Better stoma care using the Stoma App: does it help? A first randomized double-blind clinical trial on the effect of mobile healthcare on quality of life in stoma patients.

BACKGROUND: Receiving a stoma significantly impacts patients' quality of life. Coping with this new situation can be difficult, which may result in a variety of physical and psychosocial problems. It is essential to provide adequate guidance to help patients cope with their stoma, as this positively influences self-efficacy in return. Higher self-efficacy reduces psychosocial problems increasing patient's quality of life. This study investigates whether a new mobile application, the Stoma App, improves quality of life. And if personalized guidance, timed support, and peer contact offered as an in-app surplus makes a difference. METHODS: A double-blind, randomized controlled trial was conducted between March 2021 and April 2023. Patients aged > 18 years undergoing ileostomy or colostomy surgery, in possession of a compatible smartphone were included. The intervention group received the full version of the app containing personalized and time guidance, peer support, and generic (non-personalized) stoma-related information. The control group received a restricted version with only generic information. Primary outcome was stoma quality of life. Secondary outcomes included psychological adaption, complications, re-admittance, reoperations, and length of hospital stay. RESULTS: The intervention version of the app was used by 96 patients and the control version by 112 patients. After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month postoperatively (p = 0.038). On secondary outcomes, no significant improvements could be retrieved of the intervention group. CONCLUSION: The Stoma App improves the quality of life of stoma patients. Peer support and personalized guidance are of significant importance in building self-efficacy. It is to be recommended to implement Stoma app-freely available software qualifying as a medical device-in standard stoma care pathways for the benefits of both patients and healthcare providers.

Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial): a study protocol for a stepped-wedge cluster-randomised trial.

BACKGROUND: Colorectal cancer (CRC) is among the most frequently diagnosed cancers. Approximately 20-30% of stage I-III CRC patients develop a recurrent tumour or metastases after curative surgical resection. Post-operative follow-up is indicated for the first five years after curative surgical resection. As intensified follow-up after curative surgical resection has shown no effect on survival, patient organisations and policy makers have advocated for a more patient-centred approach to follow-up. The objective of this study is to successfully implement patient-led, home-based follow-up (PHFU) in six hospitals in The Netherlands, with as ultimate aim to come to a recommendation for a patient-centred follow-up schedule for stage I-III CRC patients treated with surgical resection with curative intent. METHODS: This study is designed as a stepped-wedge cluster-randomised trial (SW-CRT) in six participating centres. During the trial, three centres will implement PHFU after six months; the other three centres will implement PHFU after 12 months of inclusion in the control group. Eligible patients are those with pT2-4N0M0 or pT1-4N1-2M0 CRC, who are 18 years or older and have been free of disease for 12 months after curative surgical resection. The studied intervention is PHFU, starting 12 months after curative resection. The in-hospital, standard-of-care follow-up currently implemented in the participating centres functions as the comparator. The proportion of patients who had contact with the hospital regarding CRC follow-up between 12-24 months after curative surgical resection is the primary endpoint of this study. Quality of life, fear of cancer recurrence, patient satisfaction, cost-effectiveness and survival are the secondary endpoints. DISCUSSION: The results of this study will provide evidence on whether nationwide implementation of PHFU for CRC in The Netherlands will be successful in reducing contact between patient and health care provider. Comparison of PROMs between in-hospital follow-up and PHFU will be provided. Moreover, the cost-effectiveness of PHFU will be assessed. TRIAL REGISTRATION: Dutch Trail Register (NTR): NL9266 (Registered on January 1st, 2021).

A Cost Overview of Minimally Invasive Total Mesorectal Excision in Rectal Cancer Patients: A Population-based Cohort in Experienced Centres.

