.09)], individual surgeon, single-piece resection, peritoneal entrance, lesion size, and rectal quadrant. Recurrence of benign lesions (4.5 %) depended on lesion size, R0 resection, and prior resection attempts. Recurrence of malignant lesions (8.9 %) depended on 3D stereoscopic view, lesion size, full-thickness resection, and length of follow-up. Recurrence-free survival of patients operated during the 36th through 80th procedure per surgeon was significantly shorter than in patients operated during procedures 1-35 and 81 onwards. CONCLUSIONS: A surgical learning curve affected conversion rate, procedure time, and complication rate. It did not influence recurrence rates, possibly due to evolving patient populations. This first insight into the learning curve of TEM stresses the importance of quality monitoring and centralisation of care.

Structured synchronous implementation of an enhanced recovery program in elective colonic surgery in 33 hospitals in The Netherlands.

BACKGROUND: It has been clearly shown that after elective colorectal surgery patients benefit from multimodal perioperative care programs. The Dutch Institute for Health Care Improvement started a breakthrough project to implement a multimodal perioperative care program of enhanced recovery after surgery (ERAS). This pre/post noncontrolled study evaluated the success of large-scale implementation of the ERAS program for elective colonic surgery using the breakthrough series. METHODS: A total of 33 hospitals participated in this breakthrough project during 2005-2009. Each hospital performed a retrospective chart review to gather information on traditionally treated patients (pre-ERAS group, n = 1,451). During the subsequent year patients were treated according to the ERAS program (ERAS group, n = 1 034). Outcomes were length of stay (LOS), functional recovery, adherence to the protocol, and determinants of reduced LOS. RESULTS: Median LOS decreased significantly from 9 to 6 days (p < 0.001). In the ERAS group, functional recovery was reached within 3 days. Adherence to the protocol elements was high during the preoperative and perioperative phases but slightly lower during the postoperative phase. Younger age, female sex, American Society of Anesthesiologists grades I/II, and laparoscopic surgery were associated with decreased LOS. Care elements that positively influenced LOS were cessation of intravenous fluids and mobilization on postoperative day 1 and administration of laxatives postoperatively. CONCLUSIONS: The ERAS program was successfully implemented in one-third of all Dutch hospitals using the breakthrough series. Participating hospitals reduced the LOS by a median 3 days and were able to improve their standard of care in elective colonic surgery.

Postoperative efficacy and safety of vessel sealing: an experimental study on carotid arteries of the pig.

BACKGROUND: The aim of this preclinical study was to analyze the burst pressure of large in vivo sealed vessels, not just immediately, but also in the first 7 postoperative days. METHODS: In 26 anesthetized pigs, the right carotid artery was sealed and cut using a novel device that integrates bipolar and ultrasonic energy. The animals were then awakened. They underwent a second surgical procedure after different follow-up periods ranging from 1 to 7 days: the left common carotid artery was sealed and cut in the same way as the contralateral artery. Perioperative and postoperative clinical events, evolution of burst pressure over time, and comparison between immediate and delayed burst pressure were analyzed. RESULTS: All sealings were successful. There were no perioperative or postoperative complications. Median immediate (day 0) burst pressure was 949 mmHg (IQR 781-1181). Burst pressure decreased postoperatively but was never below 500 mmHg in any pig. CONCLUSION: Postoperative variations are observed in the burst pressure of in vivo sealed arteries. Immediate burst pressure alone should not be used for validating vascular sealing devices.

Laparoscopic Laser Speckle Contrast Imaging Can Visualize Anastomotic Perfusion: A Demonstration in a Porcine Model.

BACKGROUND: Intestinal resection causes inevitable vascular damage, which cannot always be seen during an intraoperative clinical assessment of local intestinal perfusion. If left unaltered, impaired perfusion can lead to complications, such as anastomotic leakage (AL). Therefore, we demonstrate the use of a novel laparoscopic laser speckle contrast imaging (LSCI)-based approach in order to assess local intestinal perfusion during the construction of intestinal anastomoses. METHODS: Three segments were isolated from the small intestine of a pig, while the perfusion of each was compromised by coagulating 7-8 mesenteric arteries. Both clinical assessments and LSCI were used to detect the induced perfusion deficits and to subsequently guide a transection in either a well perfused, marginally perfused, or poorly perfused tissue area within the segment. Bowel ends were then utilized for the creation of three differently perfused anastomoses: well perfused/well perfused (anastomosis segment 1), well perfused/poorly perfused (anastomosis segment 2), and poorly perfused/poorly perfused (anastomosis segment 3). After construction of the anastomoses, a final perfusion assessment using both clinical assessment and LSCI was executed in order to evaluate the vascular viability of the anastomosis. RESULTS: Laparoscopic LSCI enabled continuous assessment of local intestinal perfusion and allowed for detection of perfusion deficits in real time. The imaging feedback precisely guided the surgical procedure, and, when evaluating the final anastomotic perfusion, LSCI was able to visualize the varying degrees of perfusion, whereas standard clinical assessment yielded only minor differences in visual appearance of the tissue. CONCLUSIONS: In this technical note, we demonstrate a novel LSCI-based approach for intraoperative perfusion assessment. With its ability to continuously visualize perfusion in real time, laparoscopic LSCI has significant potential for the optimization of anastomotic surgery in the near future.

Effect of proctoring on implementation and results of elective laparoscopic colon surgery.

PURPOSE: A steep learning curve exists for surgeons to become skilled in laparoscopic colon resection. Our institute offers a proctored training programme. The purpose of this descriptive study was to evaluate whether the course resulted in adoption of laparoscopic colorectal surgery into clinical practice, explore post-course practice patterns and analyse the outcome of surgical performance. METHODS: Between 2003 and 2008, 26 surgeons were trained by our institute. The course consisted of 24 elective laparoscopic resections under direct supervision. A questionnaire and a prospective post-course web-based registration were used to analyse the effect of the training and the outcome of surgical performance. RESULTS: The response rate of the questionnaire was 85%. The majority had not performed any laparoscopic colon resections before attending the course. All 24 respondents successfully implemented laparoscopy into daily practice. After the course, 70% of all sigmoid resections were performed laparoscopically in contrast with 0% of all transverse colon resections. The results of the trainees after following the course are equal to results of other studies. CONCLUSIONS: A proctored training programme, consisting of 24 supervised cases, is safe and feasible. For adequate monitoring, participating in a post-course registry should be obligatory.

Relationship satisfaction in couples confronted with colorectal cancer: the interplay of past and current spousal support.

Based on attribution theory, this study hypthesized that past spousal supportiveness may act as a moderator of the link between one partner's current support behavior and the other partner's relationship satisfaction. A sample of 88 patients with colorectal cancer and their partners completed questionnaires approximately 3 and 9 months after diagnosis. The data were analyzed employing dyadic data analytic approaches. In the short-term, spousal active engagement--which involved discussing feelings and engaging in joint problem solving--was positively associated with relationship satisfaction in patients as well as in partners, but only when past spousal support was relatively low. Spousal protective buffering--which involved hiding worries and fears and avoiding talking about the disease--was negatively associated with relationship satisfaction in patients, again only when past spousal support was relatively low. If past spousal support was high, participants rated the quality of their relationship relatively high, regardless of their partner's current support behavior. Over time, past spousal supportiveness was not found to mitigate the negative association between spousal protective buffering and relationship satisfaction. Overall, our results indicate that relationship satisfaction can be maintained if past spousal supportiveness is high even if the partner is currently not very responsive to the individual's needs, at least in the short-term.