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 ).

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.

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 ).

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.

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.

Couples' catastrophizing and co-rumination: Dyadic diary study of patient fatigue after cancer.

OBJECTIVE: Fatigue is a prevalent and long-lasting symptom among patients with cancer that is known to be worsened by patients' catastrophizing thoughts about their fatigue. Spouses are also burdened by patient fatigue, which may lead them to catastrophize as well. Based on the dyadic coping literature, this study hypothesized that patient and spouse catastrophizing translate into worse fatigue through co-rumination-couples' communications dwelling on the negative aspects of fatigue (H1). While maladaptive for fatigue, co-rumination also was expected to foster couple relationship satisfaction (H2). METHOD: Posttreatment patients with cancer and their spouses (n = 101 dyads) completed daily diaries for 14 days. Patients reported on their momentary fatigue severity. Both couple members reported on their catastrophizing about the patients' fatigue, co-rumination, and their momentary relationship satisfaction. Multilevel structural equation modeling was applied to test within-person actor- and partner-effects between catastrophizing, co-rumination, and changes in fatigue (H1) and between co-rumination and changes in relationship satisfaction (H2). RESULTS: Whereas patient catastrophizing was directly related to their fatigue (b = 0.52, 95% credibility interval [CI] [0.09, 0.95]), as hypothesized, the effect of spouse catastrophizing on patient fatigue was mediated through co-rumination (indirect effect = 0.32, 95% CI [0.07, 0.60]). Unexpectedly, patient- and spouse-reported co-rumination were unrelated to both couple members' relationship satisfaction. CONCLUSIONS: Spouse catastrophizing contributes to patient fatigue severity through couples' ruminative communications. Co-rumination was not related to relationship satisfaction. Reducing patient and spouse catastrophizing and fostering adaptive dyadic communication in daily life could be targets for future interventions aiming to relieve fatigue in patients after completion of cancer treatment. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Application of laser speckle contrast imaging in laparoscopic surgery.

Anastomotic leakage is a worldwide problem in gastrointestinal surgery which seems to be related to the state of microcirculation. Laser speckle contrast imaging (LSCI) could give surgeons insight in the state of microcirculation to attune the site of anastomosis. This work studies the feasibility of LSCI as a tool for this purpose. An experimental setup was developed using a commercially available laparoscopic video system. Laser speckle contrast imaging is capable of detecting ischemic areas on the large intestine. Further research and development are required before adaptation of this technique in the operating room.

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.

Long-term Oncological and Functional Outcomes of Chemoradiotherapy Followed by Organ-Sparing Transanal Endoscopic Microsurgery for Distal Rectal Cancer: The CARTS Study.

Importance: Treatment of rectal cancer is shifting toward organ preservation aiming to reduce surgery-related morbidity. Short-term outcomes of organ-preserving strategies are promising, but long-term outcomes are scarce in the literature. Objective: To explore long-term oncological outcomes and health-related quality of life (HRQL) in patients with cT1-3N0M0 rectal cancer who underwent neoadjuvant chemoradiotherapy (CRT) followed by transanal endoscopic microsurgery (TEM). Design, Setting, and Participants: In this multicenter phase II feasibility study, patients with cT1-3N0M0 rectal cancer admitted to referral centers for rectal cancer throughout the Netherlands between February 2011 and September 2012 were prospectively included. These patients were to be treated with neoadjuvant CRT followed by TEM in case of good response. An intensive follow-up scheme was used to detect local recurrences and/or distant metastases. Data from validated HRQL questionnaires and low anterior resection syndrome questionnaires were collected. Data were analyzed from February 2011 to April 2017. Main Outcomes and Measures: The primary study outcome of the study was the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL. Results: Of the 55 included patients, 30 (55%) were male, and the mean (SD) age was 64 (39-82) years. Patients were followed up for a median (interquartile range) period of 53 (39-57) months. Two patients (4%) died during CRT, 1 (2%) stopped CRT, and 1 (2%) was lost to follow-up. Following CRT, 47 patients (85%) underwent TEM, of whom 35 (74%) were successfully treated with local excision alone. Total mesorectal excision was performed in 16 patients (4 with inadequate responses, 8 with completion after TEM, and 4 with salvage for local recurrence). The actuarial 5-year local recurrence rate was 7.7%, with 5-year disease-free and overall survival rates of 81.6% and 82.8%, respectively. Health-related quality of life during follow-up was equal to baseline, with improved emotional well-being in patients treated with local excision (mean score at baseline, 72.0; 95% CI, 67.1-80.1; mean score at follow-up, 86.9; 95% CI, 79.2-94.7; P = .001). Major, minor, and no low anterior resection syndrome was experienced in 50%, 28%, and 22%, respectively, of patients with successful organ preservation. Conclusions and Relevance: In early-stage rectal cancer (cT1-3N0M0), CRT enables organ preservation with additional TEM surgery in approximately two-thirds of patients with good long-term oncological outcome and HRQL. This multimodality treatment triggers a certain degree of bowel dysfunction, and one-third of patients still undergo radical surgery and are overtreated by CRT.

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.

Long-term Outcome of an Organ Preservation Program After Neoadjuvant Treatment for Rectal Cancer.

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

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.

Validity and reliability of global operative assessment of laparoscopic skills (GOALS) in novice trainees performing a laparoscopic cholecystectomy.

PURPOSE: Global Operative Assessment of Laparoscopic Skills (GOALS) assessment has been designed to evaluate skills in laparoscopic surgery. A longitudinal blinded study of randomized video fragments was conducted to estimate the validity and reliability of GOALS in novice trainees. METHODS: In total, 10 trainees each performed 6 consecutive laparoscopic cholecystectomies. Sixty procedures were recorded on video. Video fragments of (1) opening of the peritoneum; (2) dissection of Calot's triangle and achievement of critical view of safety; and (3) dissection of the gallbladder from the liver bed were blinded, randomized, and rated by 2 consultant surgeons using GOALS. Also, a grade was given for overall competence. The correlation of GOALS with live observation Objective Structured Assessment of Technical Skills (OSATS) scores was calculated. Construct validity was estimated using the Friedman 2-way analysis of variance by ranks and the Wilcoxon signed-rank test. The interrater reliability was calculated using the absolute and consistency agreement 2-way random-effects model intraclass correlation coefficient. RESULTS: A high correlation was found between mean GOALS score (r = 0.879, p = 0.021) and mean OSATS score. The GOALS score increased significantly across the 6 procedures (p = 0.002). The trainees performed significantly better on their sixth when compared with their first cholecystectomy (p = 0.004). The consistency agreement interrater reliability was 0.37 for the mean GOALS score (p = 0.002) and 0.55 for overall competence (p < 0.001) of the 3 video fragments. CONCLUSION: The validity observed in this randomized blinded longitudinal study supports the existing evidence that GOALS is a valid tool for assessment of novice trainees. A relatively low reliability was found in this study.

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).

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.