Background: Total mesorectal excision has been the gold standard for the operative management of rectal cancer. The most frequently used minimally invasive techniques for surgical resection of rectal cancer are laparoscopic, robot-assisted, and transanal total mesorectal excision. As studies comparing the costs of the techniques are lacking, this study aims to provide a cost overview. Method: This retrospective cohort study included patients who underwent total mesorectal resection between 2015 and 2017 at 11 dedicated centers, which completed the learning curve of the specific technique. The primary outcome was total in-hospital costs of each technique up to 30 days after surgery including all major surgical cost drivers, while taking into account different team approaches in the transanal approach. Secondary outcomes were hospitalization and complication rates. Statistical analysis was performed using multivariable linear regression analysis. Results: In total, 949 patients were included, consisting of 446 laparoscopic (47%), 306 (32%) robot-assisted, and 197 (21%) transanal total mesorectal excisions. Total costs were significantly higher for transanal and robot-assisted techniques compared to the laparoscopic technique, with median (interquartile range) for laparoscopic, robot-assisted, and transanal at €10,556 (8,642;13,829), €12,918 (11,196;16,223), and € 13,052 (11,330;16,358), respectively (P < 0.001). Also, the one-team transanal approach showed significant higher operation time and higher costs compared to the two-team approach. Length of stay and postoperative complications did not differ between groups. Conclusion: Transanal and robot-assisted approaches show higher costs during 30-day follow-up compared to laparoscopy with comparable short-term clinical outcomes. Two-team transanal approach is associated with lower total costs compared to the transanal one-team approach.

Evaluation of National Surgical Practice for Lateral Lymph Nodes in Rectal Cancer in an Untrained Setting.

BACKGROUND: Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level. METHODS: Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (≥7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those  undergoing only rectal resection. RESULTS: Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874). CONCLUSION: Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research.

Impact of a diverting ileostomy in total mesorectal excision with primary anastomosis for rectal cancer.

BACKGROUND: The role of diverting ileostomy in total mesorectal excision (TME) for rectal cancer with primary anastomosis is debated. The aim of this study is to gain insight in the clinical consequences of a diverting ileostomy, with respect to stoma rate at one year and stoma-related morbidity. METHODS: Patients undergoing TME with primary anastomosis for rectal cancer between 2015 and 2017 in eleven participating hospitals were included. Retrospectively, two groups were compared: patients with or without diverting ileostomy construction during primary surgery. Primary endpoint was stoma rate at one year. Secondary endpoints were severity and rate of anastomotic leakage, overall morbidity rate within thirty days and stoma (reversal) related morbidity. RESULTS: In 353 out of 595 patients (59.3%) a diverting ileostomy was constructed during primary surgery. Stoma rate at one year was 9.9% in the non-ileostomy group and 18.7% in the ileostomy group (p = 0.003). After correction for confounders, multivariate analysis showed that the construction of a diverting ileostomy during primary surgery was an independent risk factor for stoma at one year (OR 2.563 (95%CI 1.424-4.611), p = 0.002). Anastomotic leakage rate was 17.8% in the non-ileostomy group and 17.2% in the ileostomy group (p = 0.913). Overall 30-days morbidity rate was 37.6% in the non-ileostomy group and 56.1% in the ileostomy group (p < 0.001). Stoma reversal related morbidity rate was 17.9%. CONCLUSIONS: The stoma rate at one year was higher in patients with ileostomy construction during primary surgery. The incidence and severity of anastomotic leakage were not reduced by construction of an ileostomy. The morbidity related to the presence and reversal of a diverting ileostomy was substantial.

Patient- and physician-reported radiation-induced toxicity of short-course radiotherapy with a prolonged interval to surgery for rectal cancer.

AIM: A prolonged interval (>4 weeks) between short-course radiotherapy (25 Gy in five fractions) (SCRT-delay) and total mesorectal excision for rectal cancer has been associated with a decreased postoperative complication rate and offers the possibility of organ preservation in the case of a complete tumour response. This prospective cohort study systematically evaluated patient-reported bowel dysfunction and physician-reported radiation-induced toxicity for 8 weeks following SCRT-delay. METHOD: Patients who were referred for SCRT-delay for intermediate risk, oligometastatic or locally advanced rectal cancer were included. Repeated measurements were done for patient-reported bowel dysfunction (measured by the low anterior resection syndrome [LARS] questionnaire and categorized as no, minor or major LARS) and physician-reported radiation-induced toxicity (according to Common Terminology Criteria for Adverse Events version 4.0) before start of treatment (baseline), at completion of SCRT and 1, 2, 3, 4, 6 and 8 weeks thereafter. RESULTS: Fifty-one patients were included; 31 (61%) were men and the median age was 67 years (range 44-91). Patient-reported bowel dysfunction and physician-reported radiation-induced toxicity peaked at weeks 1-2 after completion of SCRT and gradually declined thereafter. Major LARS was reported by 44 patients (92%) at some time during SCRT-delay. Grade 3 radiation-induced toxicity was reported in 17 patients (33%) and concerned predominantly diarrhoea. No Grade 4-5 radiation-induced toxicity occurred. CONCLUSION: During SCRT-delay, almost every patient experiences temporary mild-moderate radiation-induced toxicity and major LARS, but life-threatening toxicity is rare. SCRT-delay is a safe alternative to SCRT-direct surgery that should be proposed when counselling rectal cancer patients on neoadjuvant strategies.

Improved Postoperative Outcomes after Prehabilitation for Colorectal Cancer Surgery in Older Patients: An Emulated Target Trial.

BACKGROUND: The aim of this study was to assess the effect of a multimodal prehabilitation program on perioperative outcomes in colorectal cancer patients with a higher postoperative complication risk, using an emulated target trial (ETT) design. PATIENTS AND METHODS: An ETT design including overlap weighting based on propensity score was performed. The study consisted of all patients with newly diagnosed colorectal cancer (2016-2021), in a large nonacademic training hospital, who were candidate to elective colorectal cancer surgery and had a higher risk for postoperative complications defined by: age ≥ 65 years and or American Society of Anesthesiologists score III/IV. Intention-to-treat (ITT) and per-protocol analyses were performed to evaluate the effect of prehabilitation compared with usual care on perioperative complications and length of stay (LOS). RESULTS: Two hundred fifty-one patients were included: 128 in the usual care group and 123 patients in the prehabilitation group. In the ITT analysis, the number needed to treat to reduce one or more complications in one person was 4.2 (95% CI 2.6-10). Compared with patients in the usual care group, patients undergoing prehabilitation had a 55% lower comprehensive complication score (95% CI -71 to -32%). There was a 33% reduction (95% CI -44 to -18%) in LOS from 7 to 5 days. CONCLUSIONS: This study showed a clinically relevant reduction of complications and LOS after multimodal prehabilitation in patients undergoing colorectal cancer surgery with a higher postoperative complication risk. The study methodology used may serve as an example for further larger multicenter comparative effectiveness research on prehabilitation.

Comparison of three-year oncological results after restorative low anterior resection, non-restorative low anterior resection and abdominoperineal resection for rectal cancer.

INTRODUCTION: Oncological outcome might be influenced by the type of resection in total mesorectal excision (TME) for rectal cancer. The aim was to see if non-restorative LAR would have worse oncological outcome. A comparison was made between non-restorative low anterior resection (NRLAR), restorative low anterior resection (RLAR) and abdominoperineal resection (APR). MATERIALS AND METHODS: This retrospective cohort included data from patients undergoing TME for rectal cancer between 2015 and 2017 in eleven Dutch hospitals. A comparison was made for each different type of procedure (APR, NRLAR or RLAR). Primary outcome was 3-year overall survival (OS). Secondary outcomes included 3-year disease-free survival (DFS) and 3-year local recurrence (LR) rate. RESULTS: Of 998 patients 363 underwent APR, 132 NRLAR and 503 RLAR. Three-year OS was worse after NRLAR (78.2%) compared to APR (86.3%) and RLAR (92.2%, p < 0.001). This was confirmed in a multivariable Cox regression analysis (HR 1.85 (1.07, 3.19), p = 0.03). The 3-year DFS was also worse after NRLAR (60.3%), compared to APR (70.5%) and RLAR (80.1%, p < 0.001), HR 2.05 (1.42, 2.97), p < 0.001. The LR rate was 14.6% after NRLAR, 5.2% after APR and 4.8% after RLAR (p = 0.005), HR 3.22 (1.61, 6.47), p < 0.001. CONCLUSION: NRLAR might be associated with worse 3-year OS, DFS and LR rate compared to RLAR and APR.

Personal Devices to Monitor Physical Activity and Nutritional Intake After Colorectal Cancer Surgery: Feasibility Study.

BACKGROUND: The use of self-monitoring devices is promising for improving perioperative physical activity and nutritional intake. OBJECTIVE: This study aimed to assess the feasibility, usability, and acceptability of a physical activity tracker and digital food record in persons scheduled for colorectal cancer (CRC) surgery. METHODS: This observational cohort study was conducted at a large training hospital between November 2019 and November 2020. The study population consisted of persons with CRC between 18- and 75 years of age who were able to use a smartphone or tablet and scheduled for elective surgery with curative intent. Excluded were persons not proficient in Dutch or following a protein-restricted diet. Participants used an activity tracker (Fitbit Charge 3) from 4 weeks before until 6 weeks after surgery. In the week before surgery (preoperative) and the fifth week after surgery (postoperative), participants also used a food record for 1 week. They shared their experience regarding usability (system usability scale, range 0-100) and acceptability (net promoter score, range -100 to +100). RESULTS: In total, 28 persons were included (n=16, 57% male, mean age 61, SD 8 years), and 27 shared their experiences. Scores regarding the activity tracker were as follows: preoperative median system usability score, 85 (IQR 73-90); net promoter score, +65; postoperative median system usability score, 78 (IQR 68-85); net promotor score, +67. The net promoter scores regarding the food record were +37 (preoperative) and-7 (postoperative). CONCLUSIONS: The perioperative use of a physical activity tracker is considered feasible, usable, and acceptable by persons with CRC in this study. Preoperatively, the use of a digital food record was acceptable, and postoperatively, the acceptability decreased.

Clinical outcomes of open abdominal wall reconstruction with the use of a polypropylene reinforced tissue matrix: a multicenter retrospective study.

OBJECTIVE: To assess mesh behaviour and clinical outcomes of open complex abdominal wall reconstruction (CAWR) with the use of a polypropylene reinforced tissue matrix. METHODS: A multicenter retrospective study of adult patients who underwent open CAWR with the use of a permanent polypropylene reinforced tissue matrix (OviTex®) between June 2019 and January 2021. RESULTS: Fifty-five consecutive patients from four hospitals in the Netherlands were analysed; 46 patients with a ventral hernia and 9 patients with an open abdomen. Most patients with a ventral hernia had one or more complicating comorbidities (91.3%) and one or more complicating hernia characteristics (95.7%). Most procedures were performed in a (clean) contaminated surgical field (69.6% CDC 2-4; 41.3% CDC 3-4). All nine patients with an open abdomen underwent semi-emergent surgery. Twelve out of 46 patients with a ventral hernia (26.1%) and 4 of 9 patients with an open abdomen (44.4%) developed a postoperative surgical site infection that made direct contact with the mesh as confirmed on computed tomography (CT), suspicious of mesh infection. No patient needed mesh explantation for persistent infection of the mesh. During a median follow-up of 13 months, 4 of 46 ventral hernia patients (8.7%) developed a CT confirmed hernia recurrence. CONCLUSION: Polypropylene reinforced tissue matrix can withstand infectious complications and provides acceptable mid-term recurrence rates in this retrospective study on open complex abdominal wall reconstructions. Longer follow-up data from prospective studies are required to determine further risk of hernia recurrence.

Colonoscopic-Assisted Laparoscopic Wedge Resection for Colonic Lesions: A Prospective Multicenter Cohort Study (LIMERIC-Study).

OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of a modified CAL-WR. SUMMARY BACKGROUND DATA: The use of segmental colectomy in patients with endoscopically unresectable colonic lesions results in significant morbidity and mortality. CAL-WR is an alternative procedure that may reduce morbidity. METHODS: This prospective multicenter study was performed in 13 Dutch hospitals between January 2017 and December 2019. Inclusion criteria were (1) colonic lesions inaccessible using current endoscopic resection techniques (judged by an expert panel), (2) non-lifting residual/recurrent adenomatous tissue after previous polypectomy or (3) an undetermined resection margin after endoscopic removal of a low-risk pathological T1 (pT1) colon carcinoma. Thirty-day morbidity, technical success rate and radicality were evaluated. RESULTS: Of the 118 patients included (56% male, mean age 66 years, standard deviation ± 8 years), 66 (56%) had complex lesions unsuitable for endoscopic removal, 34 (29%) had non-lifting residual/recurrent adenoma after previous polypectomy and 18 (15%) had uncertain resection margins after polypectomy of a pT1 colon carcinoma. CAL-WR was technically successful in 93% and R0 resection was achieved in 91% of patients. Minor complications (Clavien-Dindo i-ii) were noted in 7 patients (6%) and an additional oncologic segmental resection was performed in 12 cases (11%). Residual tissue at the scar was observed in 5% of patients during endoscopic follow-up. CONCLUSIONS: CAL-WR is an effective, organ-preserving approach that results in minor complications and circumvents the need for major surgery. CAL-WR, therefore, deserves consideration when endoscopic excision of circumscribed lesions is impossible or incomplete.

Impact of the COVID-19 pandemic on surgical care in the Netherlands.

BACKGROUND: The COVID-19 pandemic caused disruption of regular healthcare leading to reduced hospital attendances, repurposing of surgical facilities, and cancellation of cancer screening programmes. This study aimed to determine the impact of COVID-19 on surgical care in the Netherlands. METHODS: A nationwide study was conducted in collaboration with the Dutch Institute for Clinical Auditing. Eight surgical audits were expanded with items regarding alterations in scheduling and treatment plans. Data on procedures performed in 2020 were compared with those from a historical cohort (2018-2019). Endpoints included total numbers of procedures performed and altered treatment plans. Secondary endpoints included complication, readmission, and mortality rates. RESULTS: Some 12 154 procedures were performed in participating hospitals in 2020, representing a decrease of 13.6 per cent compared with 2018-2019. The largest reduction (29.2 per cent) was for non-cancer procedures during the first COVID-19 wave. Surgical treatment was postponed for 9.6 per cent of patients. Alterations in surgical treatment plans were observed in 1.7 per cent. Time from diagnosis to surgery decreased (to 28 days in 2020, from 34 days in 2019 and 36 days in 2018; P < 0.001). For cancer-related procedures, duration of hospital stay decreased (5 versus 6 days; P < 0.001). Audit-specific complications, readmission, and mortality rates were unchanged, but ICU admissions decreased (16.5 versus 16.8 per cent; P < 0.001). CONCLUSION: The reduction in the number of surgical operations was greatest for those without cancer. Where surgery was undertaken, it appeared to be delivered safely, with similar complication and mortality rates, fewer admissions to ICU, and a shorter hospital stay.

COVID-19 has had a significant impact on healthcare worldwide. Hospital visits were reduced, operating facilities were used for COVID-19 care, and cancer screening programmes were cancelled. This study describes the impact of the COVID-19 pandemic on Dutch surgical healthcare in 2020. Patterns of care in terms of changed or delayed treatment are described for patients who had surgery in 2020, compared with those who had surgery in 2018­2019. The study found that mainly non-cancer surgical treatments were cancelled during months with high COVID-19 rates. Outcomes for patients undergoing surgery were similar but with fewer ICU admissions and shorter hospital stay. These data provide no insight into the burden endured by patients who had postponed or cancelled operations.

Robot-Assisted Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision: A Retrospective Propensity Score-Matched Cohort Analysis in Experienced Centers.

BACKGROUND: The superiority of robot-assisted over laparoscopic total mesorectal excision has not been proven. Most studies do not consider the learning curve while comparing the surgical technique. OBJECTIVE: This study aims to compare laparoscopic with robot-assisted total mesorectal excision performed by surgeons who completed the learning curve of the technique. DESIGN: This is a multicenter retrospective propensity score-matched analysis. SETTINGS: The study was performed in 2 large, dedicated robot-assisted hospitals and 5 large, dedicated laparoscopic hospitals. PATIENTS: Patients were included if they underwent a robot-assisted or laparoscopic total mesorectal excision for rectal cancer with curative intent at a dedicated center for the minimally invasive technique between January 1, 2015, and December 31, 2017. INTERVENTIONS: We compared robot-assisted with laparoscopic total mesorectal excision. MAIN OUTCOME MEASURES: The main outcome was conversion to laparotomy during surgery. Secondary outcomes were postoperative morbidity and positive circumferential resection margin. RESULTS: A total of 884 patients were included and, after matching, 315 patients per treatment group remained. Conversion was similar between laparoscopic and robot-assisted total mesorectal excision (4.4% vs 2.5% (p = 0.20)). Positive circumferential resection margin was equal (3.2% vs 4.4% (p = 0.41)). Overall morbidity was comparable as well, although a lower rate of wound infections was observed in the robot-assisted group (5.7% vs 1.9% (p = 0.01)). More primary anastomoses were constructed in the robot-assisted group (50.8% vs 68.3% (p < 0.001)). Finally, more open procedures were performed in dedicated laparoscopic centers, with an overrepresentation of cT4N+ tumors in this group. LIMITATIONS: This is a retrospective multicenter cohort; however, propensity score matching was applied to control for confounding by indication. CONCLUSIONS: Robot-assisted and laparoscopic total mesorectal excision are equally safe in terms of short-term outcomes. However, with the robot-assisted approach, more primary anastomoses were constructed, and a lower wound infection rate was observed. See Video Abstract at http://links.lww.com/DCR/B677.ESCISIÓN MESORRECTAL TOTAL ASISTIDA POR ROBOT VERSUS ESCISIÓN MESORRECTAL TOTAL LAPAROSCÓPICA: UNA PUNTUACIÓN DE PROPENSIÓN RETROSPECTIVA ANÁLISIS DE COHORTES EMPAREJADAS EN CENTROS EXPERIMENTADOS. ANTECEDENTES: No se ha demostrado la superioridad de la escisión mesorrectal total asistida por robot sobre la laparoscópica. La mayoría de los estudios no tienen en cuenta la curva de aprendizaje al comparar la técnica quirúrgica. OBJETIVO: Este estudio tiene como objetivo comparar la escisión mesorrectal total laparoscópica con la asistida por robot realizada por cirujanos que completaron la curva de aprendizaje de la técnica. DISEO: Este es un análisis multicéntrico retrospectivo emparejado por puntuación de propensión. AJUSTES: El estudio se realizó en dos grandes hospitales dedicados asistidos por robots y cinco grandes hospitales laparoscópicos dedicados. PACIENTES: Se incluyeron pacientes que se sometieron a escisión mesorrectal total asistida por robot o laparoscópica para cáncer de recto con intención curativa, en un centro dedicado a la técnica mínimamente invasiva entre el 1 de enero de 2015 y el 31 de diciembre de 2017. INTERVENCIONES: Comparamos la escisión mesorrectal total asistida por robot con la laparoscópica. PRINCIPALES MEDIDAS DE RESULTADO: El principal resultado fue la conversión a laparotomía durante la cirugía. Los resultados secundarios fueron la morbilidad posoperatoria y el margen circunferencial positivo. RESULTADOS: Se incluyó a un total de 884 pacientes y, después de emparejar, quedaron 315 pacientes por grupo de tratamiento. La conversión fue similar entre la escisión mesorrectal total laparoscópica y asistida por robot (4,4% frente a 2,5% [p = 0,20]). El margen de resección circunferencial positivo fue igual (3,2% vs 4,4% [p = 0,41]). La morbilidad general también fue comparable, aunque se observó una menor tasa de infecciones de heridas en el grupo asistido por robot (5,7% frente a 1,9% [p = 0,01]). Se construyeron más anastomosis primarias en el grupo asistido por robot (50,8% frente a 68,3% [p < 0,001]). Finalmente, se realizaron procedimientos más abiertos en centros laparoscópicos dedicados, con una sobrerrepresentación de tumores cT4N + en este grupo. LIMITACIONES: Ésta es una cohorte multicéntrica retrospectiva; sin embargo, se aplicó el emparejamiento por puntuación de propensión para controlar los factores de confusión por indicación. CONCLUSIONES: La escisión mesorrectal total asistida por robot y laparoscópica son igualmente seguras en términos de resultados a corto plazo. Sin embargo, con el abordaje asistido por robot, se construyeron más anastomosis primarias y se observó una menor tasa de infección de la herida. Consulte Video Resumen en http://links.lww.com/DCR/B677. (Traducción-Dr. Gonzalo Hagerman).

LekCheck: A Prospective Study to Identify Perioperative Modifiable Risk Factors for Anastomotic Leakage in Colorectal Surgery.

OBJECTIVE: To assess potentially modifiable perioperative risk factors for anastomotic leakage in adult patients undergoing colorectal surgery. SUMMARY BACKGROUND DATA: Colorectal anastomotic leakage (CAL) is the single most important denominator of postoperative outcome after colorectal surgery. To lower the risk of CAL, the current research focused on the association of potentially modifiable risk factors, both surgical and anesthesiological. METHODS: A consecutive series of adult patients undergoing colorectal surgery with primary anastomosis was enrolled from January 2016 to December 2018. Fourteen hospitals in Europe and Australia prospectively collected perioperative data by carrying out the LekCheck, a short checklist carried out in the operating theater as a time-out procedure just prior to the creation of the anastomosis to check perioperative values on 1) general condition 2) local perfusion and oxygenation, 3) contamination, and 4) surgery related factors. Univariate and multivariate logistic regression analysis were performed to identify perioperative potentially modifiable risk factors for CAL. RESULTS: There were 1562 patients included in this study. CAL was reported in 132 (8.5%) patients. Low preoperative hemoglobin (OR 5.40, P < 0.001), contamination of the operative field (OR 2.98, P < 0.001), hyperglycemia (OR 2.80, P = 0.003), duration of surgery of more than 3 hours (OR 1.86, P = 0.010), administration of vasopressors (OR 1.80, P = 0.010), inadequate timing of preoperative antibiotic prophylaxis (OR 1.62, P = 0.047), and application of epidural analgesia (OR, 1.81, P = 0. 014) were all associated with CAL. CONCLUSIONS: This study identified 7 perioperative potentially modifiable risk factors for CAL. The results enable the development of a multimodal and multidisciplinary strategy to create an optimal perioperative condition to finally lower CAL rates.

The impact of the implementation of physician assistants in inpatient care: A multicenter matched-controlled study.

BACKGROUND: Medical care for admitted patients in hospitals is increasingly reallocated to physician assistants (PAs). There is limited evidence about the consequences for the quality and safety of care. This study aimed to determine the effects of substitution of inpatient care from medical doctors (MDs) to PAs on patients' length of stay (LOS), quality and safety of care, and patient experiences with the provided care. METHODS: In a multicenter matched-controlled study, the traditional model in which only MDs are employed for inpatient care (MD model) was compared with a mixed model in which besides MDs also PAs are employed (PA/MD model). Thirty-four wards were recruited across the Netherlands. Patients were followed from admission till one month after discharge. Primary outcome measure was patients' LOS. Secondary outcomes concerned eleven indicators for quality and safety of inpatient care and patients' experiences with the provided care. RESULTS: Data on 2,307 patients from 34 hospital wards was available. The involvement of PAs was not significantly associated with LOS (ß 1.20, 95%CI 0.99-1.40, p = .062). None of the indicators for quality and safety of care were different between study arms. However, the involvement of PAs was associated with better experiences of patients (ß 0.49, 95% CI 0.22-0.76, p = .001). CONCLUSIONS: This study did not find differences regarding LOS and quality of care between wards on which PAs, in collaboration with MDs, provided medical care for the admitted patients, and wards on which only MDs provided medical care. Employing PAs seems to be safe and seems to lead to better patient experiences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01835444.

Development and evaluation of an interactive simulation module to train the use of an electrosurgical device.

BACKGROUND: The purpose of this study was to develop and evaluate an interactive Web-based training module for electrosurgery and use of an electrosurgical device. MATERIALS AND METHODS: The training module consists of a theoretical part, a device tutorial, and an assessment. For evaluation, participants were recruited at the surgical departments from a university hospital and a non-university teaching hospital and were divided into a training group and a control group. All participants performed the same theoretical and practical tests. The training participants first completed the module before they performed the tests. The control participants immediately performed the tests. Results were compared between the training and control participants. To evaluate face validity, the training participants filled out a questionnaire on their opinion about the module. RESULTS: In total, 39 participants were enrolled in the study: 20 in the training group and 19 in the control group. The training group answered significantly more theoretical questions correctly (15.7 versus 9.7; P<.001) and made significantly fewer errors in the practical test (2.2 versus 5.6; P=.007). The participants in the training group rated the usefulness and characteristics of the module with high marks. All of them indicated the module to be of additive value to surgical training programs. CONCLUSIONS: Training with an interactive Web-based module has a positive effect on both theoretical and practical competence regarding electrosurgery and use of an electrosurgical device. This module was rated positively by the participants and was indicated to be a useful addition to surgical training programs.

Validation of an interactive simulation module to train the use of a laparoscopic insufflator.

BACKGROUND: The purpose of this study was to determine construct and face validities of an interactive Web-based module for pneumoperitoneum and insufflator. METHODS: Participants were recruited from surgical departments in 2 academic hospitals and 1 large nonacademic teaching hospital. They were stratified into 3 groups based on their laparoscopic experience (A, no experience; B, experience as assistant; and C, experience as primary surgeon). Within each group the participants were randomized into a training subgroup and a control subgroup. All participants performed a theoretical and a practical test. The training participants first completed the module before they performed the tests. The control participants immediately performed the tests. Results were compared between the training and control participants. All training participants filled out a questionnaire on their opinion about the module. RESULTS: In total, 40 participants were enrolled in the study: group A consisted of 20 participants and groups B and C both consisted of 10 participants. The trained participants answered significantly more theoretical questions correctly (8.3 vs 6.6; P < .001), correctly identified more alarm causes (91% vs 86%; P = .014) and made significantly less errors in the practical test (1.5 vs 3.6; P = .001). All 20 trained participants rated the module fairly good and indicated the module to be of additive value to surgical training programs. CONCLUSIONS: Training with the interactive web-based module on installation of a pneumoperitoneum and use of an insufflator has a positive effect on both theoretical and practical competence. Construct and face validities were established for this module.